СПОСОБ ИЗМЕРЕНИЯ КОНЦЕНТРАЦИИ АНАЛИЗИРУЕМОГО ВЕЩЕСТВА (ВАРИАНТЫ), ИЗМЕРИТЕЛЬНЫЙ ПРИБОР ДЛЯ ИЗМЕРЕНИЯ КОНЦЕНТРАЦИИ АНАЛИЗИРУЕМОГО ВЕЩЕСТВА

Изобретение относится к электрохимическим средствам для измерения концентрации анализируемого вещества в биологической жидкости. Сущность: Способ включает в себя подачу постоянного тока малой величины через зазор с одновременным контролем разности потенциалов между электродами. Время, когда проба замыкает зазор, отмечается резким падением потенциала. После обнаружения пробы прикладывают постоянное напряжение и контролируют ток и/или заряд, проходящий через пробу, в течение некоторого периода времени. По измеренному току или заряду вычисляют концентрацию анализируемого вещества. Также предложено устройство для измерения концентрации анализируемого вещества. Технический результат изобретения: повышение точности измерения особенно при малых концентрациях анализируемого вещества, снижение влияния шума, использование недорогих электронных элементов для измерения. 3 с. и 12 з.п. ф-лы, 6 ил.

Ловушка ошибок стандартного электрода, определяемая по заданному времени выборки и предварительно определенному времени выборки

Использование: для определения концентрации аналита. Сущность изобретения заключается в том, что система для измерения аналита содержит: тест-полоску, включающую в себя: подложку; множество электродов, соединенных с соответствующими разъемами электродов с реагентом, расположенным рядом с множеством электродов, причем множество электродов содержит: электроды, замеряющие физические характеристики; первый рабочий электрод и второй рабочий электрод; и стандартный электрод; и прибор для измерения аналита, включающий в себя: корпус; разъем порта для тест-полоски, выполненный с возможностью соединения с соответствующими разъемами электродов тест-полоски; и микропроцессор, электрически соединенный с разъемом для тест-полоски, чтобы подавать электрические сигналы или измерять электрические сигналы от упомянутого множества электродов, причем микропроцессор выполнен с возможностью: (a) подавать первый сигнал на электроды, замеряющие физические характеристики, для определения физической характеристики ...

КОМПЕНСАЦИЯ НА ОСНОВЕ НАКЛОНА

Группа изобретений относится к анализу биологических жидкостей различной природы. Способ определения концентрации аналита в образце, включает этапы, на которых: генерируют по меньшей мере одно значение выходного сигнала, зависящее от концентрации аналита в образце; определяют по меньшей мере одно значение ΔS из, по меньшей мере, одного параметра ошибки, при этом по меньшей мере одно значение ΔS представляет собой отклонение наклона или отклонение нормализованного наклона относительно по меньшей мере одной базовой корреляции; компенсируют, упомянутое по меньшей мере одно значение выходного сигнала с помощью по меньшей мере одной базовой корреляции и по меньшей мере одного значения ΔS и определяют концентрацию аналита в образце из упомянутого по меньшей мере одного значения выходного сигнала. Также представлены биосенсорная система для определения концентрации аналита в образце и сенсорная платина для данной биосенсорной системы. Достигается повышение точности и достоверности анализа. 3 н ...

ФЕРМЕНТНЫЙ ЭЛЕКТРОД

Изобретение относится к ферментному электроду, включающему частицы углерода, несущие глюкозодегидрогеназу (GDH) с флавинадениндинуклеотидом (FAD) в качестве кофермента; и электродный слой, контактирующий с указанными частицами углерода, причем частицы углерода и электродный слой состоят из частиц углерода с диаметром частицы не более 100 нм и удельной поверхностью по меньшей мере 200 м/г. Также изобретение относится к способу получения указанного электрода, а также датчику глюкозы и ферментной топливной батарее, использующим данный электрод. Электрод не требует использования медиатора электронов, позволяя получать высокую величину тока отклика и широкий динамический спектр при использовании в качестве датчика глюкозы. 4 н. и 8 з.п. ф-лы, 9 пр., 14 ил.

СТРОБИРОВАННАЯ АМПЕРОМЕТРИЯ

Изобретение относится к области электрохимических методов анализа. Предложена система датчика, устройство и способы для определения концентрации анализируемого вещества в образце. Последовательности стробированных амперометрических импульсов, включающие в себя многочисленные рабочие циклы последовательных возбуждений и релаксаций, обеспечивают более короткое время анализа и/или улучшают точность и/или воспроизводимость анализа. Раскрытые последовательности стробированных амперометрических импульсов могут снижать погрешности анализа, являющиеся результатом гематокритного эффекта, изменения объемов цокольного зазора, неустановившихся режимов, медиаторного фона, недозаполнения, изменений температуры в образце и одиночного набора калибровочных констант. 6 н. и 24 з.п. ф-лы, 3 табл., 11 ил.

ДВУХКАМЕРНАЯ АНАЛИТИЧЕСКАЯ ТЕСТ-ПОЛОСКА

Группа изобретений относится к области измерения аналитов. Аналитическая тест-полоска содержит профилированный определяющий слой, определяющий две разделенные по текучей среде ячейки для пробы, причем каждая ячейка для пробы имеет порт на периметре аналитической тест-полоски и выполнена с возможностью приема соответствующей пробы текучей среды через соответствующий порт; общий электрод, расположенный на определяющем слое и в электрическом соединении с каждой из ячеек для пробы; и два электрода ячеек, каждый электрод в электрическом соединении с соответствующей одной из ячеек для пробы. При этом определяющий слой, общий электрод и электроды ячеек расположены с открытием участка поверхности общего электрода и соответствующих участков поверхности электродов ячеек. Также раскрывается способ анализа пробы текучей среды и система для анализа пробы текучей среды. Группа изобретений обеспечивает надежное нанесение текучей среды в порты тест-полоски. 3 н. и 17 з.п. ф-лы, 5 ил.

БИОСЕНСОР ДЛЯ АВТОМАТИЧЕСКОГО КОДИРОВАНИЯ

... 1. Биосенсор для автоматического кодирования, содержащий:несущую пленку;электродный блок, выполненный на одной поверхности несущей пленки;промежуточный слой, покрытый ферментативным материалом и выполненный с возможностью приема биоматериала; изакрывающий слой, нанесённый на промежуточный слой;где электродный блок состоит из части распознавания кода для автоматического распознавания кода биоматериала и реакционной части для обнаружения сигнала от биоматериала, игде часть распознавания кода содержит часть распознавания, выполненную со считывающим элементом для передачи секции, в которой считывается биосенсор; часть состояния, выполненную со считывающим элементом для передачи секции, в которой обрабатывается информация биосенсора; рабочую часть, выполненную со считывающим элементом для передачи информации биосенсора; и часть сравнения, выполненную с возможностью передачи электрода сравнения.2. Биосенсор по п. 1, где часть распознавания кода дополнительно содержит часть подтверждения, выполненную ...

БИОДАТЧИК, УСТОЙЧИВЫЙ К ЭФФЕКТУ КОФЕЙНОГО ПЯТНА

Раскрыт биодатчик, устойчивый к эффекту кофейного пятна. Биодатчик включает в себя подложку; по меньшей мере один рабочий электрод и по меньшей мере один электрод сравнения, соответственно структурированные на одной поверхности подложки проводящим материалом; слой реагента, имеющий материал, вызывающий электрохимическую реакцию с целевым биоматериалом и нанесенный на заданную площадь одной поверхности подложки, на которой структурированы рабочий электрод и электрод сравнения, так что часть слоя реагента расположена на части рабочего электрода, а другая часть слоя реагента расположена на части электрода сравнения; и слой пленки, расположенный на одной поверхности подложки, на которой структурированы рабочий электрод и электрод сравнения, причем слой пленки имеет щель, простирающуюся с заданной шириной так, что слой реагента обнажен через нее. Каждый из рабочего электрода и электрода сравнения включает в себя выводную часть, расположенную во внешней области щели; реакционную часть, расположенную ...

СПОСОБ ОПРЕДЕЛЕНИЯ КОНЦЕНТРАЦИЙ ПЕРОКСИДА ВОДОРОДА

... 1. Способ определения концентрации глюкозы в образце жидкости, в котором образец жидкости вводят в контакт с глюкозо-оксидазой, а образующееся при этом количество пероксида водорода определяют амперометрически с помощью электродов, к которым приложены различные перепады напряжения, отличающийся тем, что указанный способ включает следующие стадии, на которых осуществляют ! приложение напряжения активации для снижения напряжения и определения концентрации пероксида водорода, ! проведение измерений при напряжении, которое подходит для определения концентрации пероксида водорода в образце жидкости и которое было снижено за счет предварительного приложения напряжения активации, ! проведение измерений, по крайней мере, при одном напряжении, которое подходит для определения в образце жидкости концентрации вещества, действующего как мешающее вещество при определении концентрации пероксида водорода, ! учет влияния мешающего вещества на результат измерений при напряжении, которое подходит для определения ...

ЭЛЕКТРОННОЕ УСТРОЙСТВО С ПЕРЕХОДОМ В РЕЖИМ ГЛУБОКОГО ЭНЕРГОСБЕРЕЖЕНИЯ ПУТЕМ ПРИЛОЖЕНИЯ ПРЯМОГО ИЛИ ГЕНЕРИРОВАННОГО СИГНАЛА И СПОСОБ ПРИМЕНЕНИЯ ТАКОГО ЭЛЕКТРОННОГО УСТРОЙСТВА

... 1. Электронное устройство, содержащее:корпус;электрический схемный блок кнопок;по меньшей мере одну управляемую пользователем кнопку, находящуюся в рабочем соединении с электрическим схемным блоком кнопок;блок микроконтроллера; иэлектрический схемный блок первого включения (FTO), расположенный внутри корпуса и включающий в себя узел активации и контакт приема сигнала, ипричем электрический схемный блок FTO выполнен с возможностью перевода электронного устройства в режим глубокого энергосбережения либо при прямом приложении электрического сигнала к узлу активации со стороны внешнего устройства, либо при приеме сигнала деактивации на контакте приема сигнала, ипричем блок микроконтроллера выполнен с возможностью генерирования сигнала деактивации, принимаемого на контакте приема сигнала, в ответ на внешний командный сигнал, принимаемый блоком микроконтроллера; ипричем электрический схемный блок FTO также выполнен с возможностью прерывания режима глубокого энергосбережения и перевода электронного ...

ПАССИВНОЕ ОБНАРУЖЕНИЕ ПРОБЫ ДЛЯ РЕГУЛИРОВАНИЯ ВРЕМЕНИ НАЧАЛА АНАЛИЗА

... 1. Способ определения присутствия пробы в электрохимическом элементе, содержащий этапы подачи упомянутой пробы в упомянутый электрохимический элемент в отсутствии внешнего сигнала, подаваемого к упомянутому электрохимическому элементу, создания разности потенциалов в упомянутом электрохимическом элементе без подачи внешнего сигнала к электрохимическому элементу, и мониторинга упомянутой разности потенциалов. 2. Способ по п.1, в котором упомянутый электрохимический элемент содержит два электрода, и упомянутый этап создания разности потенциалов содержит снабжение упомянутого электрохимического элемента создающей сигнал системой, причем упомянутую создающую сигнал систему наносят асимметрично на упомянутые электроды. 3. Способ по п.2, в котором этап подачи упомянутой пробы в упомянутый электрохимический элемент содержит приведение упомянутой создающей сигнал системы в контакт с упомянутой пробой, причем в упомянутом электрохимическом элементе возникает электрохимическая реакция. 4. Способ ...

Messvorrichtung mit einem Biosensor

BIODETEKTIONSINSTRUMENT UND AUSWERTUNGSVERFAHREN

Bestimmung von Wasserstoffperoxidkonzentrationen

Zur amperometrischen Bestimmung der Wasserstoffperoxidkonzentration in einer Flüssigkeitsprobe werden an die Elektroden unterschiedliche elektrische Potentialstufen angelegt. Dabei ist mindestens ein Potential zur Messung der Wasserstoffperoxidkonzentration in der Flüssigkeitsprobe geeignet, und mindestens ein weiteres Potential zur Messung der Konzentration einer Substanz in der Flüssigkeitsprobe geeignet, die bei der Messung der Wasserstoffperoxidkonzentration als Störsubstanz wirkt.

Improvements in and relating to sample measurement

Sample measurement system

Integrated lancing device with testing meter

An automated, integrated blood sampling and testing device (e.g. for monitoring blood sugar levels) is in the form of a pen. The device includes a shell 5, multiple drum lancets 8, microchip test strip 10a, a lancet force control 12,12a, testing meter, a gearbox, a touchscreen display 17, touchscreen control buttons 17a,17b, control/test buttons 13-15, and a pen cap with cover 4 and hole 21. The device also has a container 7 and spray nozzle 7a for sterilisation of the lancets 8. The device may connect to a smart phone via a wireless connection. Test button 14 is used for a fasting test, whilst test button 15 is used for a normal test. To operate the device a drum of lancets is loaded, lancet prick force is controlled using gear 12, test button 14 or 15 is pressed, lancet pusher 10 is pushed and the result is displayed on the screen 17.

Hand-held test meter with display illumination adjustment circuit block

A monitoring device

A monitoring device comprises monitoring unit 2 having electroanalytical component (3, Fig. 1) and electrical contact 11, and sensor unit 4 (advantageously disposable) having sensor arrangement (5, Fig. 1) and electrical contact (12, Fig. 3). The monitoring unit 2 and sensor unit 4 are held together releasably, and in electrical communication, by a cooperating attachment arrangement, perhaps base plate (8, Fig 2c) and clip mechanism (9, 10, Fig. 2c). The monitoring unit may have casing 6, maybe sealed, comprising recess 7 with walls 20 and 21 having no sharp internal angles; advantageously, this facilitates easy cleaning. Battery charging unit (17, Fig. 5) may instead be inserted into the recess to charge an internal battery via contact 16. The sensor unit may have flow cell(s) (26, Fig. 1) and fluid input and output (22, 23, Fig. 1). The sensor arrangement may comprise electrochemical or optical sensors, and a recognition substrate (enzyme, antibody etc) which binds to the analyte.

METHOD FOR THE REDUCTION OF THE MESSABWEICHUNG OF AMPEROMETRI BIO SENSORS

PROCEDURE FOR THE DETERMINATION OF CALIBRATION INFORMATION OF ELECTRO-CHEMICAL SENSORS

SYSTEM AND PROCEDURE FOR THE DETERMINATION OF THE ANALYTKONZENTRATION OF MEANS OF TIME-DISSOLVED AMPEROMETRIE

LINK

BIO DETECTION INSTRUMENT AND ANALYSIS PROCEDURE

SMALL-VOLUMED SENSOR TO IN-VITRO REGULATION

BIO SENSOR DEVICE AND ASSOCIATED PROCEDURE FOR THE DETECTION OF KIND AND VOLUME OF A SAMPLE

Micro Biosensor and Method for Reducing Measurement Interference Using the Same

Micro Biosensor and Method for Reducing Measurement Interference Using the Same The present invention provides a micro biosensor for reducing a measurement interference when measuring a target analyte in the biofluid, including: a substrate; a first working electrode configured on the surface, and including a first sensing section; a second working electrode configured on the surface, and including a second sensing section which is configured adjacent to at least one side of the first sensing section; and a chemical reagent covered on at least a portion of the first sensing section for reacting with the target analyte to produce a resultant. When the first working electrode is driven by a first working voltage, the first sensing section measures a physiological signal with respect to the target analyte. When the second working electrode is driven by a second working voltage, the second conductive material can directly consume the interferant so as to continuously reduce the measurement ...

Gated Voltammetry

A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Gated voltammetric pulse sequences including multiple duty cycles of sequential excitations and relaxations may provide a shorter analysis time and/or improve the accuracy and/or precision of the analysis. The disclosed pulse sequences may reduce analysis errors arising from the hematocrit effect, variance in cap-gap volumes, non-steady-state conditions, mediator background, a single set of calibration constants, under-fill, and changes in the active ionizing agent content of the sensor strip.

Oxidizable species as an internal reference for biosensors and method of use

Analyte determination method and analyte meter

Electrochemical analyte measurement method and system

Described and illustrated herein are systems and exemplary methods of operating an analyte measurement system having a meter and a test strip. In one embodiment, the method may be achieved by applying a first test voltage between a reference electrode and a second working electrode and applying a second test voltage between the reference electrode and a first working electrode; measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample containing an analyte is applied to the test strip;; measuring a fifth test current at the first working electrode; estimating a hematocrit- corrected analyte concentration from the first, second, third, fourth and fifth test currents; and annunciating the hematocrit-corrected analyte concentration.

Measuring device and methods for use therewith

Construction and use of micro-electrode arrays

Systems and methods for detection and quantification of analytes

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. In some embodiments, the reader component communicates with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

SYSTEMS AND METHODS FOR DETECTION AND QUANTIFICATION OF ANALYTES

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable 5 sample collection component. In some embodiments, the reader component communicates with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or o contaminants in a sample. XR Ml 00 -_0 ...

System and method for determining hematocrit insensitive glucose concentration

Described are methods and systems to apply a plurality of test voltages to the test strip and measure at least a current transient output resulting from an electrochemical reaction in a test chamber of the test strip so that a glucose concentration can be determined that are generally insensitive to other substances in the body fluid sample that could affect the precision and accuracy of the glucose concentration.

REAGENT COMPOSITION FOR BIOSENSOR AND BIOSENSOR HAVING THE SAME

This invention discloses a reagent composition for a biosensor having high sensitivity which is capable of improving analysis linearity of an analyte such as glucose by reacting an oxidoreductase, a metal-containing complex, and Naphthol Green B, and minimizing blood 5 necessary for measuring blood glucose since it is possible to detect a concentration of a small amount of the analyte, and a biosensor having the same. The reagent composition for a biosensor includes at least two kinds of electron transfer mediators including Naphthol Green B, and an enzyme.

Voltammetric systems for assaying biological analytes

Noninvasive body fluid stress sensing

Electrochemical impedance-based label-free and rapid biosensor for select bodily fluid biomolecule levels. Monoclonal antibodies to of biomolecule such as Cortisol were covalently attached to a 16-mercaptohexadecanoic acid functionalized gold working electrode using zero-length crosslinkers N-(3-dimethylaminopropyl)-N- ethylcarbodiimide and 10mM N-hydroxysulfosuccinimide. Cortisol was detected in phosphate buffered saline (simulated tear fluid) using a simple ferrocyanide reagent with a lower limit of detection of 18.73pM and less than 10% relative standard deviation.

REAGENT COMPOSITION FOR BIOSENSOR AND BIOSENSOR HAVING THE SAME

This invention discloses a reagent composition for a biosensor having high sensitivity which is capable of improving analysis linearity of an analyte such as glucose by reacting an oxidoreductase, a metal-containing complex, and Naphthol Green B, and minimizing blood necessary for measuring blood glucose since it is possible to detect a concentration of a small amount of the analyte, and a biosensor having the same. The reagent composition for a biosensor includes at least two kinds of electron transfer mediators including Naphthol Green B, and an enzyme.

Method and Apparatus for Encoding Test Strips

A test meter for receiving a test strip comprising: a housing; electronic circuitry disposed within the housing; and a strip port connector connected to the electronic circuitry and extending to an opening in the housing, said strip port connector connecting the electronic circuitry with a received test strip. The strip port connector contains a pair of top and bottom contacts, said top and bottorn contacts having a proximal end and a distal end and a central contact portion, the top and bottom contacts of the pair are transversely aligned with one another; and the distal ends of the top and bottom contacts are separated or separable from one another by insertion of a test strip between the opposed contacts. The contacts and the meter are adapted to permit detection of faulty contacts and/or coding associated with an inserted test strip. Sill Replacement Sheet "N N - ~ -A-- <--'~$s9 ~ cx .. ~- -2 r - *- A A ~ -- -A A-A- L~* -'A-.- -A- N> <(I FIG.7 A-A- N -A--- N -A-A 'IA-" AflXl.3 J> x ...

Integrated blood glucose measurement device

Analyte meter with operational range configuration technique

Described are techniques governing the glycemic ranges that are applied and governed in the meter so the user is not required to understand or know the editing rules in order to use or set up the meter. These guiding principles will come into effect each time the user chooses to edit the ranges. There will be appropriate warning messages to inform the user if the user does not set the ranges correctly.

Electrochemical-based analytical test strip with electrode voltage sensing connections and hand-held test meter for use therewith

A hand-held test meter for use with an electro-chemical-based analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing; a strip port connector disposed at least partially within the housing and configured to receive an electro-chemical based analytical test strip; a micro-controller disposed in the housing and configured to generate a micro-controller command signal; an electrode bias drive circuit block disposed in the housing and configured to generate a bias drive signal based on the micro-controller command signal, and a dynamic bias drive adjustment circuit block disposed in the housing and configured to receive at least one sensed electrode voltage and to adjust a bias drive signal from the electrode bias drive circuit block based on the sensed electrode voltage to create an adjusted bias drive signal.

Biointerface layer for analyte sensors

Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise a sensor configured to generate a signal associated with a concentration of an analyte and a sensing membrane located over the sensor. The sensing membrane comprises a biointerface layer which interfaces with a biological fluid containing the analyte to be measured. The biointerface layer comprises a biointerface polymer, wherein the biointerface polymer comprises polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The biointerface layer increases sensor longevity and decrease sensor inaccuracy by inhibiting accumulation of cells, proteins, and other biological species on the outermost layers of the sensor.

Enzyme immobilized adhesive layer for analyte sensors

Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise a sensor configured to generate a signal associated with a concentration of an analyte and a sensing membrane located over the sensor. The sensing membrane comprises an enzyme layer, wherein the enzyme layer comprises an enzyme and a polymer comprising polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The enzyme layer protects the enzyme and prevents it from leaching from the sensing membrane into a host or deactivating.

Gating system and method for biosensor test strips

A system is disclosed, the system comprises a diagnostic test strip having a diagnostic end and a meter contacting end, the meter contacting end having at least one identifying feature that distinguishes the meter contacting end from the diagnostic end; a diagnostic meter configured to read information from the meter contacting end of the test strip when the meter contacting end of the test strip is fully inserted in to the meter; and a port in the meter, the port having a gating mechanism configured to identify the meter contacting end and allow the test strip to be fully inserted into the meter only after the gating mechanism identifies the meter contacting end of the test strip as a proper end for insertion.

CHEMICAL REACTION TIME INSTRUMENTATION

ERROR DETECTION IN ANALYTE MEASUREMENTS BASED ON MEASUREMENT OF SYSTEM RESISTANCE

Measurement of the voltage drop at open circuit due to the series resistance of a working and counter electrode pair in an electrochemical test strip provides error detection for multiple variations in the quality of the test strip, as well as the operation of strip in the test meter. In particular, a single measurement of voltage drop can be used to detect and generate an error message when an incorrect reading is likely to result due to (1) damaged electrode tracks, (2) fouled electrode surfaces, (3) dirty strip contacts, or (4) short circuit between the electrodes.

PASSIVE SAMPLE DETECTION TO INITIATE TIMING OF AN ASSAY

The present invention provides methods and systems for passively and automatically detecting the presence of a sample (the "sample detection phase") upon application of the sample to a biosensor, identifying the sample detection time and then initiating the measurement of a targeted characteristic, e.g., the concentration of one or more analytes, of the sample (the "measurement phase"), immediately upon sample detection. The subject methods and systems do not employ or involve the application of an electrical signal from an external source to the electrochemical cell for purposes of performing the sample detection phase and are, thus, less complicated and involve fewer steps and components.

BIOSENSOR APPARATUS AND METHOD WITH SAMPLE TYPE AND VOLUME DETECTION

A biosensor apparatus and method with sample type and cell volume detection. The apparatus includes a sine wave generator to apply an AC signal to a biosensor cell containing a sample, a current-to-voltage converter, a phase shifter, a square wave generator, a synchronous demodulator, and a low pass filter which yields a signal proportional to the effective capacitance across the biosensor cell, which is proportional to the volume of the sample. In addition, the current-to-voltage converter yields a signal indicative of the type of sample contained within the biosensor cell. The method includes applying a sine wave to the biosensor cell, shifting the phase of the resultant signal, generating a square wave synchronous with the sine wave, demodulating the resultant signal with the square wave, and filtering the demodulated signal to produce a signal proportional to the effective capacitance across the biosensor cell. The biosensor apparatus and method are capable of determining sample type ...

CURRENT-TO-VOLTAGE CONVERTER

An integrated current-to-voltage conversion circuit converts a first current (Is) to an output voltage representative of the first current. The circuit includes a first contact pad (1) and second (2) and third (3) contact pads capable of being coupled across a first resistor (R). A first operational amplifier (OP1) has a first input coupled to the first contact pad for producing a first voltage thereat, a second input for receiving a reference voltage (Vref), and a first output coupled to the third contact pad (3). A second voltage (V1) appears at the third contact pad. A second operational amplifier (OP2) has a second output at which a third voltage (V2) appears, a first input coupled to the second output, and a second input coupled to the second contact pad (2). The output voltage is substantially equal to the difference between the second (V1) and third (V2) voltages.

IMPLANTABLE MICRO-BIOSENSOR AND METHOD FOR OPERATING THE SAME

MICRO BIOSENSOR AND METHOD FOR REDUCING MEASUREMENT INTERFERENCE USING THE SAME

A micro biosensor (10) for reducing a measurement interference when measuring a target analyte in the biofluid, including: a substrate (110); a first working electrode (120) configured on the surface (111), and including a first sensing section (121); a second working electrode (130) configured on the surface (111), and including a second sensing section (131) which is configured adjacent to at least one side of the first sensing section (121); and a chemical reagent (150) covered on at least a portion of the first sensing section (121) for reacting with the target analyte to produce a resultant. When the first working electrode (120) is driven by a first working voltage, the first sensing section (121) measures a physiological signal with respect to the target analyte. When the second working electrode (130) is driven by a second working voltage, the second conductive material (2C) can directly consume the interferant so as to continuously reduce the measurement inference of the physiological ...

METHOD AND SYSTEM FOR QUALITY EVALUATION OF A HANDHELD ANALYTICAL DEVICE

The invention concerns a method and a system for quality evaluation of a handheld analytical device (28), wherein the device (28) is operable by a human user in a sequence of handling steps to test an analyte in a sample fluid applied on a test element (36), the method comprising the steps of (a) programming a handling cycle for a robot (12) having at least one robot arm (20) in order to mimic the sequence of handling steps, (b) operating the device (28) in at least one handling cycle by means of the robot (12), (c) monitoring the operation in step (b) by a control unit (14) to evaluate at least one parameter influencing the quality of the device (28).

BIOINTERFACE LAYER FOR ANALYTE SENSORS

Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise a sensor configured to generate a signal associated with a concentration of an analyte and a sensing membrane located over the sensor. The sensing membrane comprises a biointerface layer which interfaces with a biological fluid containing the analyte to be measured. The biointerface layer comprises a biointerface polymer, wherein the biointerface polymer comprises polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The biointerface layer increases sensor longevity and decrease sensor inaccuracy by inhibiting accumulation of cells, proteins, and other biological species on the outermost layers of the sensor.

REDUCED FRICTION CONNECTOR IN BIOLOGICAL FLUID TEST METER

A connector for establishing electrical connection between a testing device (30) and a test strip (40) with a biological fluid thereon includes a contact pad (42) on the test strip (40), and one or more contact wires in the testing device. When the strip is inserted into the testing device, part of the strip' s end engages a contact portion (72) of a contact wire (60) and deflects it in a direction normal to the direction of insertion. In certain embodiments the radius of curvature (in the direction of insertion) of the contact portion is controlled to reduce abrasion of the strip by the wire. In other embodiments the radius of curvature (perpendicular to the direction of insertion) is controlled to reduce the abrasion of the strip by the wire. Sometimes the contact portion and/or contact pad is plated with a sacrificial material to reduce the coefficient of friction. In other embodiments various numbers of contacts receive the end of the strip substantially simultaneously, or are staggered ...

ELECTROCHEMICAL BIOSENSOR ANALYSIS SYSTEM

An electrochemical biosensor analysis system for analyzing a sample liquid, in particular a body fluid. It comprises a biosensor (2), provided for one-time use, comprising an electrode structure (16) made of at least two electrodes (17, 18), a test field, covering the electrode structure (16) and capable of absorbing the sample liquid, and a defined sample application surface on the top side of the test field. The system also includes an analysis instrument comprising an evaluation unit for determining the desired analysis data.

BIOSENSOR SYSTEM HAVING ENHANCED STABILITY AND HEMATOCRIT PERFORMANCE

The present invention relates to electrochemical sensor strips and methods of determining the concentration of an analyte in a sample or improving the performance of a concentration determination. The electrochemical sensor strips may include at most 8 ?g/mm2 of a mediator. The strips, the strip reagent layer, or the methods may provide for the determination of a concentration value having at least one of a stability bias of less than ±10% after storage at 50° C for 4 weeks when compared to a comparison strip stored at 20° C for 4 weeks, a hematocrit bias of less than ±10% for whole blood samples including from 20 to 60% hematocrit, and a intercept to slope ratio of at most 20 mg/dL. A method of increasing the performance of a quantitative analyte determination also is provided.

METHODS OF SCALING DATA USED TO CONSTRUCT BIOSENSOR ALGORITHMS AS WELL AS DEVICES, APPARATUSES AND SYSTEMS INCORPORATING THE SAME

Methods are disclosed for scaling body fluid analysis data to correct and/or compensate for confounding variables such as hematocrit (Hct), temperature, variations in electrode conductivity or combinations thereof before providing an analyte concentration. The scaling methods utilize current response data obtained from an AC block applied prior to a DC block to minimize the impact of such confounding variables upon the observed DC current response before creating descriptors or algorithms. The scaling methods therefore compensate the measured DC current by using data from the AC block made on the same sample. Also disclosed are devices, apparatuses and systems incorporating the various scaling methods.

SYSTEM AND METHOD FOR DETERMINING HEMATOCRIT INSENSITIVE GLUCOSE CONCENTRATION

Described are methods and systems to apply a plurality of test voltages to the test strip and measure at least a current transient output resulting from an electrochemical reaction in a test chamber of the test strip so that a glucose concentration can be determined that are generally insensitive to other substances in the body fluid sample that could affect the precision and accuracy of the glucose concentration.

LOW FORCE ELECTRICAL CONTACT ON METALIZED DEFORMABLE SUBSTRATES

A system for measuring an analyte of interest in a biological fluid includes a test strip for receiving a sample of the biological fluid having multiple contacts formed thereon. A test device includes a circuit board having multiple conducting strips. A connector assembly is fixed to the circuit board and receives the test strip as the test strip moves in an insertion direction to a test position. The connector assembly includes a connector assembly body and multiple conductors. Each of the conductors includes a conductor contact body fixedly connected to the connector assembly body, and a contact arm integrally connected to the conductor contact body and freely extending entirely in the insertion direction. The contact arm is deflected when directly contacted by one of the multiple contacts of the test strip.

SYSTEMS AND METHODS FOR DETECTION AND QUANTIFICATION OF ANALYTES

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. In some embodiments, the reader component communicates with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

GATED AMPEROMETRY

... ²A sensor system, device, and methods for determining the concentration of an ²analyte in a sample is described. Gated amperometric pulse sequences including ²²multiple duty cycles of sequential excitations and relaxations may provide a ²shorter ²analysis time and/or improve the accuracy and/or precision of the analysis. ²The ²disclosed gated amperometric pulse sequences may reduce analysis errors ²arising from ²the hematocrit effect, variance in cap-gap volumes, non-steady-state ²conditions, mediator ²background, under-fill, temperature changes in the sample, and a single set of ²calibration ²constants.² ...

MEASURING DEVICE AND METHODS FOR USE THEREWITH

The ability to switch at will between amperometric measurements and potentiometric measurements provides great flexibility in performing analyses of unknowns. Apparatus and methods can provide such switching to collect data from an electrochemical cell. The cell may contain a reagent disposed to measure glucose in human blood. In further embodiments, the apparatus comprises a housing (70) and an elongated test strip electrode (90), which may take the form of an optical waveguide. An LED (91) provides illumination and the results of the test are displayed in bar graph form on LCD Display (71).

OPEN CIRCUIT DELAY DEVICES, SYSTEMS, AND METHODS FOR ANALYTE MEASUREMENT

... ²System, circuits, and methods to reduce or eliminate uncompensated voltage ²drop between an ²electrode of an electrochemical cell usable for analyte measurement. In one ²example, a system is ²provided that includes a test strip, a reference voltage circuit, an ²operational amplifier connected ²to the reference voltage circuit to provide a pre-determined fraction of a ²reference voltage ²substantially equal to the test voltage applied to the first line, the ²operational amplifier having an ²output configured for one of a connected or disconnected state to the first ²line, and a processing ²circuit connected to the output of the operational amplifier and the first ²line such that, during a ²disconnected state between the output and the first line, the processing ²circuit remains in ²connection with the first line. In another example, a method of measuring an ²electrochemical ²reaction of an electrochemical cell is provided that includes applying a test ²voltage to the first ²electrode and ...

Gated voltammetry

METHOD AND APPARATUS FOR DETECTION OF ABNORMAL TRACES DURING ELECTROCHEMICAL ANALYTE DETECTION

Detection of abnormal signal traces in electrochemical measurements generated using an electrochemical test strip to which a potential is applied allows for an indication of an erroneous analyte determination. The current trace has an expected shape in which a peak current is observed a time tpeak after which there is a decrease in current. To detect abnormal signal traces, the time tpeak is determined experimentally and compared with an expected value, t'peak, and if the difference between the two values to over a predetermined threshold, an error message is provided to the user instead of a test result. The value of t'peak is determined as a function of a mobility term that is determined during a potentiometry phase following the amperometric measurements. © KIPO & WIPO 2008 ...

IMPURITY BLOCKING LAYER CONTAINING POROUS NANO-SILICA COMPLEX FOR PENETRATING SELECTIVELY GLUCOSE AND METHOD FOR PREPARING THE SAME

Integrated blood glucose measurement device

GATED VOLTAMMETRY

A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Gated voltammetric pulse sequences including multiple duty cycles of sequential excitations and relaxations may provide a shorter analysis time and/or improve the accuracy and/or precision of the analysis. The disclosed pulse sequences may reduce analysis errors arising from the hematocrit effect, variance in cap-gap volumes, non-steady-state conditions, mediator background, a single set of calibration constants, under-fill, and changes in the active ionizing agent content of the sensor strip. © KIPO & WIPO 2008 ...

SAMPLE MEASUREMENT SYSTEM

Compensação baseada em inclinação

Method and system for determining analyte concentration in sample

METHOD AND APPARATUS FOR PROVIDING A STABLE VOLTAGE TO AN ANALYTICAL SYSTEM

A method and apparatus for provide a stable voltage to an electrochemical cell used for measurement of an analyte such as glucose in a liquid sample. The apparatus uses a circuit in which multiple switching positions provide both calibration information for use in calibration of electronic components in the circuit and error checking functionality.

METHOD FOR MEASURING ANALYTE CONCENTRATION IN A LIQUID SAMPLE

The blood glucose analysis technique and system described herein address the issue of hematocrit interference when rapidly detecting glucose concentrations. It addresses this issue by using a differential pulse voltammetry technique in which short high, frequency voltage pulses are applied to keep the diffusion layer within the reagent of the working electrode, and the pulses are applied in a limited voltage window (or range) that is below the peak, diffusion-limited current. The readings below the peak are then used to determine glucose concentrations. With this technique, glucose concentrations can be determined relatively fast (e.g., within 5 seconds) and independently of the hematocrit levels of the fluid being analyzed.

SELF CORRECTION FOR SPATIAL ORIENTATION AND MOTION OF PORTABLE CLINICAL TESTING DEVICES

The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration, motion and orientation of a blood testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof. More particularly, it allows to correct test results which are sensitive to fluidic artefacts such as blood cell sedimentation.

SYSTEM AND METHOD FOR ANALYTE MEASUREMENT USING A NONLINEAR SAMPLE RESPONSE

The systems and methods of the present invention utilize a linear component of a non-linear, Faradaic current response generated by a biological fluid sample when an AC excitation potential sufficient to produce such a Faradaic current response is applied to the sample, in order to calculate the concentration of a medically significant component in the biological fluid sample. The current response is created by the excitation of electrochemical processes within the sample by the applied potential. Typically, the linear component of the current response to an applied AC potential contains phase angle and/or admittance information that may be correlated to the concentration of the medically significant component. Also typically, the fundamental linear component of the current response is utilized in the disclosed systems and methods. Harmonics of the fundamental linear component may also be used. Other methods and devices are disclosed.

ELECTROCHEMICAL ANALYTE MEASUREMENT METHOD AND SYSTEM

Described and illustrated herein are systems and exemplary methods of operating an analyte measurement system having a meter and a test strip. In one embodiment, the method may be achieved by applying a first test voltage between a reference electrode and a second working electrode and applying a second test voltage between the reference electrode and a first working electrode; measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample containing an analyte is applied to the test strip;; measuring a fifth test current at the first working electrode; estimating a hematocrit- corrected analyte concentration from the first, second, third, fourth and fifth test currents; and annunciating the hematocrit-corrected analyte concentration.

TEST STRIP EJECTOR FOR MEDICAL DEVICE

A system (12) for receiving and ejecting a fluid testing device test strip (18) includes a strip connector having first and second guide rails (38, 40), and divider walls (72, 73) each having a channel. A sled (34)has first and second legs (80, 82) connected to a cross member (84). Each leg has a contact leg (94, 96) extending inwardly from a chamfered end. The first and second legs when positioned parallel to the guide rails have the contact leg captured in the divider wall channels (76) retaining the sled (34) in sliding contact with the guide rails (38, 40) for motions in loading and ejection directions (A, B). A mechanism assembly (26) is movably connected to the fluid testing device. The cross member (84) is coupled so operation in a first direction displaces the sled in the loading direction positioning the sled (34) in a test strip test position, and opposite operation positions the contact legs (94, 96) in direct contact with and ejects the test strip (18).

METHOD AND APPARATUS FOR ASSAY OF ELECTROCHEMICAL PROPERTIES

A method for monitoring a select analyte in a sample in an electrochemical system. The method includes applying to the electrochemical system a time-varying potential superimposed on a DC potential to generate a signal; and discerning from the signal a contribution from the select analyte by resolving an estimation equation based on a Faradaic signal component and a nonfaradaic signal component.

ELECTRODES, METHODS, APPARATUSES COMPRISING MICRO-ELECTRODE ARRAYS

Described are micro-arrays of electrodes disposed proximal to a flexible substrate, electronic components and sensors comprising such arrays, and methods of use for such arrays.

TEST UNIT CARTRIDGE FOR ANALYTE TESTING DEVICE

A test unit cartridge for holding a plurality of test units includes a first test unit that contains a first analyte sensor and a second test unit that contains a second analyte sensor. The first and second analyte sensors use first and second reagents to detect first and second analytes, respectively. The first analyte is different from the second analyte and the first and second test units are functionally non-fungible. The plurality of test units can also include a third test unit that contains two analyte sensors having two reagents for detecting two different analytes using one fluid sample. A method of using the test unit cartridge is also described, which comprises loading the cartridge into an analyte testing device and cocking an actuator of the device that is configured to (i) expose an analyte sensor of a test unit, (ii) ready a lancet, and (iii) advance a lancet cartridge.

DEVICES, SYSTEMS AND METHODS TO DETECT VIABLE INFECTIOUS AGENTS IN A FLUID SAMPLE AND SUSCEPTIBILITY OF INFECTIOUS AGENTS TO ANTI-INFECTIVES

Various devices, systems and methods for detecting infectious agents or determining a susceptibility of an infectious agent to an anti-infective are described herein. One example method comprises introducing a fluid sample to a surface; exposing the surface to a solution; sampling the solution after exposing the solution to the surface; and detecting a change in an electrical characteristic of a sensing device exposed to the solution sampled corresponding to a presence of the infectious agent in the fluid sample.

Measuring Device and Methods for Use Therewith

The ability to switch at will between amperometric measurements and potentiometric measurements provides great flexibility in performing analyses of unknowns. Apparatus and methods can provide such switching to collect data from an electrochemical cell. The cell may contain a reagent disposed to measure glucose in human blood.

SYSTEMS AND METHODS FOR DETECTION AND QUANTIFICATION OF ANALYTES

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. In some embodiments, the reader component communicates with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

SYSTEMS AND METHODS FOR FACILITATING FLUID FLOW DURING ENHANCED DETECTION AND QUANTIFICATION OF ANALYTES

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. The reader component may communicate with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

METHOD FOR MEASURING ANALYTE CONCENTRATION IN A LIQUID SAMPLE

The blood glucose analysis technique and system described herein address the issue of hematocrit interference when rapidly detecting glucose concentrations. It addresses this issue by using a differential pulse voltammetry technique in which short high, frequency voltage pulses are applied to keep the diffusion layer within the reagent of the working electrode, and the pulses are applied in a limited voltage window (or range) that is below the peak, diffusion-limited current. The readings below the peak are then used to determine glucose concentrations. With this technique, glucose concentrations can be determined relatively fast (e.g., within 5 seconds) and independently of the hematocrit levels of the fluid being analyzed.

Testing cartridge for an in vitro medical diagnostic device

The present disclosure relates to a removable assay cartridge containing a polymer body with channels for fluid movement for an in vitro medical diagnostic device. The device also includes a removable calibration fluid cartridge.

Analyte meter digital sample detection

An analyte meter is configured to digitally test for the presence of a test strip in the meter and for the presence of a sample in the test strip prior to activating an analog current measurement circuit of the meter. A test strip port connector having a plurality of contacts receives an inserted test strip in which the contacts electrically connect to electrodes on the test strip for digitally detecting both the presence of a test strip and a sample added to the test strip. A control circuit monitoring the contacts maintains the analyte meter in a low power mode until detecting both the test strip and the sample, whereupon the control circuit activates the meter and enables an analog analyte measurement circuit.

CARTRIDGES, KITS, AND METHODS FOR ENHANCED DETECTION AND QUANTIFICATION OF ANALYTES

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. The reader component may communicate with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

Method for distinguishing electrochemical sensors

A method for distinguishing between types of electrochemical test sensors in a meter is disclosed. The method comprises the acts of providing an electrochemical test sensor comprising an enzyme and a chemical additive, contacting the test sensor to the meter to form an electrical connection, applying a potential having a magnitude sufficient to initiate a redox reaction of the chemical additive, and determining which type of electrochemical test sensor is being used based on whether a predetermined signal has been generated after the potential has been applied. The meter is adapted to determine an analyte concentration in a fluid sample.

BLOOD GLUCOSE METER WITH LOW COST USER INTERFACE HAVING PROGRAMMED GRAPHIC INDICATORS

A blood glucose meter with a low cost user interface has a color glucose scale that is indexed by indicators programmed according to the user's blood glucose target range through a separating computing device due to the limited meter user interface. The color glucose scale is static and placed adjacent to the indicator such as by being molded into the housing, printed on the housing, or attached to the display. The low cost user interface has a monochrome segmented display with certain segments serving as a plurality of indicators. An indicator scaling module uses the target blood glucose range of the person with diabetes to calculate the blood glucose ranges for each indictor to index the color glucose measurement scale. The indicator scaling module can also assign attributes to the indicator such as flashing. The graphic representation of the user's blood glucose measurement aids in user interpretation. 1. A blood glucose meter with user interface having programmed graphic indicators , comprising:a meter housing having a strip port carried by the meter housing;a meter processor having meter memory carried inside the meter housing;a measurement module coupled to the strip port and connected to the meter processor;a meter communications port coupled to the meter processor; [ glucose scale comprises,', 'a first color area designating a user target range,', 'a second color area designating an above target range, and', 'a third color area designating a below target range,, 'a color glucose scale that is static and carried by the meter housing, the color'}, 'a monochrome segmented display coupled to the processor;', 'a plurality of numbers on the monochrome segmented display that display a blood glucose measurement numerically,', target range indicators on the monochrome segmented display located adjacent to the first color area of color glucose scale,', 'above target range indicators on the monochrome segmented display located adjacent to the second color area of color ...

BIOSENSOR AND METHOD FOR DETERMINING DIMENSION OF COUNTER ELECTRODE AND PROLONGING USAGE LIFETIME OF THE SAME

The present disclosure provides a biosensor for measuring a physiological signal representative of a physiological parameter associated with an analyte. The biosensor includes a working electrode and a counter electrode. The counter electrode including a silver and a silver halide having an initial amount, wherein the initial amount is determined by the following steps of defining a required consumption range of the silver halide during at least one of the measurement periods performed by the biosensor; and determining the initial amount based on a sum of an upper limit of the required consumption range and a buffer amount, so that a required replenishment amount range of the silver halide during the replenishment period is controlled to be sufficient to maintain an amount of the silver halide within a safe storage range.

Universal rapid diagnostic test reader with trans-visual sensitivity

A universal and standalone rapid diagnostics test reader is disclosed herein that includes: a set of control electronics, an illumination component, an imaging component, a housing component, a wireless communication component, a rapid diagnostics test component, a universal rapid diagnostics test tray, wherein the tray can hold at least one rapid diagnostics test component having a shape and a size in a fixed position relative to the imaging component and the illumination component, and wherein the reader can accommodate more than one different rapid diagnostics test component, while using the same universal rapid diagnostics test tray. A universal rapid diagnostics test tray for a reader is also disclosed that includes: a rapid diagnostics test component; a tray component that is designed to operatively couple with the reader, wherein the reader can analyze more than one different rapid diagnostics test components, while using the same universal rapid diagnostics test tray; and a security ...

Small Volume In Vitro Analyte Sensor

A sensor designed to determine the amount and concentration of analyte in a sample having a volume of less than about 1 muL. The sensor has a working electrode coated with a non-leachable redox mediator. The redox mediator acts as an electron transfer agent between the analyte and the electrode. In addition, a second electron transfer agent, such as an enzyme, can be added to facilitate the electrooxidation or electroreduction of the analyte. The redox mediator is typically a redox compound bound to a polymer. The preferred redox mediators are air-oxidizable. The amount of analyte can be determined by coulometry. One particular coulometric technique includes the measurement of the current between the working electrode and a counter or reference electrode at two or more times. The charge passed by this current to or from the analyte is correlated with the amount of analyte in the sample. Other electrochemical detection methods, such as amperometric, voltammetric, and potentiometric techniques ...

Analyte sensors with position adjustable transmit and/or receive components

An analyte sensor that detects an analyte via spectroscopic techniques using frequencies in the radio or microwave frequency range of the electromagnetic spectrum. The analyte sensor is configured to permit adjustment of the position(s) of one or more transmit components and/or the position(s) of one or more receive components. Adjusting position (or the like) as used in the description and claims includes changing an angle of the transmit component(s) and/or the receive component(s), and/or moving the transmit component(s) and/or the receive component(s) in one or more X, Y, Z directions, and/or changing a shape of the transmit component(s) and/or the receive component(s), and any combinations thereof.

Method for determining the concentration of an analyte in a liquid sample using small volume samples and fast test times

Analytes in a liquid sample are determined by methods utilizing sample volumes of up to 1.0 μl and test times from about 4 to about 9 seconds after detection of the sample. The methods are preferably performed using small test strips including a sample receiving chamber filled with the sample by capillary action.

Determination of blood glucose in a small volume and in a short test time using a chemical coating including binders and very short read potentials

Analytes in a liquid sample are determined by methods utilizing sample volumes of less than about 1.0 μl and test times within about eight seconds. The methods are preferably performed using small test strips including a sample receiving chamber filled with the sample by capillary action.

Biosensor, biosensor chip and biosensor device

A biosensor includes a working electrode 101 , a counter electrode 102 opposing the working electrode 101 , a working electrode terminal 103 and a working electrode reference terminal 10 connected to the working electrode 101 by wires, and a counter electrode terminal 104 connected to the counter electrode 102 by a wire. By employing a structure with at least three electrodes, it is possible to assay a target substance without being influenced by the line resistance on the working electrode side.

System and methods for determination of analyte concentration using time resolved amperometry

A method for determining a concentration of an analyte is disclosed. The method includes applying a potential excitation to a fluid sample containing an analyte and determining if a current decay curve associated with the fluid sample has entered an analyte depletion stage. The method also includes measuring a plurality of current values associated with the fluid sample during the analyte depletion stage and calculating an analyte concentration based on at least one of the plurality of current values.

Determining Analyte Concentrations in Biological Fluids with Abnormal Output Detection

A biosensor has an abnormal output detection system that determines whether an output signal from the redox reaction of an analyte has a normal or abnormal shape or configuration. The abnormal output detection system improves the accuracy and precision of the biosensor in determining whether an output signal has a shape or configuration that may not provide an accurate and/or precise analysis of a biological fluid. The biosensor generates an output signal in response to the redox reaction of the analyte. The biosensor normalizes the output signal and compares the normalized output signal with one or more control limits. The biosensor may generate an error signal when the normalized output signal is not within the control limits.

Biochemical measuring device

The invention provides a biochemical measuring device including: a measuring unit configured to measure a base current and a peak current; a time counting unit configured to count an elapsed time from the contact of a sensor electrode to a reference solution until the start of measurement of the base current; and a control unit, wherein the control unit acquires a concentration of a specific substance using the base current value when the elapsed time is equal to or longer than a stationarizing time, and when it is shorter than the stationarizing time, acquires the concentration of the specific substance using the stationary base current value measured by the measuring unit when the elapsed time is shorter than the stationarizing time instead of the current value of the base current.

Hand-held test meter with signal recovery block

A hand-held test meter (“HHTM”) for use with an analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing, an electrical signal receiving block, a signal recovery block and a microcontroller block, all of which are disposed in the housing. The electrical signal receiving block is configured to receive an electrical signal from an analytical test strip inserted in the HHTM that has been distorted into a distorted electrical signal. In addition, the signal recovery block and microcontroller block are configured to recover the electrical signal from the distorted electrical signal by generating a recovered electrical signal based on a predetermined recovered electrical signal frequency, a recovered electrical signal amplitude estimated from the distorted electrical signal, a recovered electrical signal offset estimated from distorted electrical signal and a recovered electrical signal phase determined using a least sum squares calculation.

Gated Voltammetry Devices

A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Gated voltammetric pulse sequences including multiple duty cycles of sequential excitations and relaxations may provide a shorter analysis time and/or improve the accuracy and/or precision of the analysis. The disclosed pulse sequences may reduce analysis errors arising from the hematocrit effect, variance in cap-gap volumes, non-steady-state conditions, mediator background, a single set of calibration constants, under-fill, and changes in the active ionizing agent content of the sensor strip.

Method for determining the concentration of an analyte in a liquid sample using small volume samples and fast test times

Analytes in a liquid sample are determined by methods utilizing sample volumes of up to 1.0 μl and test times from about 4 to about 9 seconds after detection of the sample. The methods are preferably performed using small test strips including a sample receiving chamber filled with the sample by capillary action.

Biological sample measuring device

This biological sample measuring device comprises a mounting portion ( 4 ) to which a biological sample measuring sensor ( 3 ) is mounted, a voltage application section ( 12 ) that applies voltage to a counter electrode ( 8 ) of the biological sample measuring sensor ( 3 ) mounted to the mounting portion ( 4 ), amplifiers ( 14 and 15 ) that are selectively connected to a working electrode ( 9 ) of the biological sample measuring sensor ( 3 ), and a determination section ( 19 ) that is connected to these amplifiers ( 14 and 15 ). The determination section ( 19 ) has a threshold determination section ( 21 ) that determines a voltage value obtained by voltage conversion of the current value of the working electrode ( 9 ), a same determination section ( 22 ) that selectively connects the amplifiers ( 14 and 15 ) to the working electrode ( 9 ) depending on the determination of the threshold determination section ( 21 ), and identifies the sample deposited on the biological sample measuring sensor ( 3 ) from the output of the selected amplifier ( 14 or 15 ), and an output section that outputs a measurement value corresponding to the identified sample.

Method and apparatus for assay of electrochemical properties

A method for monitoring a select analyte in a sample in an electrochemical system. The method includes applying to the electrochemical system a time-varying potential superimposed on a DC potential to generate a signal; and discerning from the signal a contribution from the select analyte by resolving an estimation equation based on a Faradaic signal component and a nonfaradaic signal component.

TEST STRIP EJECTOR FOR MEDICAL DEVICE

A test strip ejector system for receiving and ejecting a fluid testing medical device test strip includes a mechanism assembly supported by the device whereby user actuation of the mechanism assembly induces displacement of the test strip in at least a test strip ejection direction to eject the test strip. The mechanism assembly includes a power source and an electric motor such as a piezo-electric linear micro motor connected to the power source. The electric motor has an armature displaced when the electric motor is energized. A digital display/user interface is provided. Selection of an ejection function presented on the digital display/user interface initiates operation of the electric motor and displacement of the armature thereby displacing the test strip in the ejection direction. An operating system including a microprocessor is connected to the display/user interface. The microprocessor controls direction of operation and operating speed of the motor. 1. A test strip ejector system for receiving and ejecting a test strip of a fluid testing medical device , the system comprising: a power source; and', 'an electric motor connected to the power source, the electric motor having an armature displaced when the electric motor is energized; and, 'a mechanism assembly supported by the fluid testing medical device whereby user actuation of the mechanism assembly induces displacement of the test strip in at least a test strip ejection direction to eject the test strip, the mechanism assembly includinga digital display/user interface, selection of an ejection function presented on the digital display/user interface acting to initiate operation of the electric motor and displacement of the armature thereby displacing the test strip in the ejection direction.2. The test strip ejector system for receiving and ejecting a test strip of a fluid testing medical device of claim 1 , wherein the test strip is positioned in direct contact with the armature in a test strip test ...

Biosensor, biosensor chip and biosensor device

A biosensor includes a working electrode 101 , a counter electrode 102 opposing the working electrode 101 , a working electrode terminal 103 and a working electrode reference terminal 10 connected to the working electrode 101 by wires, and a counter electrode terminal 104 connected to the counter electrode 102 by a wire. By employing a structure with at least three electrodes, it is possible to assay a target substance without being influenced by the line resistance on the working electrode side.

System and method for quality assurance of a biosensor test strip

The present invention provides a test strip for measuring a signal of interest in a biological fluid when the test strip is mated to an appropriate test meter, wherein the test strip and the test meter include structures to verify the integrity of the test strip traces, to measure the parasitic resistance of the test strip traces, and to provide compensation in the voltage applied to the test strip to account for parasitic resistive losses in the test strip traces.

ABSOLUTE TEMPERATURE METHOD FOR DISPOSABLE GLUCOSE STRIP

A bio-fluid test strip includes a fluid receiving area and a contact pad area for interfacing with a fluid sensing device. The test strip includes a fluid sensing electrodes and a first temperature sensing resistor in the fluid receiving area. The test strip further includes a second temperature sensing resistor in the contact pad area. The first and second temperature sensing resistors together provide an indication of the temperature difference between the fluid sensing area and ambience.

Portable analytical device

A portable analytical device includes a housing, a measuring facility and a processor in the housing, and an electrical connector coupled to the housing and having one end electrically connected to the processor and an opposite end extending outwardly from the housing. The measuring facility is configured to analyze an optical or electrochemical change in the test element having received a liquid sample of the body fluid and to generate measuring values resulting from the analysis. A memory has stored therein software at least a portion of which is executable by the processor to process the measuring values to produce analytical measuring data taking into account calibration values. The electrical connector may be a male universal serial bus (USB) electrical connector, a Type-A USB electrical connector or a mini-USB electrical connector having electrical connections for electrical power, ground, data and ID.

METHOD FOR DETERMINING ANALYTE CONCENTRATION IN A SAMPLE TECHNICAL FIELD

A method for determining a concentration of an analyte in a fluidic sample is described. A sample is applied to a biosensor including an electrochemical cell having electrodes. A predetermined voltage waveform is applied during at least first and second time intervals. At least first and second current values are measured during the first and second time intervals, respectively. A turning point time is determined during the first time interval at which the measured first current values transition from a first to a second profile. The concentration of analyte in the sample is calculated based on determined turning point time and at least one measured current value. In another example, a physical characteristic of the sample is estimated based on measured current values. The concentration is calculated using a first or second model if the estimated physical characteristic of the sample is in a first or second range, respectively. 1. A method for determining a concentration of an analyte in a fluidic sample , the method comprising:applying the sample to a biosensor, the biosensor comprising an electrochemical cell having electrodes;applying a predetermined voltage waveform during at least a first time interval and a second time interval;measuring at least first current values during the first time interval and second current values during the second time interval;determining a turning point time during the first time interval at which the measured first current values transition from a first profile to a second profile; andcalculating the concentration of the analyte in the sample based on the determined turning point time and at least one current value of the measured first and second current values.2. The method of claim 1 , wherein the calculating step is based on the determined turning point time and at least one current value of the measured first current values and at least one current value of the measured second current values.3. The method of claim 1 , wherein ...

TEST ELEMENT ANALYSIS SYSTEM

A test element analysis system for an analytical examination of a sample, in particular of a body fluid, is disclosed. The test element analysis system comprises an evaluation device with a test element holder for positioning a test element containing the sample and a measuring device for measuring a change in a measuring zone of the test element, the change being characteristic for an analyte. The test element holder contains contact elements with contact surfaces which allow an electrical contact between contact surfaces of the test element and the contact surfaces of the test element holder. The contact surfaces of the contact elements of the test element holder are provided with an electrically conductive surface containing metallic ruthenium. 1. A test element analysis system for an analytical examination of a sample comprising:an evaluation device with a test element holder for positioning a test element containing the sample and a measuring device for measuring a change in a measuring zone of the test element, the change being characteristic for an analyte, wherein the test element holder contains contact elements with contact surfaces which allow an electrical contact between contact surfaces of the test element and the contact surfaces of the test element holder,wherein the contact surfaces of the contact elements of the test element holder are provided with an electrically conductive surface containing metallic ruthenium, wherein the test element holder comprises at least one metal part containing the contact elements with the contact surfaces, wherein the metal part is made of at least one conductive material other than ruthenium, wherein the conductive material, in the region of the contact elements, is fully or partially coated with ruthenium.2. The test element analysis system of claim 1 , where in the sample is a body fluid.3. The test element analysis system of claim 1 , wherein the conductive material comprises copper.4. The test element analysis ...

Analyte meter with operational range configuration technique

Described are techniques governing the glycemic ranges that are applied and governed in the meter so the user is not required to understand or know the editing rules in order to use or set up the meter. These guiding principles will come into effect each time the user chooses to edit the ranges. There will be appropriate warning messages to inform the user if the user does not set the ranges correctly.

REAL-TIME AND LABEL FREE ANALYZER FOR IN-VITRO AND IN-VIVO DETECTING THE SUSPICIOUS REGIONS TO CANCER

An apparatus for in-vivo measuring HOoxidation within a living tissue. The apparatus includes an electrochemical probe and an electrochemical stimulator-analyzer. The electrochemical probe includes a sensing part and a handle. The sensing part includes a working electrode, a counter electrode, and a reference electrode. The working electrode includes a first biocompatible conductive needle coated with a layer of vertically aligned multi-walled carbon nanotubes. The counter electrode includes a second biocompatible conductive needle. The reference electrode includes a third biocompatible conductive needle. The electrochemical stimulator-analyzer is configured to generate a set of electrical currents in a portion of the living tissue. 1. An apparatus for in-vivo measuring HOoxidation within a living tissue , comprising: [ a working electrode comprising a first biocompatible conductive needle coated with a layer of vertically aligned multi-walled carbon nanotubes (VAMWCNTs);', 'a counter electrode comprising a second biocompatible conductive needle; and', 'a reference electrode comprising a third biocompatible conductive needle; and, 'a sensing part, comprising, 'a handle, comprising an insertion part attached to the sensing part, the insertion part configured to be inserted the into a portion of the living tissue; and', generate a set of electrical currents in the portion of the living tissue by applying a set of electrical potentials to the electrochemical probe; and', 'record the set of electrical currents by measuring an electric current flowing from the counter electrode to the working electrode., 'an electrochemical stimulator-analyzer configured to], 'an electrochemical probe comprising2. The method of claim 1 , wherein electrochemical stimulator-analyzer is further configured to:apply the set of electrical potentials by applying a sweeping range of electrical potentials between −1 V and 1 V to the working electrode; andmeasure the electric currents at the ...

MULTIPLEXED MICROFLUIDIC PROTEOMIC PLATFORM

Disclosed herein is a microfluidic electrochemical device adapted for analysis of bone turnover markers in a fluidic sample, the microfluidic electrochemical device that can include: an electrochemical sensor layer comprising at least one work electrode having a surface modified for binding a bone turnover marker; and a microfluidic structure layer covering the electrochemical sensor layer such that a fluidic sample travelling in the microfluidic channels of the microfluidic structure layer come into contact with the electrode array. 1. A microfluidic electrochemical device adapted for analysis of bone turnover markers in a fluidic sample , the device comprisingan electrochemical sensor layer comprising at least one work electrode having a surface modified for binding a bone turnover marker, anda microfluidic structure layer covering the electrochemical sensor layer such that a fluidic sample travelling in microfluidic channels of the microfluidic structure layer come into contact with the electrode.2. The device according to claim 1 , wherein one or more bone turnover markers are used.3. The device according to claim 1 , wherein the surface is modified with any of cross-linkers and antibodies sensitive and specific for bone turnover markers.4. The device according to claim 1 , wherein the at least one work electrode comprises gold nanoparticles on their surface.5. The device according to claim 4 , wherein an antibody complex solution is covalently attached to the gold nanoparticles through the cross-linkers.6. The device according to claim 1 , wherein the device is adapted for receiving body fluid such as serum/whole blood samples as fluidic samples.7. The device according to claim 1 , wherein the microfluidic structure comprises a plurality of microfluidic channels so as to separately introduce the fluid sample and at least one of a wash buffer claim 1 , an antibody complex solution and an electrochemical detection probe into a detection chamber.8. The device ...

Glucometer system and method

The present application relates to an interactive glucose system that permits a user to customize and efficiently manage glucose levels. The system includes a glucose reader configured to interact with a test strip to generate a voltage representative of a glucose level within a blood sample. The voltage is transmitted to an electronic device to generate a glucose reading. The electronic device is configured to store and display data related to the glucose reading. The electronic device and the reader are independent and detachable from one another. The system permits for the use of multiple users to operate and test glucose levels from a single device.

SYSTEMS AND METHODS FOR AN ELECTROCHEMICAL TOTAL CHOLESTEROL TEST

An electrochemical test for total cholesterol includes a test strip for an electrochemical testing testing of a blood analyte which includes a first receiving port, the first receiving port for receiving a blood sample, the first receiving port at a first end of the test strip. The test strip further includes a first electrode and a second electrode, the first and second electrodes proximate to the first receiving port. The test strip further includes a first contact and a second contact, the first and second contacts at a second end of the test strip, the first and second contacts interconnected with the first and second electrodes, respectively. The test strip further includes cholesterol oxidase, located proximate to the first and the second electrode. The test strip further includes a mediator, located proximate to the first and the second electrode, wherein the cholesterol oxidase and the mediator interact with the blood sample and the first and second electrode to generate a measurable electrical event. 1. A test strip for electrochemical testing of a blood analyte , the test strip comprising:a first receiving port, the first receiving port for receiving a blood sample, the first receiving port at a first end of the test strip;a first electrode and a second electrode, the first and second electrodes proximate to the first receiving port;a first contact and a second contact, the first and second contacts at a second end of the test strip, the first and second contacts interconnected with the first and second electrodes, respectively;cholesterol oxidase, located proximate to the first and the second electrode;a mediator, located proximate to the first and the second electrode, wherein the cholesterol oxidase and the mediator interact with the blood sample and the first and second electrode to generate a measurable electrical event.2. The test strip of claim 1 , wherein one of the first and second electrodes includes the cholesterol oxidase and the mediator on a ...

IDENTIFYING IONIZABLE SPECIES WITH VOLTAMMETRIC DUTY CYCLES

A sensor system including devices and methods for determining the concentration of an analyte in a sample is described. Input signals including amperometric and voltammetric duty cycles of excitations and relaxations may provide a shorter analysis time and/or improve the accuracy and/or precision of the analysis. The disclosed system may reduce analysis errors, thus improving measurement performance, by adjusting the potential and/or scan rate in response to output currents obtained from voltammetric scans. The disclosed system also may determine the concentration of more than one ionizable species in the sample by adjusting the potential and/or scan rate in response to output currents obtained from voltammetric scans. The multiple, determined concentrations may be used to determine the concentration of multiple analytes or to correct the concentration determined for an analyte, thus improving the measurement performance of the system. 1. A method for identifying an ionizable species in a sample , comprising:applying to the sample an input signal comprising an acyclic scan, the acyclic scan including a forward excitation and a reverse excitation;detecting an output signal, the output signal including output currents responsive to the acyclic scan;identifying the ionizable species from the output currents responsive to the forward excitation of the acyclic scan.2. The method of claim 1 , further comprising taking derivatives of the output currents responsive to the forward excitation of the acyclic scan.3. The method of claim 2 , where the derivatives are sequential.4. The method of claim 2 , where the sign of the derivatives is used to identify the ionizable species.5. The method of claim 1 , further comprising identifying the ionizable species from a first ratio and a second ratio of the output currents when the second ratio is less than 1.6. The method of claim 5 , further comprising reducing a maximum potential of a subsequent acyclic scan in relation to the ...

CONNECTOR FOR CONNECTING BIO-SENSOR AND MEASURING INSTRUMENT THEREOF

Disclosed herein is a connector for connecting a biosensor and a measuring device thereof. The connector includes an insertion guide to prevent a connection electrode from being damaged due to a mis-insertion of the biosensor when the biosensor is inserted into the connector, and also may further include an integrated photo reflector for emitting and detecting an infrared ray to identify production lot information of the biosensor, so that production information of the biosensor may be simply opened, and as a result, the connector may be used as a connector for connecting the biosensor and the measuring device thereof. 1. A connector for electrically connecting a biosensor and a measuring device thereof and comprising one or more connection electrodes contacting an electrode of the biosensor , the connector comprising an insertion guide for guiding the biosensor such that the electrode of the biosensor contacts the connection electrodes of the connector , wherein the insertion guide is provided to an insertion portion , placed on the same surface as a surface on which the connection electrode is placed , and is shaped with one or more protrusion shapes such that a gap of the insertion portion is narrowed in a direction into which the biosensor is inserted , and provided at a height lower than a height between a surface on which the connection electrode is placed and a contact point of the connection electrode.2. The connector of claim 1 , wherein the insertion guide is provided to correspond to a change in thickness of the biosensor that is being inserted.3. The connector of claim 1 , further comprising an integrated photo reflector device for emitting and detecting an infrared ray to a surface facing a surface on which the connection electrode and the insertion guide are provided claim 1 , so as to identify a production lot information identification unit of the biosensor.4. The connector of claim 1 , wherein the biosensor comprises claim 1 ,an electrode unit ...

METAL-ION ELECTROCHEMICAL BIOSENSOR AND USE THEREOF

One aspect of the invention provides a method of determining metal ion levels in the patents due to corrosion and wear processes of the metallic implant in a human or veterinary patient. One embodiment provides a cost effective and patient driven early diagnostic method which has a potential application in orthopedics and dentistry. In one embodiment, the method includes the use of an electrochemical biosensor to detect metal ions or particles in a sample taken from a patient having a metallic implant. 1. A method for determining metal ion levels due to corrosion and wear (tribocorrosion) processes in a metallic implant present in a patient , comprising:adding a sample taken from the patient to an electrochemical cell; andmeasuring impedance at an electrode of the electrochemical cell to obtain a sample impedance value, wherein the sample impedance value is a measure of the presence of metal ions from the metallic implant in the sample and is indicative of the metal ion levels released to the patient body due to corrosion process of the metallic implant.2. The method of claim 1 , wherein the sample is selected from the group selected of a blood sample claim 1 , a urine sample and a synovial fluid sample.3. The method of claim 2 , wherein the sample is selected from the group consisting of a blood sample claim 2 , an urine sample and a synovial fluid sample.4. The method of claim 1 , wherein the implant comprises a metal component.5. The method of claim 1 , wherein metallic implant is selected from the group consisting of a dental implant claim 1 , a spinal implant claim 1 , a hip joint claim 1 , a knee joint claim 1 , an ankle joint and a shoulder joint.6. The method of claim 5 , wherein the metallic implant is a hip joint.7. The method of claim 1 , where the metal is selected from the group consisting of cobalt claim 1 , chromium claim 1 , molybdenum claim 1 , titanium claim 1 , vanadium claim 1 , aluminum and a combination thereof.8. The method of claim 1 , ...

MICROFLUIDIC CARTRIDGE AND READER DEVICE, SYSTEM, AND METHOD OF USE

Disposable microfluidic cartridges, potentiostat reader devices, systems, kits, and methods to determine the concentration of analyte reaction products in a patient's specimen, such as: blood, saliva, cerebrospinal fluid, joint fluid or tears. The microfluidic cartridges are disposable, paper-based strips comprising multiple assay layers, each layer comprising: a drop zone for receiving a patient specimen; a filter to remove contaminates, and/or isolate assay reactants; a hydrophilic microfluidic channel to direct movement of the specimen down the cartridge; a centered reaction chamber comprising impregnated enzymes and reagents to chemically react with the filtered specimen to produce an analyte; and a detector mechanism. Multiple analytes can be produced in parallel (e.g. one per layer), or sequentially along one layer. The detector mechanism utilizes electro-analytic methods to facilitate the reader device in quantifying each analyte, and each analyte concentration is wirelessly transmitted to an electronic computing device for storage in a patient's medical record. 1. A disposable microfluidic cartridge device for detecting and quantifying the amount of an analyte in a fluid specimen , wherein the microfluidic cartridge device comprises:a. a backing strip providing structural support to one or more assay layers; i. a drop zone for receiving a droplet of a patient specimen;', 'ii. a filter configurable to remove contaminates, and/or to isolate assay reactants;', 'iii. a straight hydrophilic microfluidic channel extending from the filter to a reaction chamber, and from the reaction chamber to a detector mechanism;', 'iv. a reaction chamber comprising impregnated enzymes and reagents to chemically react with the assay reactants to produce one or more analyte reaction products; and,', 'v. a detector mechanism for facilitating a reader device to detect and/or quantify the amount or concentration of the one or more analyte reaction products using electro-analytic ...

EXTENDED RANGE IMMUNOASSAY DEVICES WITH IMMUNOSENSOR AND MAGNETIC IMMUNOSENSOR

The present invention relates to systems and methods that utilize a combination of immunoassay and magnetic immunoassay techniques to detect an analyte within an extended range of specified concentrations. In particular, a device includes a housing, a heterogeneous surface capture immunosensor within the housing and configured to generate a first signal indicative of the concentration of the analyte in an upper concentration range, and a homogeneous magnetic bead capture immunosensor within the housing and configured to generate a second signal indicative of the concentration of the analyte in a lower concentration range. 1. A sensor chip comprising:a non-conductive substrate;a first sensor for an analyte; anda second sensor for the analyte,wherein the non-conductive substrate is planar, and comprises a top surface and a bottom surface, the top surface forming a base for the first sensor and the second sensor,wherein the first sensor is a heterogeneous surface capture immunosensor comprising a conductive layer deposited on the non-conductive substrate, and a capture biomolecule immobilized on or near at least a portion the conductive layer, andwherein the second sensor is a homogeneous magnetic bead capture immunosensor comprising a second microelectrode, and a magnetic element.2. The sensor chip of claim 1 , wherein the first sensor and the second sensor are spaced at least 0.3 mm apart on the non-conductive substrate.3. The sensor chip of claim 1 , wherein the capture biomolecule is coated onto microspheres deposited on the at least the portion of the conductive layer.4. The sensor chip of claim 1 , wherein the capture biomolecule is an antibody.5. The sensor chip of claim 4 , wherein the antibody is an anti-troponin I (TnI) antibody or an anti-cardiac troponin I (cTnI) antibody.6. The sensor chip of claim 1 , wherein the at least the portion of the conductive layer is surrounded by a containment structure.7. The sensor chip of claim 1 , wherein the magnetic ...

MEASUREMENT APPARATUS, AND METHOD FOR OPERATING MEASUREMENT APPARATUS

A measurement apparatus to measure a physical quantity related to a measurement target by use of a sensor, comprising: an apparatus enclosure; a control unit to be electrically connected to the sensor; and a moving member including a sensor holding unit to hold the sensor, the moving member being movable to protrude the sensor holding unit outwardly of the apparatus enclosure and further including a conductive member to electrically connect the sensor to the control unit.

Smart Sensor Ports and Methods of Using Same

The present disclosure provides an orientation-nonspecific sensor port for use in analyte meters designed to detect and quantify analyte levels in a fluid sample along with methods of using the same. The present disclosure also provides compositions and methods for facilitating the correct insertion of a sensor into a corresponding analyte meter. 1102-. (canceled)103. A method for determining a concentration of an analyte in a fluid sample , the method comprising:positioning a sensor in a sensor port of an analyte meter, wherein the sensor port comprises a first electrode contact and a second electrode contact,detecting, by the analyte meter, an orientation of the sensor upon positioning of the sensor in the sensor port,configuring, by the analyte meter, one of the first electrode contact and the second electrode contact as a working electrode contact;depositing a fluid sample on a the sensor; anddetermining the concentration of the analyte using the sensor.104. The method of claim 103 , wherein each of the first electrode contact and the second electrode contact is also capable of being configured as a reference and/or counter electrode contact claim 103 , and based on the orientation claim 103 , the analyte meter configures the first electrode contact as a working electrode contact and the second electrode contact as a reference and/or counter electrode contact.105. The method of claim 103 , wherein the sensor port is configured to receive a sensor comprising opposing working and reference and/or counter electrodes or coplanar working and reference and/or counter electrodes.106. The method of claim 103 , wherein the analyte is glucose or ketone bodies.107. The method of claim 103 , wherein the analyte meter is activated upon positioning of the sensor in the sensor port.108. The method of claim 107 , wherein the sensor comprises a turn-on/selection monitor claim 107 , the sensor port comprises a turn-on/selection contact claim 107 , and the turn-on/selection ...

PORTABLE ANALYTICAL DEVICE

A portable analytical device includes a housing, a measuring facility and a processor in the housing, and an electrical connector having one end electrically connected to the processor and an opposite end operatively connectable to an external electronic device. The measuring facility is configured to analyze a change in a test element resulting from receipt thereon of a liquid sample of a body fluid and to generate measuring values resulting from the analysis. A memory has instructions stored therein executable by the processor to process the measuring values to generate analytical measuring data based thereon and to output the generated analytical measuring data onto the electrical connector. The analytical device does not include an intrinsic user interface for displaying the generated analytical measuring data. Display of the generated analytical measuring data is implemented exclusively by the external electronic device having received the generated analytical measuring data via the electrical connector. 122.-. (canceled)23. An analytical device for analysis of a medically significant component of a body fluid , comprising:a device housing defining an opening therein,a measuring facility arranged inside the device housing configured to receive a test element via the housing opening, the measuring facility configured to analyze a change in the test element resulting from receipt thereon of a liquid sample of the body fluid and to generate measuring values resulting from the analysis,a processor carried by the device housing,an electrical connector carried by the device housing and having one end electrically connected to the processor, the electrical connector having an opposite end configured to operatively connect to an external electronic device, anda memory carried by the device housing and having instructions stored therein which, when executed by the processor, cause the processor to generate analytical measuring data based on the measuring values and to ...

Electronic device for measuring blood sugar

An operating method of an electronic device may include detecting that a strap with a blood sugar measuring device has been connected to the electronic device, receiving blood sugar related data from the blood sugar measuring device, and executing a health application based on the received data.

CONTROL CIRCUIT FOR USE WITH A FOUR TERMINAL SENSOR, AND MEASUREMENT SYSTEM INCLUDING SUCH A CONTROL CIRCUIT

A control circuit for use with a four terminal sensor, the sensor having first and second drive terminals and first and second measurement terminals, the control circuit arranged to drive at least one of the first and second drive terminals with an excitation signal, to sense a voltage difference between the first and second measurement terminals, and control the excitation signal such that the voltage difference between the first and second measurement terminals is within a target range of voltages, and wherein the control circuit includes N poles in its transfer characteristic and N−1 zeros in its transfer characteristic such that when a loop gain falls to unity the phase shift around a closed loop is not substantially 2π radians or a multiple thereof, where N is greater than 1. 1. (canceled)2. A control circuit configured to couple to a biological sensor , the control circuit comprising:an excitation output node configured to provide current for a variable impedance of the biological sensor;a sensor input configured to receive a signal indicative of a voltage across the variable impedance;an amplifier configured to receive the signal and to adjust an excitation voltage at the excitation output node based on a comparison of the signal and a reference voltage.wherein a feedback path of the amplifier is configured to provide a zero of a transfer characteristic of the control circuit at a frequency where the gain of the control circuit is greater than unity gain.3. The control circuit of claim 2 , wherein the transfer characteristic of the control circuit includes N poles and N−1 zeros; andwherein N is an integer greater than 2.4. The control circuit of claim 3 , wherein one of the N poles is implemented using an integrator.5. The control circuit of claim 3 , wherein a pole and zero pair of the N poles and the N−1 zeros is provided by a series combination of a capacitor and a resistor in a feedback loop of an operational amplifier.6. The control circuit of claim 2 , ...

HAND-HELD TEST METER WITH FLUID INGRESS DETECTION CIRCUIT

A hand-held test meter (“HHTM”) for use with analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing, a strip port connector disposed at least partially within the housing, a micro-controller disposed in the housing, a voltage supply disposed in the housing, a fluid ingress detection circuit block (“FRIDCB”) disposed in the housing and includes a paired signal and ground trace, and a ground-reference. A portion of the signal trace and ground trace are separated by a predetermined distance. The signal trace is electrically connected to the voltage supply and to the micro-controller and the ground trace is electrically connected to the ground-reference. With no ingress fluid, the signal trace is electrically isolated from the ground trace. The FRIDCB generates an output signal to the micro-controller that is dependent on fluid ingress into the meter housing, thus providing for detection of fluid ingress. 1. A hand-held test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample , the hand-held test meter comprising:a housing;a strip port connector disposed at least partially within the housing;a micro-controller disposed in the housing;a voltage supply disposed in the housing;a fluid ingress detection circuit block disposed in the housing and including:at least one paired signal trace and ground trace; anda ground-reference,wherein at least a portion of the at least one signal trace and at least a portion of the at least one ground trace are separated by a predetermined distance;wherein the at least one signal trace is electrically connected to the voltage supply and to the micro-controller;wherein the ground trace is electrically connected to the ground-reference; andwherein the in the absence of ingress fluid, the signal trace of the at least one paired signal trace is electrically isolated from the ground trace.2. The hand-held test meter of wherein the fluid ingress ...

SALIVA GLUCOSE MEASUREMENT DEVICES AND METHODS

Devices and methods capable of detecting glucose in saliva (FIG. ). The devices feature a sensor having a substrate containing electrodes and one or more reagents on the electrodes. A detection device is operably coupled with the sensor to detect glucose based on measurement of an electrical parameter when electricity is applied to the electrode. 1. A device configured to detect glucose in saliva , comprising:a sensor having a substrate containing electrodes and one or more glucose-detection reagents on said electrodes; anda detection device operably coupled with said sensor to detect said glucose based on measurement of an electrical parameter when electricity is applied to said electrodes.2. The sensor device of claim 1 , wherein said one or more reagents comprise glucose dehydrogenase (GDH) and ferricyanide in 1×PBS buffer.3. The sensor device of claim 1 , further including a sulfonated tetrafluoroethylene-based fluoropolymer-copolymer coating or mesoporous carbon coating on one or more of the electrodes.4. The sensor device of claim 2 , wherein said reagents are in dry form.5. The sensor of claim 1 , wherein said one or more reagents comprise glucose dehydrogenase flavine-adenine dinucleotide (GDH-FAD) and ferricyanide in 1×PBS buffer.6. A method of detecting a blood glucose level using saliva claim 1 , the method comprising:contacting a sensor containing electrodes and one or more glucose-detection reagents on said electrodes with saliva; andenergizing said electrodes such that a measurement of an electrical parameter indicative of an amount of glucose in said saliva is produced and measured.7. The method of claim 6 , wherein said one or more reagents comprise glucose dehydrogenase (GDH) and ferricyanide in 1×PBS buffer.8. The method of claim 6 , wherein said one or more reagents comprise glucose dehydrogenase flavine-adenine dinucleotide (GDH-FAD) and ferricyanide in 1×PBS buffer.9. A method of monitoring a glucose level against a desired range in a patient ...

Calibration material delivery devices and methods

A device includes: a first portion configured to be grasped by the hand of the user, and a second portion defining a reservoir containing a control material, wherein the control material contains a target analyte in a known or predetermined concentration. A method of verifying the accuracy of an analyte monitoring device includes receiving control information, receiving a fluid sample, identifying the fluid sample as a control solution, and analyzing the control solution.

SYSTEMS, DEVICES, AND METHODS FOR MEASURING WHOLE BLOOD HEMATOCRIT BASED ON INITIAL FILL VELOCITY

Methods for determining the hematocrit of a blood sample, and devices and systems used in conjunction with the same. The hematocrit value can be determined on its own, and further, it can be further used to determine a concentration of an analyte in a sample. In one exemplary embodiment of a method for determining the hematocrit value in a blood sample, a volume of blood is provided in a sample analyzing device having a working and a counter electrode. An electric potential is applied between the electrodes and an initial fill velocity of the sample into the device is calculated. The hematocrit of the blood, as well as a concentration of an analyte in view of the initial fill velocity can then be determined. Systems and devices that take advantage of the use of an initial fill velocity to determine hematocrit levels and make analyte concentration determinations are also provided. 1. A method for determining a concentration of an analyte in a sample , the method comprising:providing a sample including an analyte to a sample analyzing device having a working electrode and a counter electrode;applying an electric potential between the working electrode and the counter electrode;determining an initial fill velocity of the sample; andcalculating a concentration of the analyte in view of the initial fill velocity.2. The method of claim 1 , wherein determining an initial fill velocity further comprises:measuring an initial current after applying the electric potential;determining a level of hematocrit in the sample; andreversing the electric potential between the working electrode and the counter electrode.3. The method of claim 2 , wherein calculating the concentration of the analyte further comprises computing the concentration based on the determined level of hematocrit.4. The method of claim 3 , further comprising measuring a change in current over a period of time following reversing the electric potential claim 3 , wherein calculating a concentration of the analyte ...

SYSTEM FOR MEASURING CHARGES PROPAGATING THROUGH A BIOLOGICAL OBJECT

Disclosed is a system for measuring electrical charges propagating through a biological object. The system includes an implantable medical device inserted into the biological object, an electronic implant attached to the implantable medical device for measuring, processing and communicating electrical charges, at least one transponder configured on the implantable medical device to convert mechanical waves into electrical charges, wherein the electrical charges propagate through the biological object to be received by the electronic implant; and an external electronic hub device for providing electrical charges to influence the biological object. The external electronic hub device includes a controller, a frequency generator, a resonator, a filter unit, and an electrode. The electronic implant includes an arrangement of sub-circuits, an energy convertor, an amplifier, an analog/digital converting logic circuit, and a modulator. The amplifier receives the amplified bio-electrical charges while suppressing electrical influence, further the amplifier creates an amplified analog value representing the bio-electrical charges. 1. A system for measuring charges propagating through a biological object , the system comprising:an implantable medical device inserted into the biological object;an electronic implant attached to the implantable medical device for measuring, processing and communicating electrical charges;at least one transponder configured on the implantable medical device to convert mechanical waves into electrical charges, wherein the electrical charges propagate through the biological object to be received by the electronic implant; and a controller contactlessly power and communicates data with the electronic implant;', 'a frequency generator for generating alternating charges;', 'a resonator for resonating and reflecting data modulation;', 'a filter unit for mixing data received from the controller with the alternating charges and further the filter unit ...

Analyte sensors, systems, testing apparatus and manufacturing methods

In some aspects, an analyte sensor is provided for detecting an analyte concentration level in a bio-fluid sample. The analyte sensor may include one or more conductors received in a hollow portion of a hollow member. The first conductor may be made, at least in part, of a semiconductor material and an active region may be provided in contact with at least the first conductor. The analyte sensor may, in one aspect, include a lancet and an integrated sensor. Manufacturing methods and apparatus and systems utilizing the analyte sensors are provided, as are numerous other aspects.

ELECTRODE AND MANUFACTURING METHOD THEREOF, ENZYME SENSOR, GLUCOSE SENSOR AND IN-VIVO COMPONENT MEASURING DEVICE

In a hydrogen peroxide electrode used as a working electrode of an enzyme sensor , an intermediate layer containing particles and a retentive substance for holding the particles inside the retentive substance are provided on a substrate , and an electrode layer is provided on the intermediate layer . In this way, according to the hydrogen peroxide electrode , hydrogen peroxide can be detected with high sensitivity even when an applied voltage that is not susceptible to interference by interference substances present in the living body is used. 1. An electrode comprising:an intermediate layer being disposed on a substrate and including particles and a retentive substance for holding the particles inside the retentive substance; andan electrode layer being disposed on the intermediate layer and adapted to electrolyze hydrogen peroxide and flow an electrical current in contact with the hydrogen peroxide.2. The electrode according to claim 1 , wherein the electrode layer includes platinum.3. The electrode according to claim 1 , wherein a layer including particles and a layer including the retentive substance are laminated in the intermediate layer.4. The electrode according to claim 1 , wherein the particles are nanoparticles or microparticles.5. The electrode according to claim 1 , wherein the particles are porous particles.6. The electrode according to claim 1 , wherein the particles are nonconductive particles.7. The electrode according to claim 1 , wherein the retentive substance is a hydrophilic polymer substance.8. The electrode according to claim 7 , wherein the hydrophilic polymer substance is polyvinyl alcohol.9. The electrode according to claim 1 , wherein a hydrogen peroxide selective permeation film is not provided on the electrode layer.10. A glucose sensor comprising:a substrate;{'claim-ref': {'@idref': 'CLM-00001', 'claim 1'}, 'the electrode according to arranged on the substrate; and'}oxidase immobilized on a surface of the electrode.11. A glucose sensor ...

Blood glucose measuring device and method, and electronic device including blood glucose measuring module

A method and device for measuring blood glucose are provided. The device includes a strip receiving part having a plurality of pins therein, the pins being arranged in such a manner that at least one of the pins contacts at least one electrode formed in a blood glucose measurement strip when the blood glucose measurement strip is inserted into the strip receiving part; and a controller configured to identify a type of the blood glucose measurement strip inserted into the strip receiving part and to control application of a testing voltage configured in response to the identified type of the blood glucose measurement strip to each pin of the strip receiving part.

MEASURING DEVICE AND METHODS FOR USE THEREWITH

The ability to switch at will between amperometric measurements and potentiometric measurements provides great flexibility in performing analyses of unknowns. Apparatus and methods can provide such switching to collect data from an electrochemical cell. The cell may contain a reagent disposed to measure glucose in human blood. 1. An apparatus for use with a reaction cell having a first electrode and a second electrode , the apparatus comprising:a voltage or current source providing a controllable voltage or current to the first electrode;a voltage sensor sensing voltage provided at the first electrode;an amplifier;switch means switchable between first and second positions, said switch means in said first position disposing the amplifier to measure current through the second electrode, thereby measuring current through the reaction cell, said switch means in said second position disposing the amplifier to measure voltage present at the second electrode.2. The apparatus of claim 1 , wherein the switch means comprises first claim 1 , second claim 1 , and third analog switches claim 1 , the first analog switch connecting the second electrode and an inverting input of the amplifier claim 1 , the second analog switch connecting the second electrode and a non-inverting input of the amplifier claim 1 , the third analog switch connecting the non-inverting input of the amplifier and a reference voltage claim 1 , the first position defined by the first and third switches being closed and the second switch being open claim 1 , the second position defined by the first and third switches being open and the second switch being closed.3. A method for use in a test equipment apparatus having an electrochemical cell disposed to receive a bodily fluid of a human user claim 1 , the apparatus comprising electronic circuitry claim 1 , the method comprising the steps of:under automatic control of the electronic circuitry, allowing electrical current to flow through the cell by means of a ...

Method of operation of a meter

The method of operation of a meter includes placing a sample on a test strip, assigning a first electrode of the test strip to be a counter electrode, applying a first signal to the test strip during a first period of time, assigning a second electrode of the test strip to be the counter electrode, applying a second signal to the test strip to measure the concentration of an analyte in the sample. 1. A method of operation of a meter to measure a response of a sample on a reaction chamber of a test strip , comprising:assigning a first electrode of the test strip to be a counter electrode;applying a first signal to a working electrode of the test strip during a first period of time;assigning a second electrode of the test strip to be the counter electrode;applying a second signal to the working electrode of the test strip during a second period of time; andmeasuring the response during the second period of time.2. The method of claim 1 , wherein assigning the first electrode of the test strip to be the counter electrode and assigning the second electrode of the test strip to be the counter electrode is performed using at least one switch of the meter.3. The method of claim 1 , further comprising assigning the first electrode of the test strip to be a reference electrode before applying the second signal to the working electrode of the test strip during the second period of time.4. The method of claim 1 , further comprising assigning the second electrode of the test strip to be a reference electrode before applying the first signal to the working electrode of the test strip during the first period of time.5. The method of claim 1 , wherein said the response is measuring a current across the working electrode and the second electrode.6. The method of claim 1 , wherein the test strip comprises at least four electrodes.7. The method of claim 6 , wherein assigning a third electrode of the test strip to be the reference electrode during the first period and second period of ...

MICRO BIOSENSOR AND MEASURING METHOD THEREOF

The present invention provides a measuring method for prolonging a usage lifetime of the micro biosensor to measure a physiological signal associated with an analyte. The micro biosensor includes a working electrode, a counter electrode including silver and a silver halide having an initial amount, and an auxiliary electrode. The method includes cyclic steps of: applying a measurement voltage to drive the working electrode to measure the physiological signal, where the silver halide is consumed by a consumption amount; stopping applying the measurement voltage; and whenever the physiological parameter is obtained, applying a replenishment voltage between the counter electrode and the auxiliary electrode to drive the counter electrode, thereby the silver halide of a replenishment amount being replenished to the counter electrode, wherein a guarding value of a sum of the replenishment amount and the initial amount subtracting the consumption amount is controlled within a range of the initial amount plus or minus a specific value. 1. A method of measuring an analyte using a biosensor for prolonging a usage lifetime of the biosensor implanted subcutaneously to measure a physiological signal representative of a physiological parameter associated with the analyte in a biofluid , the biosensor comprising a working electrode , a counter electrode and an auxiliary electrode , the working electrode being at least partially covered by a chemical reagent configured to react with the analyte , the counter electrode having a silver and a silver halide , the method comprising the following steps of: i. applying a measurement potential difference across the working electrode and the counter electrode so that the working electrode has a higher voltage level than that of the counter electrode during a measurement period, for causing a first oxidation reaction to occur on the working electrode having an electrochemical reaction with the chemical reagent and the analyte to output a ...

METHOD FOR ESTIMATING DISTRIBUTION OF SAMPLE

The present invention relates to a method for estimating a distribution of a sample flowed from a first electrode toward a second electrode of an electrochemical test strip. A working voltage is provided between the first electrode and the second electrode for obtaining a first and a second currents, where a ratio of the first current to the second current is applied to estimate the distribution of the sample on the first and the second electrodes and an effectiveness of a measurement of a target analyte of the sample. 1. A determining method for a distribution of the target sample in a sensor consisting of a first electrode and a second electrode , each of which is coated with a reagent layer , and a concentration of an analyte in the target sample , comprising the steps of:(a) providing a target sample flowing from the first electrode to the second electrode;(b) immediately providing a switching circuit having a first configuration for applying a first DC voltage with a voltage value across the first electrode and the second electrode for a first duration to make a potential of the first electrode higher than a potential of the second electrode, wherein the first electrode functions as a working electrode to generate a first Cottrell current, the second electrode functions as a counter electrode, and the target sample flows from the working electrode to the counter electrode;(c) removing the first DC voltage for a first removing duration;(d) switching the switching circuit to have a second configuration for applying a second DC voltage with a voltage value across the first electrode and the second electrode for a second duration to make the potential of the second electrode higher than the potential of the first electrode, wherein the second electrode functions as the working electrode to generate a second Cottrell current, the first electrode functions as the counter electrode, and the respective voltage values of the first and the second DC voltages are equal;(e ...

SYSTEM AND METHOD FOR COMPENSATING SAMPLE-RELATED MEASUREMENTS BASED ON POLARIZATION EFFECTS OF TEST STRIPS

A system and a method for correcting an analyte concentration measurement taken by a test strip is described herein. The test strip includes at least two spaced apart electrodes defining an electrochemical cell or reaction chamber. An initial polarization parameter of the test strip is determined at the time of test strip manufacture and a testing polarization parameter is determined at the time of testing. A resulting correction factor is then determined based on the initial and testing polarization parameters. The correction parameter can be applied to a measured analyte concentration in order to correct the measured analyte concentration. 1. A method for determining an analyte concentration of a sample fluid applied to a test strip , the test strip comprising at least two electrodes in spaced relation and defining a reaction chamber , the method comprising:determining an initial polarization parameter of the test strip at a time of test strip manufacture;determining a testing polarization parameter of the test strip at a time of testing;determining a correction parameter of the test strip based on the initial polarization parameter and the testing polarization parameter;measuring an initial analyte concentration; andapplying the correction parameter to the initial analyte concentration to produce a corrected analyte concentration.2. The method of claim 1 , wherein the at least two electrodes comprise carbon screened electrodes to which an electrical potential can be applied in order to measure an analyte concentration.3. The method of claim 1 , in which measuring the initial analyte concentration comprises:applying an electrical test potential between the at least two electrodes;measuring a resulting current output in response to the applied electrical test potential; anddetermining the initial analyte concentration based on the current output.4. The method of claim 1 , wherein a polarization parameter is determined by applying a first potential between the at ...

TEST STRIP EJECTOR FOR MEDICAL DEVICE

A system for receiving and ejecting a fluid testing device test strip includes a strip connector having first and second guide rails, and divider walls each having a channel. A sled has first and second legs connected to a cross member. Each leg has a contact leg extending inwardly from a chamfered end. The first and second legs when positioned parallel to the guide rails have the contact leg captured in the divider wall channels retaining the sled in sliding contact with the guide rails for motions in loading and ejection directions. A mechanism assembly is movably connected to the fluid testing device. The cross member is coupled so operation in a first direction displaces the sled in the loading direction positioning the sled in a test strip test position, and opposite operation positions the contact legs in direct contact with and ejects the test strip. 1. A test strip ejector system for receiving and ejecting a test strip of a fluid testing medical device , the system comprising:a strip connector including first and second guide rails and first and second divider walls positioned between the first and second guide rails, each of the first and second divider walls having a channel;a sled having parallel first and second legs connected to a cross member separating the first and second legs by an initial spacing, each of the legs having a chamfered end and a contact leg extending inwardly from the chamfered end, the legs initially displaced outwardly with respect to the initial spacing with the chamfered end positioned parallel with respect to the guide rails such that the contact leg of each of the first and second legs is received in the channel of one of the first or second divider walls, the first and second legs subsequently rotated to an orientation parallel to the first and second guide rails allowing the legs to spring back to the initial spacing thereby capturing the contact leg of each of the first and second legs in the channel to retain the sled in ...

ALL-ELECTRONIC HIGH-THROUGHPUT ANALYTE DETECTION SYSTEM

An all-electronic high-throughput detection system can perform multiple detections of one or more analyte in parallel. The detection system is modular, and can be easily integrated with existing microtiter plate technologies, automated test equipments and lab workflows (e.g., sample handling/distribution systems). The detection system includes multiple sensing modules that can perform separate analyte detection. A sensing module includes a platform configured to couple to a sample well. The sensing module also includes a sensor coupled to the platform. The sensing module further includes a first electrode coupled to the platform. The first electrode is configured to electrically connect with the sensor via a feedback circuit. The feedback circuit is configured to provide a feedback signal via the first electrode to a sample received in the sample well, the feedback signal based on a potential of the received sample detected via a second electrode. 124-. (canceled)25. A method of detecting analytes comprising:detecting a potential associated with a sample received in a sample well by a first electrode;generating a feedback signal by a feedback circuit electrically coupled to the first electrode; and{'claim-text': 'wherein the first, the second and the third electrodes are coupled to a platform configured to receive the sample well.', '#text': 'providing the feedback signal to the sample via a second electrode, the feedback signal configured to provide excitation control of redox species in the sample at a third electrode,'}26. The method in claim 25 , wherein the feedback circuit is configured to detect a current from the sample via the third electrode claim 25 , the detected current indicative of an analyte in the sample.27. The method in claim 26 , wherein the first electrode and the third electrode are located on a sensor.28. The method in claim 27 , wherein the platform comprises an electromagnetic shield configured to shield the sensor by attenuating external ...

Auxiliary Electrodes and Methods for Using and Manufacturing the Same

An electrochemical cell includes a plurality of working electrode zones disposed, and defining a pattern, on a surface of the cell and at least one auxiliary electrode disposed on the surface. The auxiliary electrode may have a defined interfacial potential. 1. An electrochemical cell for performing electrochemical analysis , the electrochemical cell comprising:a plurality of working electrode zones disposed, and defining a pattern, on a surface of the cell; and{'claim-text': 'wherein the at least one auxiliary electrode is disposed at an approximate equal distance from at least two of the plurality of working electrode zones.', '#text': 'at least one auxiliary electrode disposed on the surface, the at least one auxiliary electrode having a redox couple confined to its surface,'}2. The electrochemical cell of claim 1 , wherein claim 1 , during the electrochemical analysis claim 1 , the auxiliary electrode has a potential defined by the redox couple.3. The electrochemical cell of claim 2 , wherein the potential ranges from approximately 0.1 volts (V) to approximately 3.0 V.4. The electrochemical cell of claim 3 , wherein the potential is approximately 0.22 V.5. The electrochemical cell of claim 1 , wherein the pattern minimizes a number of working electrode zones that are adjacent to one another for each of the working electrode zones among the plurality of working electrode zones.6. The electrochemical cell of claim 1 , wherein the pattern is configured to provide uniform mass transport of a substance to each of the plurality of working electrode zones under conditions of rotational shaking.7. The electrochemical cell of claim 1 , wherein each of the plurality of working electrode zones defines a circular shape having surface area that defines a circle.8. The electrochemical cell of claim 7 , wherein:the at least one auxiliary electrode is disposed at an approximate center of the electrochemical cell,the plurality of working electrode zones includes ten working ...

Systems and methods for facilitating fluid flow during enhanced detection and quantification of analytes

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. The reader component may communicate with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

Cartridges, collectors, kits, and methods for enhanced detection and quantification of analytes in collected fluid samples

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. The reader component may communicate with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

LIQUID SAMPLE MEASURING SYSTEM AND MEASURING DEVICE

A liquid sample measuring system includes a measuring device including a measuring section which measures biological information from liquid sample of a living subject within a housing in which a biosensor, on which the liquid sample of the biological body is deposited, is detachably mounted and a movement measuring section which measures movement information of the housing within the housing, and an administrating device including a movement determining section which determines whether or not a degree of the movement of the housing is within an allowable range by analyzing the movement information received from the measuring device. 114-. (canceled)15. A liquid sample measuring device , comprising:a housing to which a biosensor on which a liquid sample of a living subject is deposited is detachably mounted;a measuring section configured to measure biological information from the liquid sample of the living subject, the measuring section disposed inside of the housing;a movement measuring section configured to measure movement information of the housing, the movement measuring section disposed inside the housing;a recording section configured to record identification information including at least one of identification of a measurer, identification of a subject person, and identification of the biosensor as measuring administration data;an input section to which the identification information and the movement instruction from the measurer are inputted;a display section configured to display the measuring administration data and information for the measurer;a control section configured to calculate consumption of the biosensor by extracting the identification of the biosensor from the measuring administration data.16. The liquid sample measuring device according to claim 15 , wherein:the measuring administration data includes at least one of a time of mounting the biosensor, a time of the sample deposition, a time of starting measuring and a time of ending measuring. ...

BIOCAPACITIVE BOD SENSOR

There is provided a biofilm capacitance microbial electrochemical cell (MEC) sensor to measure organic carbon in water and wastewater rapidly and accurately, represented by the 5-day biochemical oxygen demand (BOD). The MEC runs at charging (open circuit) and discharging (close circuit) conditions alternately to improve the sensitivity, response time and accuracy. The detectable BODconcentrations with the biofilm-capacitance MEC range from 5 to 250 mg/L (R>0.9). The MEC sensor enables BODmeasurements at every 2 minutes (1 minute charging and 1 minute discharging), indicating semi-continuous quantification of organic carbon in water and wastewater. 1. A biocapacitive BOD sensor comprising:a microbial electrochemical cell (MEC) having a biofilm anode and a biofilm cathode, the biofilm anode working as a capacitor; anda reference electrode optionally inserted into the cell to fix the anode potential;wherein the MEC is run at charging, open circuit, and discharging, close circuit, conditions alternately; andwherein bio-capacitance of the biofilm anode indicates organic carbon concentration.2. Use of the biocapacitive BOD sensor of for sensing other organic compounds including organic carbon claim 1 , non-biodegradable compounds claim 1 , or toxics.3. Use of the biocapacitive BOD sensor of by power suppliers to measure the organic carbon concentration in water.4. The biocapacitive BOD sensor of comprising more than one MEC stacked in serial or parallel to power the BOD sensor.5. A system comprising the biocapacitive BOD sensor of integrated with one or more other devices to improve biodegradability or reliability between cumulative coulombs and oxygen demand.6. The BOD sensor of wherein the biofilm anode has ARB as the dominant microorganism.7. The BOD sensor of further comprising a separator partitioning the anode and the cathode.8. The BOD sensor of wherein electrons are transferred to biofilm anodes catalyzed by ARB in open-circuit mode and the electrons in closed- ...

SENSOR CHIP, SENSING APPARATUS, COVER, BODY FLUID COLLECTION DEVICE, AND SENSOR

A sensor chip (), to be brought close to an organism to collect a body fluid in order to chemically measure the body fluid, is configured such that a surface () to be brought close to the organism is curved. 1. (canceled)2. (canceled)3. (canceled)4. (canceled)5. (canceled)6. A sensor chip to be brought in close proximity to a living body for collecting a body fluid and measuring a chemical substance in the body fluid , the sensor chip comprising:a body fluid collection unit having a surface configured by a curved surface and configured to be brought in close proximity to the living body and having a body fluid collection port for collecting the body fluid; anda sensing unit for performing a chemical measurement on the bodily fluid collected by the body fluid collection unit; anda fluid channel unit defining a fluid channel fluidly connecting the body fluid collection unit and the sensing unit.7. The sensor chip of claim 6 ,wherein the body fluid collection unit and the sensing unit are detachable from each other.8. The sensor chip of claim 6 ,wherein the body fluid collection unit further comprises a fluid channel fluidly connecting the bodily fluid collection port to the sensing unit.9. (canceled)10. The sensor chip of claim 8 ,wherein at least a portion of a surface of the fluid channel is hydrophilic.11. The sensor chip of claim 8 ,wherein the body fluid, upon contact with the body fluid collection port, flows into the fluid channel by surface tension.12. The sensor chip of claim 8 , further comprising a liquid absorber disposed to the fluid channel fluidly connecting the body fluid collection port to the sensing unit.13. The sensor chip of claim 6 , further comprising:an electrochemical electrode configured to contact the bodily fluid;an output terminal for outputting an electric signal generated by the electrochemical electrode; anda wiring for connecting the electrochemical electrode and the output terminal.14. The sensor chip of claim 13 , wherein the ...

Analyte Measurement Devices and Systems, and Components and Methods Related Thereto

In some aspects, a modular analyte measurement system having a replaceable strip port module is provided to permit contaminated modules to be replaced. Some aspects of the present disclosure related to barriers for strip ports or the sealing of strip ports and/or analyte measurement devices to maintain a clean strip port and/or enable the strip port to be cleaned for reuse. Cleaning tools are also provided. Also provided are strip port interfaces that guide fluid away from the strip port opening, as well as absorptive elements that prevent fluid from entering a strip port. Analyte measurement devices with gravity sensors or accelerometers are also provided, along with methods related thereto. Also provided are docking station that serve as an information server and provides storage and recharging capabilities. 118-. (canceled)19. A method for determining the concentration of analyte in a sample using an analyte measurement system , the method comprising: a module housing comprising an electrical interface aperture that exposes an electrical interface within the module housing, and', 'an analyte test strip port disposed within the module housing and comprising electrical contacts that couple to an analyte test strip positioned in the analyte test strip port,', 'wherein the electrical interface is disposed within the module housing and coupled to the analyte test strip port, and wherein the electrical interface comprises a plurality of electrical contacts that couple to electrical contacts of the analyte meter through the electrical interface aperture of the module housing;, 'positioning a replaceable strip port module within a strip port cavity of a housing of an analyte meter, wherein the analyte meter comprises the housing and electrical connections disposed with the strip port cavity within the housing, and the replaceable strip port module comprisescontacting the sample to the analyte test strip positioned in the analyte test strip port of the replaceable strip ...

LIQUID SAMPLE MEASURING SYSTEM AND MEASURING DEVICE

A liquid sample measuring system includes a measuring device including a measuring section which measures biological information from liquid sample of a living subject within a housing in which a biosensor, on which the liquid sample of the biological body is deposited, is detachably mounted and a movement measuring section which measures movement information of the housing within the housing, and an administrating device including a movement determining section which determines whether or not a degree of the movement of the housing is within an allowable range by analyzing the movement information received from the measuring device. 1. A liquid sample measuring device , comprising:a housing to which a biosensor on which a liquid sample of a living subject is deposited is detachably mounted;a measuring section configured to measure biological information from the liquid sample of the living subject, the measuring section disposed inside of the housing;a movement measuring section configured to measure movement information of the housing, the movement measuring section disposed inside the housing;a movement determining section configured to analyze the movement information and determine whether a degree of movement is within an allowable range; anda display section configured to display an instruction program that instructs a user how to handle the housing,wherein the display section displays the instruction program according to a result of determining by the movement determining section before the measuring section measures the biological information and/or after the measuring section measures the biological information.2. The liquid sample measuring device according to claim 1 , wherein:the movement determining section is further configured to determine whether the degree of the movement of the housing during a time from when the biosensor is mounted to the housing to when measuring the biological information by the measuring section ends.3. The liquid sample ...

BIOSENSOR SYSTEM, SENSOR CHIP, AND METHOD OF MEASURING ANALYTE CONCENTRATION IN BLOOD SAMPLE

The present invention provides a biosensor system that can prevent a measurement error caused by the temperature of the environment in use from occurring. A biosensor system includes a measuring instrument having an operation part , and a sensor chip that is insertable into and removable from the measuring instrument and into which a blood sample is introduced. The sensor chip includes a measurement part (a measurement part A) that acquires Data a related to the concentration of an analyte in a blood sample based on the amount of electric current that flows in the blood sample due to a reaction in which an oxidoreductase with the analyte used as a substrate is involved, and a measurement part (a measurement part B) that acquires, from the blood sample, Data b for temperature correction of Data a. The operation part has a function of determining the concentration of the analyte in the blood sample, with the concentration having been corrected according to the temperature of the blood sample based on Data a and Data b. 119-. (canceled)20. A biosensor system , comprising:a measuring instrument having an operation part; and a capillary part that holds a blood sample introduced into the sensor chip;', 'a measurement part A including an electrode A and an electrode B in the capillary part;', 'a measurement part B including the electrode A and an electrode C in the capillary part;', 'a reaction reagent layer formed on the electrodes A and B but not on the electrode C; and', 'a spacer formed on the reaction reagent layer, wherein, 'a sensor chip that is insertable into and removable from the measuring instrument, and comprisesthe operation part has a conversion table established using a relationship where the amount of electric current that flows in a blood sample due to the reaction involving the oxidoreductase with the analyte used as a substrate varies in the same manner as the amount of electric current that flows in a blood sample according to oxidation or reduction of ...

PROGRAMMABLE EPIDERMAL MICROFLUIDIC VALVING SYSTEM FOR WEARABLE BIOFLUID MANAGEMENT AND CONTEXTUAL BIOMARKER ANALYSIS

Active biofluid management may be advantageous to the realization of wearable bioanalytical platforms that can autonomously provide frequent, real-time, and accurate measures of biomarkers in epidermally-retrievable biofluids (e.g., sweat). Accordingly, exemplary implementations include a programmable epidermal microfluidic valving system capable of biofluid sampling, routing, and compartmentalization for biomarker analysis. An exemplary system includes a network of individually-addressable microheater-controlled thermo-responsive hydrogel valves, augmented with a pressure regulation mechanism to accommodate pressure built-up, when interfacing sweat glands. The active biofluid control achieved by this system may be harnessed to create unprecedented wearable bioanalytical capabilities at both the sensor level (decoupling the confounding influence of flow rate variability on sensor response) and the system level (facilitating context-based sensor selection/protection). Through integration with a wireless flexible printed circuit board and seamless bilateral communication with consumer electronics (e.g., smartwatch), contextually-relevant (scheduled/on-demand) on-body biomarker data acquisition/display may be achieved.

SYSTEMS AND METHODS INCLUDING ELECTROLYTE SENSOR FUSION

Embodiments herein relate to systems and methods for combining data from different types of sensors. In an embodiment, a medical system is included. The medical system can include a first sensor configured to produce a first value for an analyte and a second sensor different than the first sensor, the second sensor configured to produce a second value for the analyte. The medical system can also include a controller configured to receive the first and second values. The controller can create a blended analyte value from the first value and second value. Other embodiments are included herein. 1. A medical system comprisinga first sensor configured to produce a first value for an analyte;a second sensor different than the first sensor, the second sensor configured to produce a second value for the analyte; anda controller configured to receive the first and second values;wherein the controller creates a blended analyte value from the first value and second value.2. The medical system of claim 1 , wherein the controller creates a blended analyte value by using the first value to normalize the second value or by using the second value to normalize the first value.3. The medical system of claim 2 , wherein the blended analyte value is created using a method that reduces at least one of sensor offset errors claim 2 , sensor gain errors and sensor latency as compared with values from the first sensor and second sensor standing alone.4. The medical system of claim 1 , wherein at least one of the first sensor and the second sensor is implantable.5. The medical system of claim 1 , wherein at least one of the first sensor and the second sensor is an optical chemical sensor.6. The medical system of claim 5 , wherein the optical chemical sensor measures one or more of an electrolyte claim 5 , a protein claim 5 , a sugar claim 5 , a hormone claim 5 , a peptide claim 5 , an amino acid and a metabolic product.7. The medical system of claim 6 , wherein the electrolyte is at least ...

Biosensor, biosensor chip and biosensor device

A biosensor includes a working electrode 101, a counter electrode 102 opposing the working electrode 101, a working electrode terminal 103 and a working electrode reference terminal 10 connected to the working electrode 101 by wires, and a counter electrode terminal 104 connected to the counter electrode 102 by a wire. By employing a structure with at least three electrodes, it is possible to assay a target substance without being influenced by the line resistance on the working electrode side.

HIGH-SENSITIVITY BIOSENSOR AND METHOD FOR PRODUCING THE SAME

[Problem to be Solved] 1. A biosensor comprising:an identification substance capable of binding to a substance to be detected;an electrode charged with a charge of the identification substance, and able to detect a change in a charge density of the electrode caused by binding of the substance to be detected to the identification substance anda polymer layer in which a molecular template having a structure complementary to a molecular structure of the substance to be detected formed on all or part of a surface of the electrode, wherein the identification substance is contained in the polymer layer and the polymer layer is an ultrathin film layer.2. The biosensor according to claim 1 , wherein the ultrathin film layer is a thin film layer having a thickness of 1 μm or less.3. The biosensor according to claim 1 , wherein the polymer layer is formed by a method comprising:(a) polymerizing a monomer solution comprising one or more monomers, the substance to be detected, and the identification substance on all or part of the surface of the electrode to form a polymer layer being an ultrathin film layer on all or part of the surface of the electrode; and(b) removing the substance to be detected from the polymer layer to form the molecular template having a structure complementary to the molecular structure of the substance to be detected in the polymer layer, after (a).4. The biosensor according to claim 3 , wherein polymerization of the monomer solution is living radical polymerization or electrolytic polymerization.5. The method according to claim 4 , wherein the living radical polymerization is atom transfer radical polymerization (ATRP) claim 4 , reversible addition-fragmentation chain transfer polymerization (RAFT) claim 4 , or nitroxide-mediated polymerization (NMP).6. The biosensor according to claim 5 , wherein the living radical polymerization is atom transfer radical polymerization (ATRP) claim 5 , and wherein prior to (a) a polymerization-initiating molecule is ...

Electrochemical Biosensor

Provided is a biosensor having i) sufficient sensitivity allowing quantitative detection of a low concentration of an analyte; and ii) excellent selectivity allowing selective distinction of the presence of an analyte. 1. A biosensor comprising:a first sensor comprising a first operation electrode and a first counter electrode that is spaced apart from the first operation electrode;a second sensor comprising a second operation electrode and a second counter electrode that is spaced apart from the second operation electrode, wherein a surface of the second operation electrode is coated with a detecting reagent layer comprising an enzyme; anda controller receives a first detect signal from the first sensor and a second detect signal from the second sensor, wherein the controller outputs a quantitative analysis value corresponding to the first detect signal and a qualitative analysis value corresponding to the second detect signal.2. The biosensor of claim 1 , wherein the quantitative analysis value is an absolute value of a concentration of an analyte.3. The biosensor of claim 1 , wherein the qualitative analysis value is at least one of absent claim 1 , present claim 1 , decreased claim 1 , constant claim 1 , and increased.4. The biosensor of claim 3 , wherein the controller outputs information of undetectableness as the quantitative analysis value claim 3 , when at least one of a) the qualitative analysis value is present and decreased claim 3 , and the quantitative analysis value is constant or increased compared with a previous measurement run claim 3 , b) the qualitative analysis value is present and constant claim 3 , and the quantitative analysis value is decreased or increased compared with a previous measurement run claim 3 , and c) the qualitative analysis value is present and increased claim 3 , and the quantitative analysis value is decreased or constant compared with a previous measurement run.5. The biosensor of claim 1 , wherein the qualitative analysis ...

Cationic Polymer Based Wired Enzyme Formulations for Use in Analyte Sensors

Embodiments of the invention include analyte-responsive compositions and electrochemical analyte sensors having a sensing layer that includes an analyte-responsive enzyme and a cationic polymer. Also provided are systems and methods of making the sensors and using the electrochemical analyte sensors in analyte monitoring. 160-. (canceled)61. A method for monitoring a level of an analyte , the method comprising: a substrate comprising a working electrode and a counter electrode or a counter/reference electrode;', 'a sensing layer disposed on the working electrode, wherein the sensing layer comprises an analyte-responsive enzyme, a cationic polymer selected from the group consisting of polyallylamine (PAH), polyethyleneimine (PEI), poly(L-lysine) (PLL), or poly(L-arginine) (PLA), and a positively charged redox mediator non-covalently associated with the cationic polymer;, 'inserting an electrochemical sensor into the skin of a subject, the electrochemical sensor comprisingattaching an electrochemical sensor control unit to the electrochemical sensor and the skin of the subject;collecting data, using the sensor control unit, regarding a level of an analyte from signals generated by the sensor;transmitting the collected data to a display unit using an rf transmitter of the sensor control unit; anddisplaying an indication of the level of the analyte on the display of the display unit.62. The method of claim 61 , wherein the analyte is glucose.63. The method of claim 61 , wherein the analyte-responsive enzyme is a glucose-responsive enzyme.64. The method of claim 63 , wherein the glucose-responsive enzyme is glucose oxidase (GOx).65. The method of claim 63 , wherein the glucose-responsive enzyme is glucose dehydrogenase (GDH).66. The method of claim 61 , wherein the analyte is lactose.67. The method of claim 61 , wherein collecting data comprises generating signals from the sensor and processing the signals into data.68. The method of claim 61 , wherein the data comprises ...

SWEAT SIMULATION, COLLECTING AND SENSING SYSTEMS

Biological chemicals, potentially found in blood are measured by collecting sweat and determining the concentration or meaning of the selected chemical in sweat. The sweat can be collected using a time based, interval collector and analyzed using an external device. It can also be collected on a one time basis, using a flexible, chemical capacitor, or on a continuous basis using a chemical, field effect transducer. 1. A fluid sample collector comprising an aqueous fluid absorbing member;a plurality of discrete fluid transporting paths, each path leading from said absorbing member to a separate collection member;each path having a separate time dependent flow restrictor, wherein each flow restrictor allows fluid flow into one of said collection members at a different time;a flow bridge in each of said paths effective to stop fluid flow from one of said absorbing member to a corresponding collection member.2. Sample collector claimed in wherein said absorbing member in a fibrous pad.3. The sample collector claimed in wherein said flow restrictors are each water soluble polymer films.4. The sample collector claimed in wherein said bridge is a water soluble polymer fibrous thread.5. The sample collector claimed in wherein each of said water soluble polymer films has a different solubility.6. The sample collector claimed in wherein said polymer film is polyethylene oxide.7. The sample collector claimed in wherein said flow restrictors are physical obstacles.8. The sample collector claimed in wherein said physical obstacles comprise a flow paths having different widths.9. The sample collector claimed in wherein each of said paths extends radially outwardly from said collection member.10. A method of collecting an aqueous sample over time comprising collecting a sample at a central collection member and allowing said sample to flow to a plurality of separate collection members claim 1 , collecting sample portions in each of said collection members at different times.11. ...

SENSOR ASSEMBLY, TEST SUBSTANCE MONITORING SYSTEM, AND TEST SUBSTANCE MONITORING METHOD

Disclosed are a novel means capable of accurately calculating the amount of in-vivo components as a test substance, and its uses. A sensor assembly includes an electrochemical sensor for measuring a test substance percutaneously extracted from a living body, and a processor for calculating the intensity of the background signal at the measurement time point of the test substance after the elapse of the predetermined time based on the change over time of the intensity of the background signal measured within a predetermined time before measurement of the test substance by the electrochemical sensor . In this way, the amount of the in-vivo component as the test substance can be accurately calculated since the calculated value of the intensity of the background signal to be subtracted from the unprocessed signal including the signal attributable to the test substance can be obtained. 1. A sensor assembly comprising:an electrochemical sensor for measuring a test substance percutaneously extracted from a living body; anda processor programmed to determine the intensity of the background signal at a measurement time point of the test substance outside the predetermined time based on the intensity of the background signal measured within the predetermined time by the electrochemical sensor.2. The sensor assembly according to claim 1 , whereinthe predetermined time is the time period from when the electrochemical sensor is energized to when the measured value by the electrochemical sensor stabilizes.3. The sensor assembly according to claim 1 , whereinthe electrochemical sensor is configured to measure a test substance extracted into a collection member from the living body in a state in which the test substance is in contact with the collecting member;the predetermined time is the time before the test substance is extracted to the collection member after the electrochemical sensor is brought into contact with the collecting member; andthe electrochemical sensor measures ...

BLOOD GLUCOSE MONITORING DEVICE

A blood glucose monitoring device includes a container, blood glucose test strips and a glucometer. The container includes a body and a cap. The cap or the body has thereon a rewritable signal component preconfigured with a test strip information. The test strip information includes traceability of the blood glucose test strips. The rewritable signal component sends by wireless communication technology an electronic signal carrying the test strip information. The glucometer includes a casing, processing module built-in with a comparison data, control panel, test slot, and signal processing component. The signal processing component receives the electronic signal of the container by the wireless communication technology. The processing module determines whether the test strip information matches the comparison data and creates a container-opened message when the determination is affirmative, thereby allowing the blood glucose test strips to be for use by the glucometer. 1. A blood glucose monitoring device , comprising:a container comprising a body and a cap, the body receiving therein blood glucose test strips, the cap or the body having thereon a rewritable signal component preconfigured with a test strip information, the test strip information including traceability of the blood glucose test strips, the rewritable signal component sending by wireless communication technology an electronic signal carrying the test strip information; anda glucometer comprising a casing, a processing module disposed in the casing, a control panel, at least a test slot for holding each one of the blood glucose test strips, and a signal processing component electrically connected to the processing module, the processing module being built-in with a comparison data, the signal processing component receiving the electronic signal of the container by the wireless communication technology, wherein the processing module determines whether the test strip information matches the comparison ...

Biosensor, biosensor chip and biosensor device

A biosensor includes a working electrode 101 , a counter electrode 102 opposing the working electrode 101 , a working electrode terminal 103 and a working electrode reference terminal 10 connected to the working electrode 101 by wires, and a counter electrode terminal 104 connected to the counter electrode 102 by a wire. By employing a structure with at least three electrodes, it is possible to assay a target substance without being influenced by the line resistance on the working electrode side.

Devices, systems, and methods for performing optical assays

This present invention relates generally to devices, systems, and methods for performing optical and electrochemical assays and, more particularly, to devices and systems having universal channel circuitry configured to perform optical and electrochemical assays, and methods of performing the optical and electrochemical assays using the universal channel circuitry. The universal channel circuitry is circuitry that has electronic switching capabilities such that any contact pin, and thus any sensor contact pad in a testing device, can be connected to one or more channels capable of taking on one or more measurement modes or configurations (e.g., an amperometric measurement mode or a current drive mode).

DEVICES, SYSTEMS, AND METHODS FOR PERFORMING OPTICAL AND ELECTROCHEMICAL ASSAYS

This present invention relates generally to devices, systems, and methods for performing optical and electrochemical assays and, more particularly, to devices and systems having universal channel circuitry configured to perform optical and electrochemical assays, and methods of performing the optical and electrochemical assays using the universal channel circuitry. The universal channel circuitry is circuitry that has electronic switching capabilities such that any contact pin, and thus any sensor contact pad in a testing device, can be connected to one or more channels capable of taking on one or more measurement modes or configurations (e.g., an amperometric measurement mode or a current drive mode). 1. A system for performing multiple assays on a biological sample , comprising:an analyzer comprising: a cartridge port for mating with a test cartridge, a multi-terminal connector, a processor, memory coupled to the processor, and universal channel circuitry, wherein the universal channel circuitry comprises a first channel, a second channel, and a third channel;a first test cartridge comprising a light emitter connected to a first contact and a light detector connected to a second contact; anda second test cartridge comprising an amperometric electrode connected to a third contact and a reference electrode connected to a fourth contact,wherein the first contact is electrically connectable to a first pin of the multi-terminal connector, and the second contact is electrically connectable to a second pin of the multi-terminal connector;wherein the third contact is electrically connectable to the first pin of the multi-terminal connector, and the fourth contact is electrically connectable to the second pin of the multi-terminal connector;wherein the first pin is electrically connectable to the first channel, and the second pin is electrically connectable to the second channel;wherein when the first test cartridge is inserted into the port of the analyzer, the first ...

Method of operation of a meter

The method of operation of a meter includes placing a sample on a test strip, assigning a first electrode of the test strip to be a counter electrode, applying a first signal to the test strip during a first period of time, assigning a second electrode of the test strip to be the counter electrode, applying a second signal to the test strip to measure the concentration of an analyte in the sample. 1. A method of operation of a meter to measure a response of a sample on a reaction chamber of a test strip , comprising:assigning a first electrode of the test strip to be a counter electrode;applying a first signal to a working electrode of the test strip during a first period of time;assigning a second electrode of the test strip to be the counter electrode;applying a second signal to the working electrode of the test strip during a second period of time; andmeasuring the response during the second period of time.2. The method of claim 1 , wherein assigning the first electrode of the test strip to be the counter electrode and assigning the second electrode of the test strip to be the counter electrode is performed using at least one switch of the meter.3. The method of claim 1 , further comprising assigning the first electrode of the test strip to be a reference electrode before applying the second signal to the working electrode of the test strip during the second period of time.4. The method of claim 1 , further comprising assigning the second electrode of the test strip to be a reference electrode before applying the first signal to the working electrode of the test strip during the first period of time.5. The method of claim 1 , wherein said the response is measuring a current across the working electrode and the second electrode.6. The method of claim 1 , wherein the test strip comprises at least four electrodes.7. The method of claim 6 , wherein assigning a third electrode of the test strip to be the reference electrode during the first period and second period of ...

Measuring Method and Measuring Apparatus

A measuring method includes applying a first signal, which is a direct current signal, having a first value to a sample in a flow passage using a first electrode and a fourth electrode which is different from the first, second, and third electrodes, measuring a first electric response value, applying a second signal having a second value higher than the first value to the sample using the second and third electrodes, measuring a second electric response value, and correcting a value obtained from the first electric response value based on the second electric response value. 1. A measuring method for measuring a target substance contained in a sample by using an analysis tool including a flow passage for the sample and a plurality of electrodes arranged in the flow passage , the measuring method comprising:the plurality of electrodes including a first electrode which is provided with a reagent including an enzyme, a second electrode and a third electrode each of which is not provided with the reagent, and a fourth electrode which is different from the first electrode, the second electrode, and the third electrode,applying a first signal, which is a direct current signal, having a first value to the sample in the flow passage by using the first electrode as a working electrode and using the fourth electrode as a counter electrode;measuring a first electric response value of the sample to the first signal;applying contiguously for a given time a second signal, which is a direct current signal, having a second value higher than the first value to the sample in the flow passage by using the second electrode and the third electrode as the working electrode and the counter electrode;measuring a second electric response value of the sample within the given time to the second signal, the second electric response value indicating amount of electric charge generated by electrolysis of water in the sample; andcorrecting a value obtained from the first electric response value ...

METHOD AND APPARATUS FOR ENCODING TEST STRIPS

A test meter for receiving a test strip comprises: 1. An electrochemical test strip , said test strip being generally planar and comprising a sample cell for receiving a test sample for analysis and electrodes disposed within the sample cells for performing an electrochemical assay , said test strip having a top surface and a bottom surface , wherein the test strip compromises a connection region and wherein the test strip further comprises:(a) electrical connectors for connecting the electrodes to a test meter, said electrical connectors being disposed within the connection region and exposed for connection on the top surface, and(b) a plurality of encoding pads disposed within the connection region on the bottom surface of the test strip, wherein at least two of the encoding pads are in electrical connection with each other.2. The test strip of claim 1 , wherein there are five encoding pads on the bottom surface of the test strip.3. The test strip of claim 1 , wherein all of the encoding pads are in electrical contact with one another.4. The test strip of claim 1 , wherein a notch is cut from the test strip to electrically isolate one of the encoding pads from the other encoding pads.5. The test strip of claim 1 , wherein additional coding information is provided on the top surface of the test strip.6. The test strip of claim 5 , wherein at least one encoding pad is provided on the top surface in electrical isolation from other encoding pads on the top surface.7. A combination of a housing;', 'electronic circuitry disposed within the housing; and', wherein the strip port connector contains a pair of opposed contacts, each contact having a proximal end, a distal end, and a central contact portion, and', 'wherein the electronic circuitry is configured to test for electrical contact between the pair of top and bottom contacts one or more times when no test strip is received in the meter; and, 'a strip port connector connected to the electronic circuitry and extending ...

ANALYTE SENSORS AND SYSTEMS INCLUDING RETENTION TAB AND METHODS OF MANUFACTURING SAME

In some aspects, an analyte sensor is provided for detecting an analyte concentration level in a biological fluid sample. The analyte sensor has a base including a top and bottom side, a lid, and an attachment member including one or more retention tabs coupled proximate the top side so that the analyte sensor can be grasped by the sensor's top side. Manufacturing methods and systems adapted to use and dispense the analyte sensors are provided, as are numerous other aspects. 1. An analyte testing system , comprising:an analyte meter including a pylon having grasping tabs; andan analyte sensor including a base with a top side, a lid proximate the base on the top side, and an attachment member proximate the top side, the attachment member including one or more retention tabs engaging with the grasping tabs to secure the analyte sensor to the pylon.2. The analyte testing system of claim 1 , further comprising electrical connectors on the pylon adapted to contact electrical contact pads provided on a same side of the base as the attachment member.3. The analyte testing system of claim 1 , wherein the grasping tabs are movable to release the attachment member.4. The analyte testing system of claim 3 , comprising a user-operable mechanism adapted to initiate movement of the grasping tabs.5. An analyte sensor dispenser apparatus claim 3 , comprising:a dispenser body having a recess extending in the dispenser body and an opening; anda plurality of analyte sensors provided in a stacked configuration within the recess, the plurality of analyte sensors including an attachment member having one or more retention tabs disposed towards the opening and adapted to be grasped by an analyte meter.6. The analyte sensor dispenser system of claim 5 , wherein the attachment member includes two retention tabs. This application is a division of U.S. patent application Ser. No. 13/589,377, filed Aug. 20, 2012, titled “ANALYTE SENSORS AND SYSTEMS INCLUDING RETENTION TAB AND METHODS OF ...

GATED VOLTAMMETRY METHODS

A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Gated voltammetric pulse sequences including multiple duty cycles of sequential excitations and relaxations may provide a shorter analysis time and/or improve the accuracy and/or precision of the analysis. The disclosed pulse sequences may reduce analysis errors arising from the hematocrit effect, variance in cap-gap volumes, non-steady-state conditions, mediator background, a single set of calibration constants, under-fill, and changes in the active ionizing agent content of the sensor strip. 148-. (canceled)49. A method of determining a concentration of an analyte in a fluid sample comprising:applying a first input signal, the first input signal including a first pulse sequence having at least one duty cycle, the at least one duty cycle of the first pulse sequence including an excitation and a relaxation;measuring a preliminary output signal responsive to the first input signal;determining a preliminary concentration of the analyte based on the preliminary output signal and one or more previously determined calibration constants;responsive to the preliminary concentration of the analyte being less than a predetermined threshold concentration range, applying a second input signal, the second input signal including a second pulse sequence having at least one duty cycle, the at least one duty cycle of the second pulse sequence including an excitation and a relaxation;measuring a final output signal responsive to the second input signal; anddetermining a final concentration of the analyte based on the final output signal and the one or more previously determined calibration constants.50. The method of claim 49 , wherein the first pulse sequence and the second pulse sequence are gated voltammetric pulse sequences.51. The method of claim 49 , wherein each duty cycle has an excitation/relaxation time ratio from 0.3 to 0.2.52. The method of claim 51 , wherein ...

HAND-HELD TEST METER WITH SMOOTH DIMPLED ELECTRICAL CONTACTS, CONTACT STOPPER RIBS, AND METAL SHIELD PLATE

A hand-held test meter for use with an analytical test strip for the determination of an analyte in a bodily fluid sample includes a test meter housing with a housing outer surface and a distal end, a PCB disposed within the test meter housing; a SPC disposed in the test meter housing, and a metal shield plate securely attaching the strip port connector to the PCB. The SPC includes a SPC housing with at least one contact stopper rib, and plurality of electrical contacts (e.g., electrical contacts with a T-bar shaped distal end) disposed in the SPC housing. Each of the plurality of electrical contacts has a distal end and a test strip contact surface (TSCS). The TSCS of the electrical contact is configured for operable contact with an analytical test strip received in the SPC and the TSCS of the electrical contact is a smooth dimpled surface. 2. The hand-held test meter of wherein the strip port connector (SPC) is attached to the printed circuit board (PCB) via solder connection between the PCB and the metal shield plate.3. The hand-held test meter of wherein the distal end of each of the plurality of electrical contacts is T-shaped.4. The hand-held test meter of wherein the smooth dimpled surface includes a dimple with smooth edges on either side of a longitudinal center line of the electrical contact.5. The hand-held test meter of wherein there are three electrical contacts.6. The hand-held test meter of wherein the SPC housing is formed of a polymeric material.7. The hand-held test meter of wherein the metal shield plate is secured to the SPC housing via snap fit between the SPC housing and the metal shield plate.8. The hand-held test meter of wherein SPC housing includes at least one laser alignment opening.9. The hand-held test meter of wherein the electrical contact has a predetermined elastic force due at least in part to a bend in the electrical contacts.10. The hand-held test meter of wherein the hand-held test meter and analytical test strip are configured ...

METHOD AND APPARATUS FOR ANALYZING CONCENTRATION STATE OF MEASUREMENT TARGET COMPONENT IN BLOOD

Disclosed is a method for analyzing a concentration state of a measurement target component in blood, the method including: obtaining a value regarding an amount of the measurement target component in a collection member in which tissue fluid has been accumulated in advance, the tissue fluid having been extracted for a predetermined extraction time period from an organism which had been subjected to a process for accelerating the extraction of the tissue fluid; obtaining a value of an area under a blood concentration time curve of the measurement target component on the basis of the value regarding the amount of the measurement target component; and calculating a value regarding a ratio of a time period during which a concentration of the measurement target component has exceeded a predetermined concentration relative to the extraction time period, on the basis of the value of the area under the blood concentration time curve. 1. A method for analyzing a concentration state of a measurement target component in blood , the method comprising:obtaining a value regarding an amount of the measurement target component in a collection member in which tissue fluid has been accumulated in advance, the tissue fluid having been extracted for a predetermined extraction time period from an organism which had been subjected to a process for accelerating the extraction of the tissue fluid;obtaining a value of an area under a blood concentration time curve of the measurement target component on the basis of the value regarding the amount of the measurement target component; andcalculating a value regarding a ratio of a time period during which a concentration of the measurement target component has exceeded a predetermined concentration relative to the extraction time period, on the basis of the value of the area under the blood concentration time curve.2. The method for analyzing the concentration state of the measurement target component in blood of claim 1 , further comprising: ...

Integrated lancing device with testing meter

The medical testing instrument integrates the multiclix insulin pen with lancet and with testing meter which show the result on the touch screen. The device also, can connect to smart phone application through Bluetooth or other wireless connections.

Cationic Polymer Based Wired Enzyme Formulations for Use in Analyte Sensors

Embodiments of the invention include analyte-responsive compositions and electrochemical analyte sensors having a sensing layer that includes an analyte-responsive enzyme and a cationic polymer. Also provided are systems and methods of making the sensors and using the electrochemical analyte sensors in analyte monitoring.

BIOSENSOR MONITORS, TEST STRIPS AND ACTIVATION MECHANISMS AND METHODS THEREOF

The disclosure is directed to biosensor monitors, test strips and activation mechanisms and methods thereof. The biosensor monitor is for verifying a test strip to be used with the biosensor monitor. The monitor includes verification components located within the monitor and accessible to a test strip to be inserted into the biosensor monitor. The verification components interact with verification portions of the test strip to allow the biosensor monitor to verify the test strip before the biosensor monitor tests biological material on the test strip. A test strip and methods are also described. 1. A method for verifying a test strip comprising:sensing a presence of a test strip in a biosensor monitor;receiving a signal at one or more verification components of the biosensor monitor from one or more verification portions of the test strip;verifying the identity of the test strip.2. The method of claim 1 , wherein the verification portions of the test strip comprise conductive pads and the method further comprising applying a plurality of different electrical potentials to the conductive pads of the test strip.3. The method of claim 2 , wherein applying the plurality of different electrical potentials comprises applying different combinations of the plurality of different electrical potentials to the one or more verification portions of the test strip.4. The method of claim 2 , wherein the one or more verification portions comprise a plurality of verification portions and applying the plurality of different electric potentials comprises applying different combinations of the plurality of different electrical potentials to the plurality of verification portions of the test strip.5. The method of claim 1 , wherein light is emitted from the one or more verification component of the biosensor and light reflected off of the one or more verification portions of the test strip is detected claim 1 , wherein at least a portion of the one or more verification portions comprise ...

WASHABLE ANALYTE METERS, SEALED CONNECTORS, AND METHODS OF MANUFACTURING AND USING SAME

An analyte meter to detect an analyte concentration level in a bio-fluid sample may be cleaned and disinfected with a cleaning liquid without harming electrical and internal meter components. In some embodiments, the analyte meter is washable and immersable and may include a sealed sensor connector, sealed battery connector, and possibly a sealed USB connector that may be subjected to a cleaning liquid without the liquid entering an internal chamber of the analyte meter and contacting internal electronic components. In some embodiments, a sealed display screen and sealed keypad are provided such that liquids are prevented from entering the internal chamber. Manufacturing methods and systems utilizing the analyte sensors are provided, as are numerous other aspects. 2. The analyte meter of claim 1 , further comprising a display screen sealed to the meter housing to prevent fluids from entering the internal chamber.3. The analyte meter of claim 1 , further comprising a keypad sealed to the meter housing to prevent fluids from entering the internal chamber.4. The analyte meter of claim 1 , further comprising a battery connector sealed to the meter housing to prevent fluids from entering the internal chamber.5. The analyte meter of claim 1 , further comprising a universal serial bus (USB) port sealed to the meter housing to prevent fluids from entering the internal chamber.6. The analyte meter of claim 1 , wherein the electronic components comprise a processor and a memory.7. The analyte meter of claim 1 , further comprising at least two electrical connectors coupled respectively to the at least two electrodes via the sealed connection such that an end of each of the at least two electrical connectors extends beyond a connector body of the analyte sensor electrical connector unit.8. The analyte meter of claim 1 , wherein the meter housing comprises a first part and a second part interfacing with and sealed to one another to form the internal chamber.9. The analyte meter ...

METHOD AND SYSTEM TO DERIVE GLYCEMIC PATTERNS FROM CLUSTERING OF GLUCOSE DATA

Described are methods and systems for determining clusters of glucose data that can be utilized to provide insights to the person with diabetes, such as, for example, when a certain number of measurements during a predetermined time period is less than a predetermined threshold so that the subject is notified that the number of glucose measurements is less than optimum for management of diabetes. 15.-. (canceled)6. A system for management of diabetes of a subject , the system comprising:at least one glucose monitor that is configured to measure a glucose concentration based on an enzymatic reaction with physiological fluid in a biosensor that provides an electrical signal representative of the glucose concentration; anda controller in communication with at least one glucose monitor, the controller being configured to receive or transmit glucose data representative of glucose levels measured by the glucose monitor over a predetermined time period to determine plural clusters of glucose data with respect to glucose levels so that the glucose levels with reference to a predetermined time period are correlated to each other in a cluster due to their similarity as compared to glucose levels in other clusters and at least three clusters of glucose levels are provided to indicate the distribution of the glucose levels;wherein the controller annunciates an indication of the distribution of the at least three clusters into respective first range, second range, and third range of glucose values.7. The system of claim 6 , in which the first range of glucose values comprises a minimum greater than a maximum of the second range claim 6 , which has a minimum greater than a maximum of the first range.8. The system of claim 7 , in which the minimum of the first range comprises about 180 mg/dL of glucose claim 7 , the minimum of the second range comprises about 70 mg/dL.9. The system of claim 7 , in which each of the clusters comprises glucose measurements with respect specific time ...

Measurement device

A measurement device includes a housing to which a biosensor having a reagent is attachable and which is carriable by a user, the reagent selectively responding to a specific analyte in a biological fluid. An analyte measurer measures a concentration of the specific analyte, using the biosensor, a motion measurer measures vibration applied to the housing, as a motion amount, and a living activity calculator calculates a living activity amount based on the measured motion amount. A recorder records the living activity amount output by the living activity calculator and a controller causes the recorder to record the specific analyte concentration measured by the analyte measurer and an event of the living activity, the concentration and the event being associated with each other, the event of the living activity being estimated based on the living activity amount recorded in the recorder.

Measuring device and methods for use therewith

The ability to switch at will between amperometric measurements and potentiometric measurements provides great flexibility in performing analyses of unknowns. Apparatus and methods can provide such switching to collect data from an electrochemical cell. The cell may contain a reagent disposed to measure glucose in human blood. 1154-. (canceled)155. A test equipment for receiving an electrochemical cell comprising at least first and second electrodes and a reagent reactive with a constituent of a human bodily fluid , said equipment comprising:at least first and second connectors for providing electric contact between the test equipment and at least first and second electrodes of a received electrochemical cell, a source of potential for applying a potential difference between the at least first and second electrodes through the at least first and second connectors;potentiometric circuitry;electronic control means; the electronic control means coupled with the source of potential to controllably apply the source of potential to the electrochemical cell, thereby allowing current to flow through the cell; andamperometric means external to the electrochemical cell for measuring the flow of current through the electrochemical cell;wherein the electronic control means is coupled with the potentiometric circuitry to automatically cease application of potential to the electrochemical cell, and then cause the potentiometric circuitry to measure a decay in chemical potential at the electrochemical cell in the absence of the applied potential.156. The test equipment of further comprising a housing claim 155 , having an opening for receiving the electrochemical cell and placing it in electrical connection with the at least first and second connectors claim 155 , and wherein the housing contains the source of potential claim 155 , the potentiometric circuitry claim 155 , and the electronic control means.157. The test equipment of claim 156 , wherein the electronic control means ...

APPARATUS FOR DIAGNOSTIC METER STRIP CONTROL AND IDENTIFICATION

A system for measuring a property of a sample in a liquid which includes a test strip and a meter is provided. Some embodiments relate to a diagnostic test strip for collecting a sample, the strip having a plurality of electrodes for measuring a property of the sample, and the strip having a control circuit at a distal region of the strip, the control circuit configured to communicate with a controller of a meter, the control circuit including an embedded temperature sensor, a memory for lot coding and authentication of the test strip, and an inhibit logic for inhibiting the test from being used more than once; and a diagnostic meter for receiving the test strip, the meter having a controller programmed to communicate with the control circuit. 1. A system for measuring a property of a sample in a liquid , comprising:a diagnostic test strip for collecting a sample, the strip having a plurality of electrodes for measuring a property of the sample, and the strip having a control circuit at a distal region of the strip, configured to communicate with a controller of a meter, the control circuit including an embedded temperature sensor, a memory for lot coding and authentication of the test strip, and an inhibit logic for inhibiting the test from being used more than once; anda diagnostic meter for receiving the test strip, the meter having a controller programmed to communicate with the control circuit.2. The system according to claim 1 , wherein the control circuit comprises a non-volatile string of bits used to identify the strip as authentic.3. The system according to claim 1 , wherein the control circuit comprises a non-volatile string of bits used as lot codes.4. The system according to claim 1 , wherein the controller of the meter is further programmed to perform a test utilizing the test strip and to inhibit the test strip after the test has been completed.5. The system according to claim 1 , wherein the control circuit is configured to measure a temperature of ...

Mobile Voltammetric Analysis

A low-cost voltammetric analysis system using a mobile computing device having a microprocessor, a memory and an audio interface. The audio interface comprises an audio signal output having first and second channels and an audio signal input. The interface is connectible to a voltammetric cell comprising first and second electrodes, and the memory of the device contains instructions which, when executed by the microprocessor, cause the device to: generate an output voltage waveform between the first and second channels of the audio signal output, the output voltage waveform comprising a time-varying voltammetric driving potential and an AC perturbation; simultaneously with generating the output voltage waveform, capture an input voltage waveform received at the audio signal input; and record the input voltage waveform as a voltammetric response waveform within a data store.

Bio-sensor and manufacturing method therefor

Disclosed is a manufacturing method for a bio-sensor. The present manufacturing method comprise the steps of: preparing an acidic solution comprising an enzyme and a molecule containing a catechol group; an immersing electrodes in the acidic solution and applying a voltage to the electrodes, thereby attaching a structure, which is generated by a reaction of the enzyme and the molecule containing a catechol group, to the electrodes.

ANALYSIS DEVICE AND ANALYSIS METHOD

An analysis device includes an electrode which induces a surface current, a circuit which is electrically connected to the electrode, and guard wirings, each of which guards part of the circuit. A guard voltage to be input to the guard wirings is based on the non-inverting input voltage of differential amplifiers included in the circuit. The electrode preferably includes a working electrode provided with an enzyme layer which senses glucose and a counter electrode which receives an electric current generated in the working electrode. 1. An analysis device , comprising:an electrode which induces a surface current;a circuit which is electrically connected to the electrode; anda guard wiring which guards part of the circuit, whereina guard voltage to be input to the guard wiring is based on the non-inverting input voltage of a differential amplifier included in the circuit.2. The analysis device according to claim 1 , wherein the electrode includes a working electrode provided with an enzyme layer which senses glucose and a counter electrode which receives an electric current generated in the working electrode.3. The analysis device according to claim 2 , wherein the electrode further includes a reference electrode to be used for detecting the resistance of an electric current flowing through the working electrode.4. An analysis device claim 2 , comprising:an electrode which induces a surface current;a circuit which is electrically connected to the electrode; anda guard section which covers part of the circuit.5. The analysis device according to claim 4 , wherein the guard section covers part of a wiring constituting the circuit in the form of a cover cylinder.6. The analysis device according to claim 4 , wherein the electrode includes a working electrode provided with an enzyme layer which senses glucose and a counter electrode which receives an electric current generated in the working electrode.7. The analysis device according to claim 6 , wherein the electrode ...

ANALYTE MEASUREMENT METHOD AND SYSTEM

Described and illustrated herein are systems and exemplary methods of operating an analyte measurement system having a meter and a test strip. In one embodiment, the method may be achieved by applying a first test voltage between a reference electrode and a second working electrode and applying a second test voltage between the reference electrode and a first working electrode; measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample containing an analyte is applied to the test strip; measuring a fifth test current at the first working electrode; estimating a hematocrit-corrected analyte concentration from the first, second, third, fourth and fifth test currents; and annunciating the hematocrit-corrected analyte concentration. 1. An analyte measurement system to measure a glucose concentration in physiological fluid of a user , the system comprising:a test strip including a substrate having a reference electrode, a first working electrode and a second working electrode coated with a reagent layer having a mediator, the electrodes being connected to corresponding contact pads; andan analyte meter having a microprocessor and a test circuit in connection with a test strip port that receives the contact pads of the test strip so that the meter is configured to apply a test voltage after deposition of physiological fluid on the electrodes and determine a hematocrit-corrected glucose concentration from measured first, second, third, fourth and fifth test currents at first, second, third, fourth and fifth discrete intervals after application of the test voltage by the meter.2. An analyte measurement system to measure a glucose concentration in physiological fluid of a user , the system comprising: 'an analyte meter having a microprocessor and a test circuit in connection with a test strip port that receives the contact pads of the test strip so that the meter is configured to ...

Method of Determining An Analyte Concentration in a Sample

A reagent composition for a biosensor sensor strip is disclosed that provides for rapid rehydration after drying. The composition includes porous particles and is preferably formed as a colloidal suspension. The dried reagent composition including porous particles may provide analytically useful output from the sensor strip in a shorter time period than observed from dried reagent compositions using solid particles. The output signal from the porous particle compositions may be correlated to the analyte concentration of a sample within about two seconds. In this manner, an accurate concentration determination of an analyte concentration in a sample may be obtained in less time than from sensor strips including conventional compositions. The reagent composition including the porous particles also may allow for the redox reaction between the reagents and the analyte to reach a maximum kinetic performance in a shorter time period than observed from conventional sensor strips. 134-. (canceled)35. A biosensor system for determining the concentration of an analyte in a sample , the biosensor system comprising:a sensor strip including a reservoir for receiving the sample, a working electrode, a counter electrode, a reagent composition comprising an enzyme, an electron transfer mediator and porous particles with a plurality of pores having an average diameter from 0.05 micrometer to 10 micrometer and a void volume of at least 20% (v/v); anda measurement device comprising a sensor interface, signal generator, and a processor, the signal generator providing an electrical input signal to the sensor interface, the processor being adapted to (i) direct the signal generator to provide the electrical input signal to the sensor interface, (ii) receive an output signal from the sensor interface, and (iii) measure the at least one output signal to obtain a current value from an excitation wherein the initial current is greater than those that follow in the decay and within less than ...

Systems and methods for detection and quantification of analytes

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. In some embodiments, the reader component communicates with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

Analyte Determination Method and Analyte Meter

The presence of oxygen or red blood cells in a sample applied to an electrochemical test strip that makes use of a reduced mediator is corrected for by an additive correction factor that is determined as a function of the temperature of the sample and a measurement that reflects the oxygen carrying capacity of the sample. The measured oxygen carrying capacity can also be used to determine hematocrit and to distinguish between blood samples and control solutions applied to a test strip.

TEST SYSTEM FOR ANALYZING A SAMPLE OF A BODILY FLUID

A test system for analyzing a sample of a bodily fluid is provided and comprises: at least one test strip comprising at least one capillary channel comprising an inlet opening configured to receive the sample; a vent opening configured to provide an air vent to the capillary channel; and at least one zone consisting of a detection zone and a reagent zone; at least one measuring device configured for interacting with the test strip, the measuring device comprising at least one sealing element for hermetically sealing the vent opening from an ambient atmosphere; and at least one suction device adapted to provide an underpressure to the vent opening; wherein the measuring device further comprises at least one valve or is connectable to the valve, wherein the valve is configured to vent the vent opening of the test strip when the measuring device interacts with the test strip. 1. A test system for analyzing a sample of a bodily fluid comprising: an inlet opening configured to receive the sample of the bodily fluid;', 'a vent opening configured to provide an air vent to the capillary channel; and', 'at least one zone selected from the group consisting of a detection zone and a reagent zone;, 'at least one test strip comprising at least one capillary channel, the capillary channel comprising'} at least one sealing element configured for hermetically sealing the vent opening of the test strip from an ambient atmosphere; and', 'at least one suction device adapted to provide an underpressure to the vent opening;, 'at least one measuring device configured for interacting with the test strip, the measuring device comprising'}wherein the measuring device further comprises at least one valve or is connectable to the at least one valve.2. The test system according to claim 1 , wherein the valve comprises a three-way valve claim 1 , and wherein the vent opening is connected to a vent port or to the suction device.3. The test system according to claim 1 , wherein the valve is ...

ELECTROCHEMICAL TEST SENSOR

The present invention relates to electrochemical sensor strips and methods of determining the concentration of an analyte in a sample or improving the performance of a concentration determination. The electrochemical sensor strips may include at most 8 μg/mmof a mediator. The strips, the strip reagent layer, or the methods may provide for the determination of a concentration value having at least one of a stability bias of less than ±10% after storage at 50° C. for 4 weeks when compared to a comparison strip stored at −20° C. for 4 weeks, a hematocrit bias of less than ±10% for whole blood samples including from 20 to 60% hematocrit, and an intercept to slope ratio of at most 20 mg/dL. A method of increasing the performance of a quantitative analyte determination also is provided. 150-. (canceled)51. An electrochemical biosensor for determining an analyte concentration in a fluid sample , the biosensor comprising:a base;{'sup': 2', '2, 'a first electrode on the base including a first conductor and a reagent layer, the reagent layer including a mediator having a deposition density of at most 8 μg/mmand an enzyme system having a deposition density of at most 0.8 μg/mm;'}a second electrode on the base; anda lid, the lid and the base assisting in forming an opening to receive the fluid sample,wherein the biosensor provides a determined concentration value having a stability bias of less than +/−10% after storage at 50° C. for 2 weeks when compared to a comparison biosensor stored at −20° C. for 2 weeks.52. The biosensor of claim 51 , wherein the second electrode includes a second conductor and a second reagent layer.53. The biosensor of claim 52 , wherein the second reagent layer is different in composition from the reagent layer.54. The biosensor of claim 52 , wherein the second reagent layer is the same as the reagent layer.55. The biosensor of claim 51 , wherein the average initial thickness of the reagent layer is less than 8 μm.56. The biosensor of claim 55 , ...

BIOSENSOR AND DETECTION DEVICE

A TFT biosensor includes a gate electrode (silicon substrate), a reference electrode, and enzyme that is fixed to an insulating substrate spatially separated from the gate electrode and the reference electrode. A pH variation in the vicinity of an ion-sensitive insulating film is induced by a reaction between the enzyme and a sensing object material. The TFT biosensor can detect a concentration of the sensing object material with high sensitivity by detecting the pH variation as a threshold voltage shift of characteristics of a gate-source voltage to a source-drain current. 1. A biosensor , comprising:a semiconductor active layer;a gate insulating film that is provided on a first surface of the semiconductor active layer, and insulates the semiconductor active layer and a gate electrode from each other;an ion-sensitive insulating film that is provided on a second surface of the semiconductor active layer, and includes a region that comes into contact with a solution; andan enzyme that is fixed at a position spatially separated from the region, and reacts with a material in the solution to allow a potential variation in the region to occur,wherein an electrostatic capacity per unit area of the ion-sensitive insulating film is greater than an electrostatic capacity per unit area of the gate insulating film.2. The biosensor according to claim 1 , further comprising:a detection unit that detects a potential on the ion-sensitive insulating film after amplifying the potential with a value of a ratio obtained by dividing the electrostatic capacity per unit area of the ion-sensitive insulating film by the electrostatic capacity per unit area of the gate insulating film.3. The biosensor according to claim 1 , further comprising:a mechanism that controls a flow of a sensing object material between the ion-sensitive insulating film and the enzyme that is fixed to the position spatially separated from the ion-sensitive insulating film.4. The biosensor according to claim 1 , ...

DETECTION REAGENTS AND ELECTRODE ARRANGEMENTS FOR MULTI-ANALYTE DIAGNOSTIC TEST ELEMENTS, AS WELL AS METHODS OF USING THE SAME

Detection reagents, multi-analyte test elements, test systems, and multi-analyte measuring methods are provided. In particular, multi-analyte test elements have (1) a first working electrode and first counter electrode pair covered with a first analyte-specific reagent that includes an enzyme, a coenzyme and a first mediator and have (2) a second working electrode covered with a second analyte-specific reagent that includes an enzyme, a coenzyme and a second mediator, where the second mediator is different than the first mediator. The single counter electrode can be used as the counter electrode for both the first and second analyte measurements at their respective working electrodes. Moreover, the mediator concentrations, measurement ranges, and applied potential differences are not the same for each analyte-specific measurement. 1. A diagnostic test element comprising:a first working electrode;a second working electrode;a counter electrode; a first coenzyme-dependent enzyme or a substrate for the first coenzyme-dependent enzyme, a first coenzyme, and a first mediator to enable detection of a first analyte in a fluid sample applied to the first reagent based on a first electrical test sequence applied to the first working electrode and the counter electrode;', 'a second coenzyme-dependent enzyme or a substrate for the second coenzyme-dependent enzyme, a second coenzyme, and a second mediator, to enable detection of a second analyte in the fluid sample applied to a portion of the first reagent formed on the surface of the counter electrode and the second reagent based on a second electrical test sequence applied to the second working electrode and the counter electrode, wherein the second analyte is different than the first analyte and wherein at least one of the second coenzyme-dependent enzyme, the second coenzyme, or the second mediator of the second reagent differs with respect to type and/or concentration when compared to the first reagent.', 'a second reagent ...

Accurate analyte measurements for electrochemical test strip to determine analyte measurement time based on measured temperature, physical characteristic and estimated analyte value and their temperature compensated values

Various embodiments for a method that allow for a more accurate analyte concentration with a biosensor by determining at least one physical characteristic signal representative of the sample containing the analyte and selecting an analyte measurement sampling time based on measured temperature, physical characteristic and estimated analyte values along with temperature compensations provided for specific parameters used in the test assay.

ACCURATE ANALYTE MEASUREMENTS FOR ELECTROCHEMICAL TEST STRIP TO DETERMINE ANALYTE MEASUREMENT TIME BASED ON MEASURED TEMPERATURE, PHYSICAL CHARACTERISTIC AND ESTIMATED ANALYTE VALUE

Various embodiments for a method that allow for a more accurate analyte concentration with a biosensor by determining at least one physical characteristic signal representative of the sample containing the analyte and selecting an analyte measurement sampling time based on measured temperature, physical characteristic and estimated analyte values. 1. An analyte measurement system comprising: a substrate;', 'a plurality of electrodes connected to respective electrode connectors; and, 'a test strip including a housing;', 'a test strip port connector configured to connect to the respective electrode connectors of the test strip; and', 'a microprocessor in electrical communication with the test strip port connector to apply electrical signals or sense electrical signals from the plurality of electrodes during a test sequence,, 'an analyte meter including (a) start an analyte test sequence upon deposition of a sample;', '(b) apply a signal to the sample to determine a physical characteristic signal representative of the sample;', '(c) drive another signal to the sample;', '(d) measure at least one output signal from at least one of the electrodes;', '(e) measure a temperature of one of the sample, test strip, or meter;', '(f) determine a temperature compensated value for the physical characteristic signal based on the measured temperature;', '(g) derive an estimated analyte concentration from the at least one output signal at one of a plurality of predetermined time intervals as referenced from the start of the test sequence;', '(h) determine a temperature compensated value for the estimated analyte concentration based on the measured temperature;', '(i) select an analyte measurement sampling time point or time interval with respect to the start of the test sequence based on (1) the temperature compensated value of the physical characteristic signal and (2) the temperature compensated value of the estimated analyte concentration;', '(j) calculate an analyte concentration ...

Systems and methods for detection and quantification of analytes

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. In some embodiments, the reader component communicates with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

Analyte Monitoring Device and Methods of Use

In aspects of the present disclosure, a no coding blood glucose monitoring unit including a calibration unit is integrated with one or more components of an analyte monitoring system to provide compatibility with in vitro test strip that do not require a calibration code is provided. Also disclosed are methods, systems, devices and kits for providing the same. 1. An apparatus , comprising:an analyte sensor interface configured to receive an in vitro analyte sensor, wherein the in vitro analyte sensor generates an analyte signal from a fluid sample; anda processor operatively coupled to a data receiver and the analyte sensor interface, the processor configured to recognize the in vitro analyte sensor without a user input when the in vitro analyte sensor is received in the analyte sensor interface and is a no-coding in vitro analyte sensor, and to retrieve a universal calibration parameter when the recognized in vitro analyte sensor is the no-coding in vitro analyte sensor.2. The apparatus of claim 1 , wherein the analyte sensor interface comprises a first contact structure and a second contact structure configured to contact the in vitro analyte sensor.3. The apparatus of claim 1 , wherein the in vitro analyte sensor is a calibration-adjusted in vitro analyte sensor.4. The apparatus of claim 1 , wherein the universal calibration parameter is stored in a memory operatively coupled to the processor claim 1 , and includes a universal calibration code.5. The apparatus of claim 4 , wherein the universal calibration parameter stored in the memory is a standard calibration code claim 4 , and the in vitro analyte sensor is manufactured to fit the standard calibration code.6. The apparatus of claim 1 , further including a data receiver operatively coupled to the processor and configured to receive data relating to analyte levels from an analyte sensor in fluid contact with interstitial fluid.7. The apparatus of claim 6 , wherein the analyte sensor comprises a plurality of ...