STRIP FOR MEASURING BLOOD LIPIDS

Specifically hereinafter of the present invention embodiment with reference to the drawing objects for building more detailed as follows. However the present invention refers to in the embodiment described herein is not limited to the form and the other disapproval.

The specification "measured" in measuring layer blood layer and the reaction portion it is, upper cover of an opened window, protrusion, upper substrate can be substrate and opening window.

The specification is distributed uniformly spread in biological sample "also uniform spreading" like extent said substrate.

The present invention refers to measuring layer (300) of measuring region for exposing the upper open window (210) and said upper open window (210) along an edge of lower substrate (400) projecting combined with molded protrusions (220) includes a lower substrate (400) is combined with an upper cover (200);

Said top cover (200) of projections (220) surrounds an outer circumference of said projection (220) are formed in the depressions (410) which said top cover (200) which engages with an lower substrate (400); and

Said top cover (200) on said lower substrate (400) in the combination are said lower substrate (400) of an indentation (410) arranged on top and said top cover (200) of projections (220) pressed by and, reaction with whether a biological sample for measuring layer (300); including a blood of lipid assay strip (100) in,

Said measuring layer (300) is inserted in said not top cover (200) on said lower substrate (400) in the combination said projection (220) of bottom said depressions (410) between the bottom of the protrusion (500) is 0. 5 - 0. Characterized in 8 mm strip of lipid assay in blood (100) a number substrate.

Said blood lipid is total cholesterol, triglyceride and high cholesterol ultracentrifuged consisting of one or more selected from the group consisting of be a.

Said measuring layer (300) of projections (220) contact surface of said projection (220) and depressions (410) compacted by a biological sample measuring layer (300) can be uniformly purge of all directions.

Figure 1 shows a strip of the present invention for measuring the blood and also one in the embodiment according to (100) dB decomposition of are disclosed.

Figure 2 shows a strip of the present invention for measuring the blood and also one in the embodiment according to (100) dB of are disclosed.

Figure 3 shows a strip of the present invention for measuring the blood and also one in the embodiment according to (100) measurement of a section of an area are disclosed.

1 Of the present invention with reference to the blood and also for measuring strip (100) a top lid (200), lower substrate (400) and measuring layer (300) having a predetermined wavelength.

In the blood of the present invention for measuring strip (100) lower substrate (400) most located below, lower substrate (400) of an indentation (410) measuring top layer (300) is situated, lower substrate (400) on the top cover (200) which is positioned by the top cover (200) and a lower substrate (400) binding and after measuring layer (300) can be arranged.

The measured reference cross-sectional drawing of Figure 3 of top cover (200) and a lower substrate (400) upon top cover (200) of projections (220) is said lower substrate (400) of an indentation (410) to either accept or refuse, the projection (220) of the bottom department depressions (410) does not contact the bottom of case spaced intervals (500) is for example about 0. 5 - 0. Implementation being 8 mm. The projection (220) of bottom depressions (410) disposed between the bottom of said measuring layer (300) of projections (220) suitable contact surface pressure can be pressed. Said protrusion (500) is said measuring layer (300) is inserted in said not top cover (200) on said lower substrate (400) in the combination said projection (220) of bottom said depressions (410) between the bottom of the protrusion (500) means other.

Said measuring layer (300) of projections (220) suitable contact surface pressure by being pressed, measuring layer (300) from a biological sample such as blood it became point the central part of the measuring layer (300) with reference to the direction of the central part of the elastic sheet can be wafted all directions uniformly. Said measuring layer (300) of projections (220) contact surfaces measuring layer (300) is the top cover of projections (220) can be lessen the means in contact with.

Measuring layer (300) of projections (220) contact surface of the pressed switch is not properly measuring layer (300) when the central part of the droplets from a biological sample from a biological sample from a central portion penetrating direction when diffusion, the displayed flow rate is slowed down each periphery in the same direction of a biological sample edge diffusion can differ each other flow rate direction can be finely cross-sectional area. The biological sample measuring layer (300) from a central portion of the edge of all directions uniformly or homogeneous purge does not leak can be, from a biological sample measuring layer (300) sends all the areas of the measuring instrument measures the amount of the blood supplied when not using can mark. The biosample measuring layer (300) drop grudge behind the central part of the measuring layer (300) spreads uniformly all portions of accomplishing.

Measuring layer (300) is deflectable under pressure cross-sectional area (U=flow rate, Q=flow, A=cross-sectional area) U=Q/A reduced the cross-sectional area of formula according through biological sample the flow rate is set at the polarization component. Measuring layer (300) of projections (220) the same as the direction of the edge of the cross-sectional area reduced regularly compressing a contact surface to be coated. The rate of fluid flow passing the edge each direction and therefore the flow rate becomes a biological sample measuring layer (300) when the edge of diffusion, each edge of the reduced flow rate constant cross-sectional area which is not a biological sample measuring layer (300) can be equally spreading all portions of.

the measuring layer (300) of projections (220) contact surface pressing can be variable degree uniform diffusion of a biological sample, the victims of the present invention cover the upper cover comparison test (200) and a lower substrate (400) upon projection (220) of bottom depressions (410) between about 0 the bottom of the protrusion. 5 - 0. When pressing strength of 8 mm is applied to, a biological sample through supporting the biological sample can be markedly improves the reliability of the measurement result of the uniform spreading was found. More specifically, said protrusion is 0. 55 - 0. 75 Mm and, more particularly than 0. 6 - 0. 7 Mm and, most specifically 0. 62 - 0. 68 Mm are disclosed.

In the blood of the present invention hereinafter for measuring strip (100) to operate with detailed description as follows.

Said top cover (200) at the bottom substrate (400) is coupled with, measuring layer (300) of measuring region for exposing the upper open window (210) and said upper open window (210) along an edge of lower substrate (400) projecting combined with molded protrusions (220) having a predetermined wavelength. Said upper open window (210) such as blood through the biosample strip (100) by the droplets can be incorporated into the disclosed. In addition said projection (220) and holds layer (300) mounted to the press (press) it acts as a negative, usually an upper-opened window (210) regardless of the shape of shaped and can be polygonal, circular or amorphous can be, specifically can be circular.

Upper open window (210) (when a shape circular diameter) pressure is applied to the width of a projection (220) upper newly opened window (210) proportional to the distance to the center of, 1. A biological sample within 5 provided 10 mm uniform spreading is also provided to adjust the thicknesses were identified. The, upper open window (210) widths of the 1. 5-a 10 mm and, more specifically 1. 5 A-7mm and, more particularly than 1. 5-a 5 mm and, most specifically 1. 5 - 3. Implementation being 5 mm.

In addition of Figure 1 top cover (200) referencing said bottom view of the top cover (200) at the bottom substrate (400) for engagement fastening rigid with, lower substrate (400) direction combined with possibility hook (hook) (230) can be with.

Said lower substrate (400) a top lid (200) which engage with an, upper cover (200) of projections (220) surrounds an outer circumference of said projection (220) are formed in the depressions (410) having a predetermined wavelength. Said depressions (410) the measuring layer (300) is placed and fixed is can be, measuring layer (300) is disposed after top cover (200) and a lower substrate (400) the bottom of the top cover (200) of projections (220) is depressions (410) in which the depressions inserted into (410) handle measuring layer (300) of projections (220) can be pressing contact surface. Said depressions (410) a bottom surface section of, i.e. the floor is limited to can be a flat form by methods are not correct. In the embodiment of the present invention reference of Figure 3 cross-sectional drawing the depressions in one (410) (not shown) may be formed in additional number 2 in depressions, a stepped cross-section can be formed. I.e. said depressions (410) once the surface shape of 'a' implementation being form.

The number 2 formed depressions corresponding to the projecting portion (220) (not shown) is formed into a further projection also sequentially narrower number 2 'V' shape can be. The projection (220) is depressions (410) by part number 2 number 2 simultaneously inserted member and condenses, stepped annular coupling end can be formed. In this case the projection of bottom protrusion number 2 number 2 bottom depressions can be at regular intervals.

Said lower substrate (400) of an indentation (410) of the bottom department opening window (420) can be a. The top cover (200) and a lower substrate (400) in the combination top cover (200) of newly opened window (210) at the bottom substrate (400) height of window (420) rotates on the middle of the, measurement layer interposed therebetween (300) of measurement in the same position in the side of the lower surface portion strip (100) made of a lower open can be exposed.

In addition said lower substrate (400) a top lid (200) for rigid engagement with cancerous hook (430) can be with.

Measuring layer (300) is lower substrate (400) of an indentation (410) to the piston are connected with the lower substrate (400) on the top cover (200) stacked when assembled, top cover (200) not covered by lower substrate (400) portion, i.e. lower substrate (400) the user hole generating unit as well as a handle (440) is connected to the edifice.

For measuring the blood and said strip (100) is said lower substrate (400) of an indentation (410) in said measuring layer (300) further comprises a bed (not shown) can be fixed. Said measuring layer (300) is said lower substrate (400) of an indentation (410) may be affecting the measurement result of the measuring is a high in lower substrate (400) of an indentation (410) measuring layer (300) fixing need to be disclosed. The double-sided tape such as 3M e.g. fixed depressions (410) bottom measuring layer (300) introduced between the measured layer (300) to prevent transfer of can.

The, said upper cover (200) of projections (220) of bottom said lower substrate (400) of an indentation (410) bottom spaced intervals (500) projections (220) can be replaced by fixed bed of bottom spacing between, protrusion (500) to 0. 5 - 0. Subjecting the reaction mixture to 8 mm can be maintained said measuring layer (300) is pressed with the same pressure as can be.

In addition said top cover (200) or said lower substrate (400) is a third different color depending on the type of the blood in the blood when the kind of a portion said belt line can be measured. For example but not limited to, measuring total cholesterol top cover (200) or lower substrate (400) is red, triglycerides measuring includes an upper cover (200) or lower substrate (400) is ultracentrifuged yellow or high specific gravity measuring cholesterol top cover (200) or lower substrate (400) can be painted like the blue. In this case, measured in the blood and top cover (200) or lower substrate (400) can be judged in a section of the color of the blood in the type of directly.

Said reference 2 also the top cover (200) on said lower substrate (400) are interconnected by means of the coupling can be secured to the laminate bond. Coupling the upper cover (200) and a lower substrate (400) when measuring instruments as the coupling strength is strong even during the measurement using said blood through the projection (220) is measured layer (300) of projections (220) can be compressed to contact surface stable and consistent measurement can be slider is moved to.

Said measuring layer (300) is introduced in the biosample diffusion layer (310), said diffusion layer (310) by the mobile number lipids from biological sample screening material separate layer (320) and said separate layer (320) blood lipids by number criterion are filtered out material reacts with the reaction layer (330) can be a.

As shown in one of the present invention 1 also in the embodiment according to measuring layer (300) on a diffusion layer (310), separate layer (320) and reaction layer (330) can be embodied in the form of laminated thereon. Generally pressed before said measuring layer (300) has a thickness of 0. 85 - 0. Implementation being 95 mm.

Said diffusion layer (310) a biological sample such as blood is introduced quickly and uniformly spread diffuse to the. In the embodiment of the present invention in one said diffusion layer (310) is further provided such as for example polyester or woven material or fabric (woven material) 16th June, pledget, mono (non non-woven fabric) from a nonwoven material such as implementation being.

Said separate layer (320) on a diffusion layer (310) and retard, diffusion layer (310) are spread out in the biosample i.e., separating material number can be lipids from blood. Said number material comprising red blood lipids such as blood etc. and can be.

In the embodiment of the present invention in one said separate layer (320) to design the entire apparatus and can then be empirically is about 80 - 90%. In addition said separate layer (320) is number 1 and number 2 can be contained in separate layer separation, separation layer from undesirable blood cell number 1 number 2 main exhaust exhaust can be a separate layer.

Said separate layer (320) includes a paper pad, glass fiber, polyester, nitrocellulose and poly - alcoholic beverage gun four with [thu one or more may be selected from the group consisting, in the embodiment of the present invention measured in blood lipids material one number can be precipitating reagents. A biological sample measuring layer (300) measured in the blood when introduced into the biosample, e.g. total cholesterol, triglyceride or cholesterol ultracentrifuged number one of high specific gravity remaining passivating material layer (320) criterion are filtered out by blood reaction layer (330) can be introduced into. The separation layer (320) is 0. May have a diameter of 5 a-2um, thickness 0. 10 - 0. 40 Mm, more specifically 0. 20 - 0. 40 Mm, most specifically 0. 30 - 0. May have a thickness of 35 mm.

Said reagents include aggregation number, or a mixture of these precipitation number can be a separate layer (320) and distributed throughout the increase, fixed or can be impregnated in the form. E.g. said reagents are measured total cholesterol and triglycerides agglomerate when number is lectin (Lectin), cationic polymer or polysaccharide (saccharide) can be composed. For example lectin PHA (phytohemagglutinin), concanavalin A, for producing a number of PWM (pokeweed mitogen) for detecting influenza () but are not disclosed. Poly (diallyldimethylammonium chloride) of cationic polymer for example when there is, in the case of transcription (saccharide) monosaccharide, disaccharide or polysaccharides can be one or more. The lectin (Lectin) number is characterized agglomerate when cholesterol ultracentrifuged high specific gravity, cationic polymer or polysaccharide (saccharide) can be composed of, for example lectin PHA (phytohemagglutinin), concanavalin A, for producing a number of PWM (pokeweed mitogen) for detecting influenza () but are not disclosed. The removal agents e.g. poly (diallyldimethylammonium chloride) and is, in the case of transcription (saccharide) monosaccharide, disaccharide or polysaccharides can include one or more, e.g. sorbitol, sugar, oligosaccharide to number one but not disclosed. Precipitation (LDL) cholesterol in the blood has a curved number multiple selectively precipitated and ultracentrifuged function, a sulfonated polysaccharide, heparin, acid (PTA) and lead acid battery comprising one or more or, group 2 can be one of these cations.

Said reaction layer (330) comprises a separate layer (320) and retard, separate layer (320) lipids in blood and other materials react with biological sample number exhaust measurement object, i.e. to cause a change in color can be reagents.

Reaction layer (330) is biological data to obtain said separate layer (320) measurement object number lipids in blood and criterion are filtered out material can be performing an electrochemical reaction. Reaction layer (330) is prevented measurement object which lipid reagents, the reagents are reacted layer (330) is impregnated in or present stationary state.

In the embodiment of the present invention e.g. when measuring high specific gravity according to one ultracentrifuged cholesterol, cholesterol and cholesterol fatty acid is decomposed into a number s on cholesterol response after is, oh number oxy cholesterol, cholesterol, it ladles and the jade it is sour, oh on oxygen reaction away the color blue color reagent reacts to hydrogen peroxide number up reaction using cholesterol can be quantified.

In the embodiment of the present invention according to one when measuring total cholesterol, cholesterol esters and method number generated by the reaction of cholesterol and cholesterol oxy is, oh number generated hydrogen peroxide number reagents react with oxygen by reacting it ladles and the jade it is sour, oh on blue can be quantifying the cholesterol via reaction with symptoms.

In the embodiment of the present invention according to one when measuring triglycerides, glycerol in the presence of glycerol ATP generated react with a lysine on lung oh monoglyceride tree number for development products so produced number oxy is, oh lithium bromide, hydrogen peroxide water oxygen reaction reagents by reacting it ladles and the jade it is sour, oh number generated on the optical change can be observed through quantifying triglycerides.

In of the present invention in the embodiment, said measuring layer (300) does not limited to the configuration of the, comprising a variation can be various. For example bio-specimen sample absorbance or each layer in order to improve the interaction between transfer rate than, between each layer further comprises additional layers can be. Specifically additional diffusion layer (310) inserted between each layer circumference be spread more quickly.

In the blood of the present invention for measuring strip (100) at the same time measuring various biological sample information can be, and is for measuring the blood of strip (100) to said upper cover (200) of newly opened window (210), projection (220) and a corresponding lower substrate (400) of an indentation (410), opening window (420) including a measuring region formed with plural implemented by process from. In the embodiment of the present invention as shown in the 1 and 2 also in one, one strip for one or more of lipid assay (100) and three measuring areas, measuring layer (300) also for measuring total cholesterol, triglyceride ultracentrifuged for measuring for measuring cholesterol can be formed during and high. The three measuring region in total cholesterol, triglyceride and high cholesterol can be simultaneously measuring during ultracentrifuged.

In addition an upper opened window (210), projection (220) and depressions (410) connected through the newly opened window have an (420) has an, an upper opened window (210) in the biosample droplets through by a plurality of detector material response for each underlying whether newly opened window (420) process from the brightness.

Hereinafter of the present invention to aid in understanding a number at one preferred embodiment, the present invention is exemplified in the embodiment of the present invention is to a scrap vertical range changes and modifying feature category and in various angular positions to which it is apparent that in conventional, such change and modification of relay belonging to natural claim also are disclosed.

<In the embodiment and Comparison example>

1. Upper open window diameter blood diffusion of confirming influence

Newly opened window upper diameter of 1. 5, 2, 2. 5, 3, 3. 2 And 3. Each database 5 mm was formed. A servicing through blood is immediately opened window also 4 upper top diameter of blood (blood inlet) independently of the measuring layer whispered about throughout the newly opened window uniformly purge which the inhibin receptor.

2. Deriving optimal protrusion

In the blood of the present invention for measuring strip top cover of projections between measuring layer is formed on the bottom of the depression of lower substrate bottom protrusion according to uniform diffuseness biological sample for measuring, lipid measurement object total cholesterol, triglyceride or cholesterol ultracentrifuged high specific gravity to choose and, 0 said protrusion. 65 Mm (in the embodiment 1), 0. 45 Mm (comparison example 1) or 0. (Comparison example 2) blood 85 mm strip of lipid assay by small number-gate. Work grudge said number in the embodiment 1, blood levels of comparison example 1 and comparison example 2 top cover strip of lipid assay of each newly opened window by observing blood flow through blood samples after introducing droplets when the developing, total cholesterol, triglyceride or high specific gravity to the results for the cholesterol ultracentrifuged shown to table 1.

Said CV % coefficient of variation is represented by average and standard deviation to perform meaning, reproducibility can be used as an indicator, low CV % measurement reproducibility can comprise removing big.

As shown in the table 1, in the embodiment 1 in the blood such as top cover strip for measuring projection of bottom protrusion between 0 bottom of the depression of the lower substrate. When 65 mm, less than 5% cholesterol and triglycerides CV % value when, in the case of 7% or less than 1 as compared to example 2 and high specific gravity ultracentrifuged cholesterol compared with two-stage reduction is result precursor, resolution (resolution) index representing the highest shown by calculating values are also excellent resolution in addition can be know.