WO2023162095A1 - 血液検査デバイス - Google Patents

血液検査デバイス Download PDF

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Publication number
WO2023162095A1
WO2023162095A1 PCT/JP2022/007627 JP2022007627W WO2023162095A1 WO 2023162095 A1 WO2023162095 A1 WO 2023162095A1 JP 2022007627 W JP2022007627 W JP 2022007627W WO 2023162095 A1 WO2023162095 A1 WO 2023162095A1
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WIPO (PCT)
Prior art keywords
substrate
blood
test device
plasma separation
plasma
Prior art date
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PCT/JP2022/007627
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English (en)
French (fr)
Japanese (ja)
Inventor
丞謙 金
尚志 伊藤
知彦 江面
Original Assignee
セルスペクト株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by セルスペクト株式会社 filed Critical セルスペクト株式会社
Priority to JP2024502339A priority Critical patent/JPWO2023162095A1/ja
Priority to PCT/JP2022/007627 priority patent/WO2023162095A1/ja
Priority to EP22813388.0A priority patent/EP4261539B1/en
Priority to TW111150592A priority patent/TWI829491B/zh
Priority to SA522441966A priority patent/SA522441966B1/ar
Publication of WO2023162095A1 publication Critical patent/WO2023162095A1/ja
Priority to US18/796,295 priority patent/US20240390888A1/en

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/525—Multi-layer analytical elements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16—Reagents, handling or storing thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0681—Filter
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/069—Absorbents; Gels to retain a fluid
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips

Definitions

  • the present invention relates to a blood test device for measuring the presence or concentration of a specific substance in blood.
  • blood tests are widely used to analyze the presence or absence or concentration of specific substances contained in blood. For example, by analyzing the contents of various components contained in plasma in blood, it is possible to diagnose the organ functions of a subject.
  • blood which is a sample
  • plasma or serum which is a liquid component
  • cells which are solid components
  • a certain amount of blood for example, 5 mL or more
  • a doctor, nurse, or clinical laboratory technician must collect blood from the subject. Therefore, general blood tests can only be performed at medical institutions or specialized testing institutions equipped with expensive analytical instruments such as centrifuges and power supply equipment for operating them.
  • the burden on the medical staff who collects blood is also large. In other words, a general blood test imposes a heavy burden not only on the subject but also on the medical institution, and the cost is also high.
  • US Pat. No. 6,200,400 discloses an anisotropic membrane containing a specific chromogenic reagent system for analytes and having a relatively small perforated side defining a test surface and an opposite relatively large perforated side defining a sample receiving surface.
  • a reagent strip with said transfer medium is disclosed.
  • a testing device in which a plasma separation section that is made of a porous member and separates plasma by allowing blood to pass through and a reagent phase that is a dry reagent phase impregnated with a reagent are laminated, Plasma is impregnated from one side of the reagent phase and the color reaction generated by the plasma reaching the other side of the reagent phase is observed.
  • a plasma separation section that is made of a porous member and separates plasma by allowing blood to pass through and a reagent phase that is a dry reagent phase impregnated with a reagent are laminated
  • Plasma is impregnated from one side of the reagent phase and the color reaction generated by the plasma reaching the other side of the reagent phase is observed.
  • the entire surface of the reagent phase must be brought into contact with the necessary and sufficient amount of plasma. This is because if the amount of plasma is insufficient, the sensitivity of the color reaction obtained by contact between the plasma and the reagent phase will be low, and the reaction may not be observed. Alternatively, if the amount of plasma is insufficient, there is also the problem of uneven reaction occurring in the reagent phase, resulting in reduced reproducibility of the test. On the other hand, if the amount of plasma is too large, the plasma will overflow from the reagent phase, and the plasma will wrap around the surface from the side of the reagent phase, resulting in a non-uniform reaction.
  • the present invention has been made in view of the above, and provides a blood test device that can be used in a simple manner, has good reliability and reproducibility, and can obtain stable determination results. With the goal.
  • a blood test device brings blood plasma separated from blood into contact with a dry reagent phase impregnated with a reagent, thereby causing a change in the dry reagent phase.
  • a blood test device for measuring the presence or concentration of a specific substance contained in the blood based on color reaction, the first substrate having a first opening to which blood is added; a second substrate arranged to face the first substrate and provided with a second opening for observing the color reaction, and the second substrate between the first and second substrates a dry reagent phase laminated so as to be partly exposed from the second opening; a plasma separation section formed of a porous sheet material and laminated on the dry reagent phase; a diffusion layer formed of a sheet material made of fibers having a of the surface, the region outside the portion in contact with the dry reagent phase is adhered to the second substrate.
  • the ratio of the volume of the plasma separation section to the volume of the dry reagent phase may be 1.6 times or more and 3.7 times or less.
  • a plurality of the second openings are provided, a plurality of the dry reagent phases are provided, and the ratio of the volume of the plasma separation unit to the sum of the volumes of the plurality of dry reagent phases is 1.6 times. It may be 3.7 times or less.
  • the ratio may be 2.0 times or more and 3.1 times or less.
  • the blood test device is arranged between the first substrate and the second substrate, and is configured to form a space having a predetermined height between the first substrate and the second substrate.
  • a spacer may be further provided, wherein the dry reagent phase, the plasma separation section, and the diffusion layer are arranged in the space, and the height of the spacer is equal to the height of the diffusion layer before assembling the blood test device. , the thickness of the plasma separation part, and the thickness of the dry reagent phase.
  • the height of the spacer may be 0.65 times or more and 0.9 times or less of the sum.
  • the plasma separation section may include a polysulfone membrane or an asymmetric polysulfone membrane.
  • a blood test device that can be used in a simple manner, has good reliability and reproducibility, and can obtain stable determination results.
  • FIG. 1 is a perspective view showing a blood test device according to an embodiment of the present invention (observation section side);
  • FIG. 1 is a perspective view (blood adding section side) showing a blood test device according to an embodiment of the present invention
  • FIG. FIG. 3 is an exploded perspective view of the blood test device shown in FIG. 2;
  • FIG. 3 is a partially enlarged cross-sectional view of the blood test device shown in FIG. 2;
  • FIG. 10 is a graph showing average colorimetric sensitivity values for experimental test devices;
  • FIG. FIG. 4 is a graph showing CV values of colorimetric sensitivity in an experimental inspection device;
  • FIG. FIG. 11 is an exploded perspective view of a blood test device according to a modified example of the embodiment of the present invention;
  • the blood test device described below brings plasma separated from blood into contact with a dry reagent phase impregnated with a reagent. It is used to measure the presence or concentration of substances such as A measurable test item is not particularly limited as long as it is a component contained in blood plasma and exhibits a color reaction with a predetermined reagent. Specific examples of inspection items include AST, ALT, ⁇ -GT, neutral fat, HDL cholesterol, LDL cholesterol, blood sugar, HbA1c, and minerals such as zinc and magnesium.
  • FIG. 1 and 2 are perspective views showing the blood test device according to the first embodiment of the present invention. Among them, FIG. 1 shows the state of the blood test device viewed from the observation section side, and FIG. 2 shows the state viewed from the blood adding section side.
  • FIG. 3 is an exploded perspective view of the same blood test device.
  • FIG. 4 is a partially enlarged sectional view of the same blood test device.
  • a blood test device 10 (hereinafter also simply referred to as a test device) 10 according to the present embodiment includes a first substrate 11 and a second substrate 12 arranged to face each other, and a first A diffusion layer 13 laminated between a substrate 11 and a second substrate 12, a plasma separation section 14, and a reagent phase 15 are provided.
  • the first substrate 11 and the second substrate 12 are formed of a thin sheet material made of a resin material such as PET (polyethylene terephthalate).
  • a resin material such as PET (polyethylene terephthalate).
  • the material of the first substrate 11 and the second substrate 12 is not limited to resin, and the shape of the inspection device 10 can be maintained, and the sample blood or plasma may permeate, or the Any material may be used as long as it is surface-treated so as not to react with liquids.
  • the first substrate 11 and the second substrate 12 may be formed of cardboard whose surface is water-repellent.
  • the first substrate 11 is formed with a blood addition portion 111, which is an opening to which blood, which is a sample, is added.
  • the shape of the blood addition portion 111 is an elliptical shape, but the shape is not particularly limited, and any shape that allows addition of blood may be used. Specifically, a rectangular shape, an oval shape, or the like can be mentioned.
  • an alignment opening 112 may be formed in the first substrate 11 .
  • An observation portion 121 that is an opening for observing the color reaction of the reagent phase 15 is formed on the second substrate 12 .
  • the shape of the observation portion 121 is square in this embodiment, the shape is not particularly limited, and may be a circle, an ellipse, or the like. From the viewpoint of facilitating observation of the color reaction, it is preferable that the shape of the observation portion 121 is similar to the shape of the reagent phase 15 and that the area of the reagent phase 15 exposed from the observation portion 121 is made as large as possible.
  • an alignment opening 122 may be formed in the second substrate 12 .
  • the diffusion layer 13, the plasma separation section 14, and the reagent phase 15 are prevented from being deformed, and these three layers are kept in contact with each other. can do.
  • the first substrate 11 and the second substrate 12 may be formed of two plates separated from each other, or may be formed by bending one elongated plate. .
  • a spacer 16 is arranged between the first substrate 11 and the second substrate 12 .
  • the spacer 16 forms a space 10a with a predetermined height between the first substrate 11 and the second substrate 12. As shown in FIG. In this space 10a, a reagent phase 15, a plasma separation section 14, and a diffusion layer 13 are layered in this order from the second substrate 12 side.
  • the spacer 16 is made of a plate material, such as a resin material such as PET, which is not easily deformed (compressed) by pressing in the thickness direction and is not permeated with the sample blood or plasma and does not react with these liquids. formed.
  • the spacer 16 is adhered to the first substrate 11 and the second substrate 12 with double-sided tape 17.
  • the method of fixing the spacers 16 to the first substrate 11 and the second substrate 12 is not limited to the double-sided tape 17, and liquid or paste adhesive may be used, or thermocompression may be used. The point is that the height of the space 10a can be kept constant by the spacers 16. FIG.
  • the thickness of the spacer 16 that is, the height of the space 10a, is smaller than the sum of the thickness of the diffusion layer 13, the thickness of the plasma separation section 14, and the thickness of the reagent phase 15 before the inspection device 10 is assembled. . That is, when the test device 10 is assembled, the first substrate 11 and the second substrate 12 apply a constant pressure to the diffusion layer 13, the plasma separation section 14, and the reagent phase 15, and are in close contact with the adjacent layers. is maintained.
  • the thickness of the spacer 16 is preferably 0.65 to 0.9 times the sum, and more preferably 0.7 to 0.85 times the sum.
  • the plasma separation section 14 and the reagent phase 15 may be compressed too much and cause clogging. Moreover, if the thickness of the spacer 16 is too large (for example, more than 0.9 times) with respect to the above sum, it becomes difficult to keep the diffusion layer 13, the plasma separation section 14, and the reagent phase 15 in close contact with each other.
  • the diffusion layer 13 is formed of a sheet-like woven member of hydrophilic fibers, and is arranged so as to be partially exposed from the blood addition portion 111 provided on the first substrate 11 .
  • the diffusion layer 13 quickly guides the blood added to the blood addition portion 111 to a wide range in the surface direction by capillary action, and acts to uniformly permeate one surface of the plasma separation portion 14 .
  • the diffusion layer 13 is made of hydrophilic polyester in a plain weave.
  • the diffusion layer 13 is adhered to the first substrate 11 with a double-sided tape 17 attached around the blood addition portion 111 .
  • the diffusion layer 13 may be adhered to the first substrate 11 using an adhesive or the like instead of the double-sided tape 17 .
  • the plasma separation part 14 is formed of a porous sheet material, traps cell components in the blood permeated on one surface, and separates plasma by allowing liquid components to pass through in the film thickness direction.
  • a porous polymer membrane such as a polysulfone (PS) membrane or an asymmetric PS membrane can be used.
  • PS polysulfone
  • asymmetric PS membrane has good blood separation performance, and even if the membrane is as thin as several millimeters, it is possible to obtain colorless and transparent plasma that is not mixed with whole blood or hemolyzed blood.
  • an asymmetric PS membrane is used as the plasma separation section 14 .
  • the asymmetric PS film has directivity and is arranged in a direction that allows liquid to pass from the first substrate 11 to the second substrate 12 .
  • a member having a multi-layer structure in which a glass fiber membrane is combined with a PS membrane or the like may also be used as the plasma separation membrane 14 .
  • the plasma separation part 14 is arranged so that the surface (first surface) on the first substrate 11 side is in contact with the diffusion layer 13 and the surface (second surface) on the second substrate 12 side is in contact with the reagent phase 15 . It is In addition, of the second surface of the plasma separation unit 14 , the area outside the portion in contact with the reagent phase 15 is adhered to the second substrate 12 with double-sided tape 17 . As a result, plasma exudation from the outer region can be suppressed, reaction unevenness of the reagent phase 15 caused by plasma exudation can be prevented, and the plasma can be efficiently transferred from the plasma separation unit 14 to the reagent phase 15. can be supplied.
  • the plasma separation unit 14 may be adhered to the second substrate 12 using an adhesive or the like instead of the double-sided tape 17 . In either case, by bringing the outer region into close contact with the second substrate 12 to eliminate the gap between the two, unintended seepage of plasma from the plasma separation section 14 can be suppressed.
  • the reagent phase 15 is a dry reagent phase obtained by impregnating filter paper (chromatography paper, etc.) with a reagent corresponding to an inspection item and drying it.
  • the reagent phase 15 is adhered to the second substrate 12 with a double-sided tape 17 attached around the observation portion 121 .
  • an adhesive or the like may be used instead of the double-sided tape 17 .
  • the reagent phase 15 reacts with a predetermined substance contained in plasma that has passed through the plasma separation section 14 and develops a color. This color reaction can be visually observed from the observation part 121 side by sufficiently permeating the reagent phase 15 with blood plasma.
  • the ratio of the volume of the plasma separation section 14 to the volume of the reagent phase 15 is preferably 1.6 times or more and 3.7 times or less, and 2.0 times or more and 3.1 times before the test device 10 is assembled. It is more preferable to make it twice or less. If this volume ratio is too small (for example, less than 1.6 times), the amount of plasma retained in the plasma separation unit 14 will be less than the volume of the reagent phase 15, so the plasma supplied to the reagent phase 15 will be It will dry up quickly. As a result, the drying of the reagent phase 15 progresses, making it difficult to observe a stable color reaction.
  • volume ratio is too large (for example, more than 3.7 times), an excessive amount of plasma will be supplied to the reagent phase 15, causing uneven color reaction in the reagent phase 15, Leakage may occur, reducing the reliability and reproducibility of test results.
  • a fingertip or the like is pricked to bleed to form a blood pool.
  • the blood adding portion 111 side of the test device 10 is directed downward, and the blood adding portion 111 is brought into direct contact with a blood pool formed on a fingertip or the like.
  • the testing device 10 is removed from the fingertip or the like.
  • the concentration of the test item is estimated by comparing the color development of the reagent phase 15 with the reference color.
  • a simple liquid sampling tool may be used instead of directly contacting the test device 10 with the blood pool.
  • blood is held by bringing the tip of a cylindrical liquid sampling tool into contact with the blood pool, and the blood is transferred by bringing this tip into contact with the blood adding section 111 .
  • the diffusion layer 13 is provided in the blood addition portion 111. Therefore, when blood is added to the blood addition portion 111, the blood flows along the diffusion layer 13 and spreads in the plane direction. spread quickly to Therefore, even if blood is added to only a part of the blood adding portion 111, the entire surface of the plasma separating portion 14 can be soaked with blood quickly and uniformly. As a result, plasma separation progresses almost simultaneously in the planar direction of the plasma separation section 14 , and the entire surface of the reagent phase 15 in contact with the plasma separation section 14 can be permeated with a substantially uniform amount of plasma. As a result, variations in reaction in the reagent phase 15 are suppressed, and test results with good reliability and reproducibility can be obtained.
  • the area outside the portion in contact with the reagent phase 15 is adhered to the second substrate 12, so plasma is retained in the reaction area.
  • the plasma separation membrane 14 can be brought into close contact with the reagent phase 13 to promote permeation of plasma into the reagent phase 15 .
  • the ratio of the volume of the plasma separation section 14 to the volume of the reagent phase 15 is preferably 1.6 times or more and 3.7 times or less, more preferably 2.0 times or more and 3.1 times.
  • the plasma retained in the plasma separation unit 14 after being separated from the blood in the plasma separation unit 14 is continuously supplied to the reagent phase 15 .
  • the plasma is sequentially supplied from the back surface of the reagent phase 15, so that the observation unit 121 can stably operate for a certain period of time (at least several minutes to several tens of minutes). A color reaction can be observed.
  • the spacer 16 is arranged between the first substrate 11 and the second substrate 12, the diffusion layer 13, the plasma separation section 14, and the reagent phase 15 are slightly compressed in the space 10a. can be placed in As a result, these layers are in close contact with each other, so that plasma can be uniformly supplied from the plasma separation section 14 to the reagent phase 15 in the surface direction. Therefore, reaction unevenness in the reagent phase 15 can be suppressed, and the reliability and reproducibility of test results can be improved. Further, by applying a constant pressure to the plasma separation unit 14 and the reagent phase 15, the plasma retained in the plasma separation unit 14 is continuously supplied to the reagent phase 15 at a substantially constant speed. It is possible to obtain a realistic judgment result.
  • the volume ratio between the plasma separation section 14 and the reagent phase 15 is appropriately set, an appropriate amount of plasma can be added to the reagent phase without accurately measuring the amount of blood to be added. 15 can be supplied. That is, it is possible to stably obtain test results with good reliability and reproducibility based on a very small amount of blood even by a simple method of directly contacting the blood addition part 111 with a blood pool formed on a fingertip or the like. . Therefore, even in regions or countries where testing equipment is not available, subjects can perform testing by themselves, which can be useful for health management.
  • Example 10 In a device having the same configuration as the test device 10, the following experiment was conducted to measure the colorimetric sensitivity in the reagent phase by changing the ratio of the volume of the plasma separation section to the volume of the reagent phase.
  • Test device for experiments in which a reagent phase, a plasma separation part, and a diffusion layer made of the following materials are arranged between two substrates each having openings for the blood addition part and the observation part. were prepared for each size of the plasma separation part.
  • the thickness of the spacer that keeps the distance between the two substrates was 0.5 mm.
  • Reagent phase Materials Reagents for measuring glucose concentration on chromatographic paper (ingredients: piperazine-1,4-bis(2-ethanesulfonic acid) (PIPES), N-ethyl-N-(2-hydroxy-3- Test paper impregnated with sodium sulfopropyl)-3,5-dimethoxyaniline (DAOS), 4-aminoantipyrine (4-AA), mutarotase, peroxidase (POD), glucose oxidase) and dried Size: 5mm x 5mm, Thickness 0.17 mm (volume: 4.25 mm 3 )
  • Plasma separation unit Material Asymmetric polysulfone Size: 6 types of 5 mm ⁇ 4 mm, 5 mm ⁇ 5 mm, 5 mm ⁇ 6 mm, 5 mm ⁇ 7 mm, 5 mm ⁇ 8 mm, 5 mm ⁇ 9 mm, 5 mm ⁇ 10 mm, thickness is only 0.33 mm (Volume: 6.6 mm,
  • FIG. 5 is a graph showing the average colorimetric sensitivities (for R values) in the experimental test devices.
  • FIG. 6 is a graph showing CV values of colorimetric sensitivity (for R values) in an experimental test device. 5 and 6, the horizontal axis indicates the ratio of the volume of the plasma separation section to the volume of the reagent phase.
  • the smaller the CV value of the colorimetric sensitivity the less the variation in the results, that is, the higher the reproducibility of the results, and thus the higher the reliability.
  • the CV value of the colorimetric sensitivity is about 5% or less, which is relatively small variation.
  • the average colorimetric sensitivity is also within the range of 1 ( ⁇ 0.1).
  • the CV value of the colorimetric sensitivity is about 3% or less, which is even less variation.
  • the ratio of the volume of the plasma separation part to the volume of the reagent phase is not strictly limited to the above ratio, and may include a range of approximately ⁇ 10%.
  • FIG. 7 is an exploded perspective view of a blood test device according to a modification of the embodiment of the invention.
  • the blood test device 20 according to this modification is a device for testing multiple items, and includes a first substrate 21 and a second substrate 22 which are arranged to face each other with a spacer 26 interposed therebetween; It comprises a diffusion layer 23 arranged between the first substrate 21 and the second substrate 22, a plasma separation section 24, and a plurality of reagent phases 25a, 25b, 25c.
  • the materials and functions of these parts are the same as those of the first substrate 11, the second substrate 12, the diffusion layer 13, the plasma separation part 14, the reagent phase 15, and the spacer 16 in the first embodiment.
  • the first substrate 21 is formed with a blood addition portion 211, which is an opening to which blood, which is a sample, is added.
  • the shape of the blood addition portion 211 is not particularly limited, and may be a rectangle as shown in FIG. 7, an ellipse, an ellipse, or the like.
  • the second substrate 22 is formed with a plurality of observation portions 22a, 22b, and 22c, which are openings for observing the color reaction.
  • a plurality of reagent phases 25a, 25b, and 25c are arranged so as to be partially exposed from these observation portions 22a, 22b, and 22c, respectively.
  • openings 212 and 222 for alignment may be formed in the first substrate 21 and the second substrate 22, respectively.
  • the regions excluding the portions in contact with the reagent phases 25a, 25b, 25c include the regions between the reagent phases 25a, 25b, 25c. It is adhered to the second substrate 22 by tape, adhesive, or the like. This suppresses leakage of plasma from regions of the surface of the plasma separation unit 24 on the side of the reagent phases 25a, 25b, 25c, excluding portions in contact with the reagent phases 25a, 25b, 25c. In addition, it is possible to prevent liquid from flowing through the adjacent reagent phases 25a, 25b, and 25c, thereby suppressing plasma seepage between the adjacent reagent phases.
  • the ratio of the volume of the plasma separation section 24 to the sum of the volumes of the plurality of reagent phases 25a, 25b, and 25c should be 1.6 times or more and 3.7 times or less. is preferable, and 2.0 times or more and 3.1 times or less is more preferable.

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PCT/JP2022/007627 2022-02-24 2022-02-24 血液検査デバイス WO2023162095A1 (ja)

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JP2024502339A JPWO2023162095A1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html) 2022-02-24 2022-02-24
PCT/JP2022/007627 WO2023162095A1 (ja) 2022-02-24 2022-02-24 血液検査デバイス
EP22813388.0A EP4261539B1 (en) 2022-02-24 2022-02-24 Blood testing device
TW111150592A TWI829491B (zh) 2022-02-24 2022-12-29 血液檢測裝置
SA522441966A SA522441966B1 (ar) 2022-02-24 2022-12-29 جهاز اختبار دم لقياس وجود أو تركيز مواد معينة في الدم
US18/796,295 US20240390888A1 (en) 2022-02-24 2024-08-07 Blood test device

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US20240390888A1 (en) 2024-11-28
TW202348198A (zh) 2023-12-16
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EP4261539B1 (en) 2024-09-11
SA522441966B1 (ar) 2024-10-09

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