WO2014142181A1 - 検査キット - Google Patents
検査キット Download PDFInfo
- Publication number
- WO2014142181A1 WO2014142181A1 PCT/JP2014/056520 JP2014056520W WO2014142181A1 WO 2014142181 A1 WO2014142181 A1 WO 2014142181A1 JP 2014056520 W JP2014056520 W JP 2014056520W WO 2014142181 A1 WO2014142181 A1 WO 2014142181A1
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- WIPO (PCT)
- Prior art keywords
- region
- substance
- labeling substance
- liquid sample
- backflow prevention
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Classifications
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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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
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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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54366—Apparatus specially adapted for solid-phase testing
- G01N33/54386—Analytical elements
- G01N33/54387—Immunochromatographic test strips
- G01N33/54388—Immunochromatographic test strips based on lateral flow
Definitions
- the present invention relates to an inspection kit by immunochromatography.
- an immunochromatography method is known as an immunoassay method for detecting a specific substance to be detected using a specific reaction such as an antigen-antibody.
- Immunochromatography is an inspection method widely used as POCT (Point Of Care Test).
- POCT Point Of Care Test
- POCT is a test performed in the vicinity of a patient, rather than sending the patient's sample to a testing institution so that a doctor can immediately determine the test result and perform rapid treatment.
- immunochromatography is used for the diagnosis of infectious diseases derived from bacteria and viruses, especially infants with low immunity, such as infants and the elderly, and infectious diseases that require immediate treatment.
- highly sensitive detection is required.
- test kit is used for measurement by immunochromatography (see Patent Document 1).
- the test kit is (1) a liquid sample is developed downstream by capillary action, and (2) a substance to be detected in the liquid sample is detected. Whether or not the substance to be detected is contained in the liquid sample is determined by whether or not the test line provided downstream in the liquid development direction is labeled.
- FIG. 9 is a side view of a conventional immunochromatographic test kit.
- the test kit a includes a kit body b for developing a liquid sample to detect a substance to be detected, an absorption pad c for sucking the liquid sample downstream of the kit body b, and a sheet d for installing the kit body b and the absorption pad c.
- the kit body b has a plurality of members, specifically, a sample dropping pad e, a labeling substance holding pad f, and an immobilizing membrane g. These members e to g are connected to each other at least a part of the adjacent members in order to develop the liquid sample.
- each member of the kit body b will be described.
- the sample dropping pad e is a pad for dropping a liquid sample.
- the labeling substance holding pad f is a pad for uniformly holding the labeling substance.
- the labeling substance holding pad f is prepared by impregnating the pad with a solution containing the labeling substance and then drying the pad.
- the labeled substance here refers to the first substance (antibody or antigen) that specifically binds to the substance to be detected (antigen or antibody) in the liquid sample. Or a substance immobilized on a fluorescently labeled ligand.
- the immobilization membrane g is a pad on which a second substance (an antibody or an antigen) that specifically binds to a substance to be detected in a liquid sample is fixed in a line shape.
- the liquid sample When a liquid sample is dropped onto the sample dropping pad e, the liquid sample expands the sample dropping pad e and flows into the labeling substance holding pad f through the joint surface h with the labeling substance holding pad f. Then, the labeling substance uniformly held by the labeling substance holding pad f by the liquid sample flows out and flows into the immobilization membrane g through the joint surface i with the immobilization membrane g together with the liquid sample. Furthermore, the liquid sample spreads on the immobilizing membrane g and is absorbed by the absorption pad c through the joint surface j with the absorption pad c.
- the detected substance when the detected substance is contained in the liquid sample, the detected substance binds to the first substance of the labeling substance. Then, the second substance immobilized in a line on the immobilizing membrane g becomes an immobilized sample, and the substance to be detected, to which the labeled substance is bound, specifically binds and is captured in a line. As a result, the labeled test line can be visually confirmed by capturing the labeled substance in a line, and the detected substance in the sample is detected.
- Test kits using immunochromatography require rapid and highly sensitive detection. Therefore, the labeling substance held on the labeling substance holding pad is expanded to the test line position of the immobilized membrane earlier, and the labeling substance is not left near the test line so that the test line can be easily identified. It is necessary to ensure that it is deployed.
- the conventional test kit a uses the labeling substance holding pad f that uniformly holds the labeling substance. For this reason, there is a possibility that the labeling substance is retained due to the turbulence of the flow of the liquid sample due to the inflow from the joining surface h. Further, the lower surface of the sample dropping pad e was bonded to the upper surface of the labeling substance holding pad f in a relatively wide range. For this reason, the range in which the liquid flows in from the joint surface h is wide, and the liquid sample flows into the labeling substance holding pad f more vigorously than inflowing only by capillary action due to gravity, and the disturbance of the flow of the liquid sample increases. , Retention of the labeled substance occurred.
- the liquid sample containing the staying labeled substance may flow backward against the development direction.
- the retention means that when the flow of the liquid sample from the upstream to the downstream is disturbed, the flow of the labeling substance is stagnated due to the disturbance of the flow.
- an object of the present invention is to provide a test kit capable of rapid and highly sensitive detection.
- a test kit is a kit for developing a liquid sample in a developing direction to detect a substance to be detected contained in the liquid sample, and a labeled substance in which a label is fixed to a substance that specifically binds to the substance to be detected
- a first member including a region where the first member is held and a detection zone for collecting the labeled substance via the substance to be detected, connected to the downstream of the first member in the development direction, and from the first member And a second member for developing the labeling substance contained in the flowing liquid sample in the detection zone.
- the first member is located on the most upstream side, includes a dropping region including a portion where a liquid sample is dropped, a containing portion connected to the second member and containing a labeling substance, and located upstream of the containing portion. It is connected between the labeling substance holding region having an uncontained part not containing the labeling substance and the dropping region and the non-containing part of the labeling substance holding region, and the water absorption power is set higher than that of the dropping region. And a backflow prevention region.
- the first member may be produced by processing a single sheet member.
- the backflow prevention region is formed by compressing the intermediate region in the longitudinal direction of the sheet member.
- the labeling substance holding region is formed by immersing from one end in the longitudinal direction of the sheet member to a position not reaching the backflow prevention region in a solution containing the labeling substance and then drying.
- the first member may be integrally formed by compressing the members in the labeling substance holding region and / or the backflow prevention region.
- the inspection kit includes an inspection kit body having a first member and the second member, and a case for housing the inspection kit body, and the case has an intermediate region in the longitudinal direction of the sheet member at each predetermined pressure.
- a pressing portion for pressing may be formed.
- FIG. 5 is a cross-sectional view taken along the line AA in FIG. 4. It is a side view showing one modification of the 1st pad. It is a side view which shows the other modification of a 1st pad. It is a figure which shows the state which accommodated the test
- FIG. 1 is a plan view showing an example of an inspection kit 1 according to the first embodiment.
- FIG. 2 is a side view of the test kit 1 of FIG.
- FIG. 3A is a side view of the first pad.
- FIG. 3B is a perspective view of the first pad.
- the test kit 1 is a kit for detecting a substance to be detected (antigen or antibody, the same applies hereinafter) contained in a liquid sample by developing the liquid sample in a developing direction (hereinafter, sometimes simply referred to as a developing direction). Specifically, it is determined whether or not the liquid sample contains a substance to be detected based on whether or not the test line provided downstream in the development direction of the liquid sample dropped on the test kit 1 is labeled. The direction of development of the liquid sample is indicated by an arrow in the figure.
- the inspection kit 1 has a kit body 10, an absorption pad 20, and a sheet 30.
- the sheet 30 may be, for example, a well-known sheet that is waterproof and has an adhesive upper surface.
- the kit body 10 and the absorption pad 20 are arranged on the upper surface of the sheet 30, the kit body 10 and the absorption pad 20 are arranged.
- the absorption pad 20 is disposed so as to overlap the downstream end of the kit body 10 and sucks up the liquid sample that develops the kit body 10.
- the kit body 10 develops the liquid sample to determine the presence or absence of the substance to be detected in the liquid sample.
- the kit body 10 includes a multifunctional member 17 as a first member and an immobilizing membrane 15 as a second member.
- the multifunctional member 17 includes a region in which a labeling substance in which a label is fixed to a substance (antibody or antigen, hereinafter the same) that specifically binds to the substance to be detected is held.
- the multifunction member 17 will be described in detail later.
- the fixed membrane 15 is connected downstream of the multifunctional member 17 in the deployment direction. Specifically, the fixed membrane 15 is disposed such that an end portion on the upstream side in the development direction overlaps with an end portion on the downstream side in the development direction of the multifunctional member 17.
- a joining surface d ⁇ b> 1 is formed by the upper surface of the fixed membrane 15 and the lower surface of the multifunctional member 17.
- the immobilizing membrane 15 has a higher water absorption force than any region of the multifunctional member 17 and has a slower liquid development speed.
- the immobilization membrane 15 is formed of a finer fiber member (film body) than the multifunctional member 17 such as a nitrocellulose membrane. Therefore, the liquid sample is absorbed by the immobilizing membrane 15 through the bonding surface d1 with a stronger force (higher water absorption force) than when the multifunctional member 17 is deployed.
- the immobilization membrane 15 has a detection zone 15a that is an area where a substance (an antibody or an antigen, the same applies hereinafter) that specifically binds to a substance to be detected is immobilized (see FIG. 1).
- a labeled binding substance which will be described later, specifically binds to the detection zone 15a, and the test substance is labeled by capturing the labeled substance in a line.
- the immobilization membrane 15 may further have a control zone which is a region where a control substance (antibody or antigen, hereinafter the same) is immobilized.
- the control zone is desirably arranged on the downstream side of the detection zone 15a.
- control labeling substance in which insoluble carrier particles or the like for labeling are immobilized on a substance (antigen or antibody) that specifically binds to the control substance is further retained on the multifunctional member 17, etc. It can be confirmed that the liquid sample (including these labeling substances) has developed in the control zone.
- the absorption pad 20 is a pad that absorbs the liquid sample of the kit body 10. At least a part of the absorbent pad 20 is connected downstream of the immobilizing membrane 15 in the deployment direction. Specifically, the upstream end of the absorbent pad 20 in the deployment direction is placed on the downstream end of the immobilizing membrane 15 in the deployment direction. Thereby, the bonding surface d ⁇ b> 2 is formed by the upper surface of the absorbent pad 20 and the lower surface of the immobilizing membrane 15. The liquid sample is absorbed by the absorption pad 20 through the bonding surface d2.
- the multi-function member 17 is composed of a piece of rectangular sheet-like member (hereinafter sometimes referred to as a sheet member).
- the multifunction member 17 has a plurality of regions.
- the multi-function member 17 includes a sample dropping area 171, a labeling substance holding area 172, and a backflow prevention area 173.
- the sheet member for example, a fiber member having a uniform mesh is used, and the multifunctional member 17 is manufactured by processing the fiber member.
- the sample dripping region 171 is located at the uppermost stream in the developing direction of the multifunctional member 17 and has a dripping portion where a liquid sample is dripped (not shown).
- the sample dropping region 171 has a predetermined water absorption force.
- the sample dripping region 171 is a region with a relatively coarse fiber, in which the water absorption force is relatively low and the development speed is set high.
- the labeling substance holding region 172 is a region that is located on the most downstream side in the developing direction of the multifunctional member 17 and is connected to the immobilizing membrane 15. Specifically, in the illustrated example, at the bonding surface d1, it is arranged so that only the containing portion 172b is in contact with the upper surface of the immobilizing membrane 15.
- the labeling substance holding region 172 may have the same water absorption force as the sample dropping region 171.
- the labeling substance holding region 172 is a region with relatively coarse fibers, which is set to have a relatively low water absorption and a high deployment speed.
- the labeling substance holding area 172 is an area where the labeling substance is held.
- the labeling substance holding region 172 includes a containing part 172b that uniformly contains a labeling substance and an uncontaining part 172a that does not contain a labeling substance.
- the non-containing part 172a is located on the upstream side in the developing direction of the containing part 172b.
- the labeling substance is a substance (antibody or antibody, hereinafter the same) that specifically binds to the substance to be detected in the liquid sample is immobilized on an insoluble carrier particle, enzyme-labeled ligand, or fluorescently-labeled ligand as a label. It is a material that has been turned into a material. Examples of the insoluble simple particles serving as a label include gold colloid, platinum colloid, colored particles, and fluorescent particles.
- the labeling substance holding region 172 in the multifunctional member 17 is labeled from one end in the longitudinal direction of the sheet member (the end downstream in the developing direction as the multifunctional member 17) to a position where it does not reach the backflow prevention region 173. After impregnating the solution containing the chemical substance, it is formed by drying. Thereby, in the labeling substance holding region 172, the containing part 172b and the non-containing part 172a are formed. By forming in this way, the multifunctional member 17 can be manufactured easily. Note that the production of the labeling substance holding region 172 is not limited to the above method. Further, the labeling substance of the containing portion 172b may not be uniform and may be partially retained.
- the backflow prevention region 173 is a region connected between the sample dropping region 171 and the labeling substance holding region 172.
- An interface b1 is formed between the sample dropping region 171 and the backflow prevention region 173, and an interface b2 is formed between the backflow prevention region 173 and the labeling substance holding region 172.
- the backflow prevention region 173 has higher water absorption than the adjacent sample dripping region 171 and the labeled substance holding region 172, and the liquid development speed is slower.
- the backflow prevention region 173 is a finer region of fibers than the sample dripping region 171 and the labeling substance holding region 172.
- the liquid sample flows into the backflow prevention region 173 through the interface b1 with a stronger force (water absorption force) than the sample dropping region 171 and expands the backflow prevention region 173 through the interface b2. It flows into the labeled substance holding region 172 with a weak force (water absorption force).
- the backflow prevention region 173 is formed by compressing the intermediate region in the longitudinal direction of the sheet member. Therefore, the function of preventing the backflow can be easily realized by compressing a part of the sheet member.
- the multi-function member 17 is formed of a single rectangular sheet-like member, and compresses only the backflow prevention region 173, thereby making a difference in the water absorption force between the backflow prevention region 173 and the other regions 171 and 172. I was wearing it. For this reason, the sample dripping area
- the water absorption force of the labeling substance holding region 172 may be set higher than the water absorption force of the sample dropping region 171 or may be set lower. In this case, you may make it compress any area
- the present invention is not limited to this.
- the containing portion 172b but also the non-containing portion 172a may be disposed on the upper surface of the immobilizing membrane 15.
- the upper surface of the immobilizing membrane 15 may be disposed so that a part of the lower surface of the containing portion 172b is in contact therewith. In any case, it is desirable that only the labeling substance holding region 172 is in contact with the immobilized membrane 15.
- the end portions of the multifunctional member 17 and the absorbent pad 20 that are not in contact with other members are arranged away from the sheet 30, but these end portions are bonded to the sheet 30. May be.
- the inspection kit 1 may be covered with a cover (not shown) made of a waterproof material.
- the cover may be transparent so that the test line can be visually recognized, and an opening through which the liquid sample passes may be formed in the dropping portion.
- FIG. 4 is a plan view showing an example of the case 50.
- FIG. 5 is a cross-sectional view taken along the line AA in FIG.
- the case 50 includes a case main body 52 that houses the inspection kit 1 and a lid 51 that covers the case main body 52.
- the case body 52 is provided with a plurality of protrusions 521 for positioning the inspection kit 1.
- the lid 51 is formed with an opening 511 for dropping a liquid sample into the sample dropping region 171 and an opening 512 for visually recognizing a test line on the immobilizing membrane 15.
- the inspection kit 1 covered with the cover may be accommodated in the case 50, or the inspection kit 1 may be accommodated in the case 50 as it is.
- the lid 51 and the case 52 may be provided with a stopper for closing the lid 51.
- the immobilizing membrane 15 of the kit main body 10 is set to have a higher water absorption force than any region of the multifunctional member 17.
- the water absorption force of the backflow prevention region 173 is set higher than the water absorption force of the labeling substance holding region 172 and the sample dropping region 171.
- the liquid sample is absorbed by the labeling substance holding region 172 through the interface b2 with a weaker force (lower water absorption force) than when the backflow prevention region 173 is developed. At this time, the liquid sample flows only into the non-containing portion 172a from the interface b2. The liquid sample flows out the labeling substance held in the containing portion 172b while gently flowing from the non-containing portion 172a toward the containing portion 172b.
- the labeling substance that has flowed out is absorbed by the immobilizing membrane 15 together with the liquid sample with a stronger force (high water absorption force) than when the labeling substance holding region 172 is developed through the joint surface d1.
- the liquid sample remaining in the non-containing part 172a flows out the labeling substance even after the labeling substance is almost discharged from the containing part 172b.
- a labeled binding substance in which the labeling substance is specifically bound to the substance to be detected is generated during the development.
- the labeled binding substance binds to the immobilized sample in the detection zone 15a and is labeled as a test line.
- the liquid sample in which the immobilized membrane 15 is developed reaches the bonding surface d2, it is absorbed by the absorption pad 20.
- the liquid sample flows into the containing portion 172b from the non-containing portion 172a having a uniform fiber mesh. Therefore, the disturbance of the liquid sample in the containing portion 172b is suppressed, and the retention of the labeling substance caught in the liquid sample can be suppressed. In addition, as long as the disturbance of the liquid sample flowing into the containing portion 172a can be suppressed, the fiber mesh of the labeling substance holding region 172 may not be uniform.
- the test kit 1 connects the end surface of the non-containing portion 172a and the end surface of the backflow prevention region 173 next to each other, so that the upstream region is superimposed on the non-containing portion 172a.
- the area of the interface b2 can be reduced, and the liquid sample can flow in without being affected by gravity. Thereby, disturbance of the flow of the liquid sample can be suppressed and the retention of the labeled substance can be further suppressed.
- the liquid sample can cause the labeled substance to flow through the immobilization membrane 15 more quickly, and the remaining liquid sample can promote the flow of the labeled substance, so that rapid and sensitive detection can be performed. it can.
- the assembly can be simplified by integrally forming the multifunctional member 17 of the inspection kit 1.
- the multi-function member 17 is integrally formed as a single member, but is not limited thereto.
- the multifunctional member 17 may use different members (for example, fibrous members having different eye roughness) for each region, and join them to form a single member.
- a plurality of members may be connected and arranged on the kit body 10 without using a single member. In this case, the arrangement of the members constituting each region of the multifunctional member 17 is not limited to that shown in FIG.
- a backflow prevention region 173A may be disposed under the sample dropping region 171A, and a labeling substance holding region 172A may be disposed under the backflow prevention region 173A.
- the lower surface of the backflow prevention region 173A is preferably in contact with only the upper surface of the non-containing portion 172Aa of the labeling substance holding region 172A.
- the lower surface of the backflow prevention region 173A may be in any extent as long as it is in contact with the upper surface of the non-containing portion 172Aa.
- the backflow prevention region 173B is disposed adjacent to the downstream of the sample dropping region 171B, and the labeling substance holding region 172B is disposed below the backflow prevention region 173B. May be. ⁇ Second Embodiment >>
- FIG. 8 is a side sectional view showing a state in which the test kit according to the second embodiment is housed in the case.
- a sheet member 27 as a fiber material having a uniform eye roughness that is, water absorption
- region is formed by pressing the intermediate area of the longitudinal direction of the sheet
- the sheet member 27 has a containing region 27B that uniformly contains a labeling substance.
- the containing region 27B is formed by impregnating one end of the sheet member 27 in the longitudinal direction with a solution containing a labeling substance and then drying. Note that the labeling substance is not held in the region 27A other than the containing region 27B of the sheet member 27.
- the case 60 includes a case main body 62 that houses the inspection kit 1 and a lid body 61 that covers the case main body 62.
- a plurality of projecting portions 621 for positioning the inspection kit 1 are erected on the case main body 62.
- the lid 61 is formed with an opening 611 for dropping a liquid material into the sample dropping region 171 and an opening 612 for visually recognizing a test line on the immobilizing membrane 15.
- the lid 61 is formed with a pressing portion 613 for forming a backflow prevention region in the sheet member 27.
- the fibers in the intermediate region in the longitudinal direction of the sheet member 27 are crushed by the pressing portion 613, and more than other regions located upstream and downstream of the sheet member 27. Increases water absorption.
- a backflow prevention region is formed in the intermediate region of the sheet member 27, and a sample dripping region and a labeling substance holding member each having a lower water absorption than the backflow prevention region are respectively provided on the upstream side and the downstream side of the backflow prevention region. A region will be formed.
- the lid 61 has a protrusion 614 for pressing the downstream side of the fixed membrane 15 (for example, the downstream side of the test line position and in the vicinity of the bonding surface d2 between the absorbent pad 20 and the fixed membrane 15). May be provided. As a result, the fibers on the downstream side of the immobilized membrane 15 are crushed, and the flow of the liquid sample can be made smooth.
- the lid 61 of the case 60 is formed with only the pressing portion 613 for forming the backflow prevention region in the intermediate region of the sheet member 27, but is not limited thereto.
- the lid 61 may be formed with a pressing portion for forming the labeling substance holding region in addition to the pressing portion 613 (not shown, hereinafter, this pressing portion is referred to as a second pressing portion).
- the second pressing portion is disposed adjacent to the downstream side of the pressing portion 613 and is formed to press a predetermined range of the downstream end portion of the sheet member 27 including the containing portion 27B. Further, the second pressing part is formed thinner in the vertical direction than the pressing part 613.
- the area pressed by the pressing part 613 is more pressurized than the area pressed by the second pressing part, and the eyes of the fibers are crushed and the water absorption is increased.
- the fiber eyes are not collapsed, so the water absorption is set lower than the area where the fiber eyes are closed.
- a sample dropping region where no pressure is applied is formed on the upstream side of the sheet member 27, and is pressed by the second pressing portion on the downstream side of the sheet member 27.
- the labeled substance holding area formed is formed, and the backflow prevention area pressed by the pressure higher than the second pressing part (by the pressing part 613) is formed between the sample dropping area and the labeling substance holding area.
- the press part 613 (same also about a 2nd press part) was formed in the cover body 61 of case 60, it is not restricted to this.
- these pressing portions may be formed to protrude from the bottom portion of the case main body 62.
- a restraining member that restrains the intermediate region of the sheet member 27 from above and below with a predetermined pressing force without using the case 60 may be used.
- Inspection kit 10. Kit body 17. Multifunctional member 15. Immobilized membrane 20. Absorption pad 30. Sheet 171. Sample dropping area 172. Labeled substance holding region 172a. Uncontaining part 172b. Contained portion 173. Backflow prevention area
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Abstract
Description
<<第一実施形態>>
検査キット1は、液体試料を展開方向(以下、単に展開方向という場合がある)に展開させて、液体試料に含まれる被検出物質(抗原又は抗体、以下同じ)を検出するキットである。具体的には、検査キット1に滴下された液体試料の展開方向下流に設けられたテストラインが標識されるか否かにより、液体試料に被検出物質が含まれるか否かが判定される。液体試料の展開方向を矢印で図に示す。
キット本体10は、第1の部材としての多機能部材17と、第2の部材としての固定化メンブレン15とを有する。多機能部材17は、被検出物質に特異に結合する物質(抗体又は抗原、以下同じ)に標識を固定した標識化物質が保持される領域を含む。多機能部材17については、後に詳述する。
以下、液体試料の滴下による検査キット1内部の振る舞いを簡単に説明する。
(*)液体試料は、試料滴下領域171を展開し、界面b1を介して、試料滴下領域171を展開するよりも高い吸水力で逆流防止領域173に吸収される。
(*)逆流防止領域173に流入した液体試料は、力強く(高い吸水力で)ゆっくり下流に展開する。
(*)液体試料は、界面b2を介して、逆流防止領域173を展開するよりも弱い力(低い吸水力)で標識化物質保持領域172に吸収される。
このとき、液体試料は、界面b2より未含有部分172aのみに流入する。そして、液体試料は、未含有部分172aから含有部分172b向かってに静かに流れながら、含有部分172bに保持された標識化物質を流し出す。
(*)流し出された標識化物質は、接合面d1を介して、標識化物質保持領域172を展開するよりも強い力(高い吸水力)で液体試料とともに固定化メンブレン15に吸収される。
このとき、含有部分172bからおおよそ標識化物質が流し出された後も、未含有部分172aに残る液体試料が標識化物質を流し出す。
(*)液体試料に被検出物質が含まれる場合には、展開中に、被検出物質に標識化物質が特異的に結合した標識化結合物質が生成される。そして、検出ゾーン15aの固定化試料に標識化結合物質が結合し、テストラインとして標識される。
(*)固定化メンブレン15を展開した液体試料は、接合面d2に到達すると、吸収パッド20に吸収される。
<<第二実施形態>>
Claims (5)
- 液体試料を展開方向に展開させて、前記液体試料に含まれる被検出物質を検出する検査キットであって、
前記被検出物質に特異に結合する物質に標識を固定した標識化物質が保持される領域を含む第1の部材と、
前記被検出物質を介して前記標識化物質を捕集する検出ゾーンを有し、前記第1の部材の展開方向下流に接続されて、前記第1の部材から流入する前記液体試料に含まれる前記標識化物質を前記検出ゾーンに展開する第2の部材と
を備え、
前記第1の部材は、
最上流に位置して、前記液体試料が滴下される部分を含む滴下領域と、
前記第2の部材に接続され、前記標識化物質を含有する含有部分と、前記含有部分の上流に位置する前記標識化物質を含有しない未含有部分とを有する標識化物質保持領域と、
前記滴下領域と前記標識化物質保持領域の未含有部分との間に接続されて、前記滴下領域よりも吸水力が高く設定される逆流防止領域と
を有する検査キット。 - 前記第一の部材は、一片のシート部材を加工することで作製される
請求項1に記載の検査キット。 - 前記逆流防止領域は、前記シート部材の長手方向の中間領域を圧縮することにより形成される
請求項2に記載の検査キット。 - 前記検査キットは、前記第1の部材及び前記第2の部材を有する検査キット本体と、
前記検査キット本体を収容するケースと、を備え、
前記ケースには、前記シート部材の長手方向の中間領域を所定の各圧力で押圧する押圧部が形成される
請求項3に記載の検査キット。 - 前記標識化物質保持領域は、前記シート部材の長手方向の一方の端部から、前記逆流防止領域に達しない位置までを、前記標識化物質を含有する溶液に浸した後に乾燥することにより形成される
請求項2に記載の検査キット。
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EP (1) | EP2975408B1 (ja) |
JP (1) | JP6105335B2 (ja) |
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US10295533B2 (en) | 2013-03-13 | 2019-05-21 | Denka Seiken Co., Ltd. | Test kit |
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JP6254994B2 (ja) * | 2014-11-18 | 2017-12-27 | 株式会社ニチレイバイオサイエンス | 検査キット |
KR101981858B1 (ko) | 2016-12-02 | 2019-05-24 | 장휴정 | 안구 질병검사 키트 |
JP6916103B2 (ja) * | 2017-12-15 | 2021-08-11 | 積水メディカル株式会社 | イムノクロマト検査用デバイス |
FR3100890B1 (fr) * | 2019-09-17 | 2024-02-16 | Innopsys | Méthode et lecteur portable d’analyse d’échantillon de liquide biologique |
KR102597405B1 (ko) * | 2020-12-04 | 2023-11-07 | (주)오상헬스케어 | 현장진단형 핵산추출장치 |
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Also Published As
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JP2014178153A (ja) | 2014-09-25 |
KR102182596B1 (ko) | 2020-11-24 |
US20160033501A1 (en) | 2016-02-04 |
EP2975408B1 (en) | 2018-10-03 |
KR20150126866A (ko) | 2015-11-13 |
EP2975408A1 (en) | 2016-01-20 |
ES2702296T3 (es) | 2019-02-28 |
JP6105335B2 (ja) | 2017-03-29 |
US10295533B2 (en) | 2019-05-21 |
EP2975408A4 (en) | 2016-11-02 |
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