TW201927249A - Testing kit - Google Patents
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- TW201927249A TW201927249A TW107104084A TW107104084A TW201927249A TW 201927249 A TW201927249 A TW 201927249A TW 107104084 A TW107104084 A TW 107104084A TW 107104084 A TW107104084 A TW 107104084A TW 201927249 A TW201927249 A TW 201927249A
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- 239000000126 substance Substances 0.000 claims abstract description 255
- 239000007788 liquid Substances 0.000 claims abstract description 121
- 239000012528 membrane Substances 0.000 claims abstract description 93
- 238000003825 pressing Methods 0.000 claims abstract description 45
- 238000007689 inspection Methods 0.000 claims description 59
- 238000001514 detection method Methods 0.000 claims description 42
- 238000000034 method Methods 0.000 claims description 7
- 238000002372 labelling Methods 0.000 abstract description 17
- 238000010521 absorption reaction Methods 0.000 description 23
- 239000000427 antigen Substances 0.000 description 16
- 102000036639 antigens Human genes 0.000 description 16
- 108091007433 antigens Proteins 0.000 description 16
- 239000000463 material Substances 0.000 description 8
- 239000002245 particle Substances 0.000 description 6
- NIHNNTQXNPWCJQ-UHFFFAOYSA-N fluorene Chemical compound C1=CC=C2CC3=CC=CC=C3C2=C1 NIHNNTQXNPWCJQ-UHFFFAOYSA-N 0.000 description 4
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- 239000002994 raw material Substances 0.000 description 3
- 239000013558 reference substance Substances 0.000 description 3
- 238000011144 upstream manufacturing Methods 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
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- 239000003446 ligand Substances 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 229920001778 nylon Polymers 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 229920000570 polyether Polymers 0.000 description 2
- 229920000098 polyolefin Polymers 0.000 description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 description 2
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- 241000894006 Bacteria Species 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 239000000020 Nitrocellulose Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 230000002745 absorbent Effects 0.000 description 1
- 239000002250 absorbent Substances 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
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- 239000000084 colloidal system Substances 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
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- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 230000003100 immobilizing effect Effects 0.000 description 1
- 238000003317 immunochromatography Methods 0.000 description 1
- 238000005470 impregnation Methods 0.000 description 1
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- 239000011148 porous material Substances 0.000 description 1
- 210000003296 saliva Anatomy 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 241000712461 unidentified influenza virus Species 0.000 description 1
- 238000011179 visual inspection Methods 0.000 description 1
- 239000002982 water resistant material Substances 0.000 description 1
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
- G01N33/543—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
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- 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
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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
-
- 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
-
- 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
- G01N33/54306—Solid-phase reaction mechanisms
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Immunology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Analytical Chemistry (AREA)
- Physics & Mathematics (AREA)
- Cell Biology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Biochemistry (AREA)
- Pathology (AREA)
- General Physics & Mathematics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Clinical Laboratory Science (AREA)
- Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Sampling And Sample Adjustment (AREA)
Abstract
Description
本發明涉及一種檢查套組。 The invention relates to an inspection kit.
作為採取唾液等檢體而判定該檢體中是否含有細菌或病毒等被測定物質之器件,例如公開有免疫色譜法用器件(例如參照專利文獻1)。 As a device for taking a specimen such as saliva and determining whether the specimen contains a substance to be measured such as bacteria or virus, a device for immunochromatography is disclosed (for example, refer to Patent Document 1).
上述器件是將包括樣本添加部件、標記保持部件、色譜用膜載體等之試紙條夾入盒體中,將滴加至上述樣本添加部件之樣本供給至標記保持部件而使成為標記之經著色之粒子(標記物質)結合於被測定物質後,使固定在色譜用膜載體上之抗體捕捉並蓄積該結合物,由此藉由目測來判定有無上述被測定物質。 In the device described above, a test strip including a sample adding member, a label holding member, a membrane carrier for chromatography, and the like is sandwiched in a box body, and a sample added dropwise to the sample adding member is supplied to the label holding member so that the colored label becomes colored. After the particles (labeled substances) are bound to the substance to be measured, the antibody immobilized on the chromatographic membrane carrier captures and accumulates the conjugate, and the presence or absence of the substance to be measured is determined by visual inspection.
這種器件中,在夾住試紙條之一對盒體之相對向之部位設置有凸部,利用該凸部使樣本添加部件與標記保持部件緊貼,由此,能夠將滴加至上述樣本添加部件之樣本有效率地供給至標記保持部件,從而使標記物質確實地結合於被測定物質。 In this device, a convex portion is provided at a portion of the test strip that is opposite to the case, and the sample adding member and the mark holding member are brought into close contact with each other by the convex portion. The sample of the sample adding member is efficiently supplied to the label holding member, so that the labeling substance is reliably bound to the substance to be measured.
[先前技術文獻] [Prior technical literature]
[專利文獻] [Patent Literature]
[專利文獻1]日本專利特開2005-37384號公報 [Patent Document 1] Japanese Patent Laid-Open No. 2005-37384
然而,如上述之以往之器件中,保持於標記保持部件中之標記物質有時會在色譜用膜載體中一下子大量展開。因此,在發生上述大量展開之情況下,有將該大量標記物質之著色誤認為被色譜用膜載體上之抗體捕捉到之結果之傾向,從而有儘管不存在被測定物質,但導致彷彿存在被測定物質似之誤判定之擔憂。 However, in the conventional devices described above, the labeling substance held in the label holding member may be unfolded in a large amount in the membrane carrier for chromatography at one time. Therefore, in the case of the above-mentioned large-scale development, there is a tendency that the coloring of this large amount of labeling substance is mistaken for the result of being captured by the antibody on the membrane carrier for chromatography, so that although the substance to be measured does not exist, it may result in the existence of Concerns about erroneous determination of measured substances.
本發明係基於如上情況而完成者,其目的在於提供一種能夠確實地判定有無被檢測物質(被測定物質)之檢查套組。 The present invention has been completed based on the above-mentioned circumstances, and an object thereof is to provide an inspection kit capable of accurately determining the presence or absence of a substance to be detected (a substance to be measured).
本發明涉及:(1)一種檢查套組,具備試紙條,該試紙條是樣本滴加墊、標記化物質保持墊以及固定化膜片按照該順序連接,前述樣本滴加墊供滴加包含被檢測物質之液體樣本,前述標記化物質保持墊含浸有選擇性地結合於前述被檢測物質且成為標記之標記化物質,前述固定化膜片具有將結合有前述標記化物質之被檢測物質固定之固定化物質,且在所滴加之前述液體樣本朝向前述固定化膜片依序展開之同時,在該固定化膜片檢測前述被檢測物質;且前述檢查套組之特徵在於:前述試紙條具有至少標記化物質保持墊之一部分與固定化膜片之一部分相互重合之部位,前述檢查套組具備按壓部,該按壓部對前述重合部位中之與前述液體樣本展開方向正交之方向上之一部分進行按壓, 在前述固定化膜片中之前述液體樣本展開之流域、同時也是被前述按壓部按壓之部位正下方之前述液體樣本展開之流域以外之流域,能夠從外部確認前述被檢測物質之檢測;(2)根據前述(1)所記載之檢查套組,其中按壓部是以對重合部位中之與液體樣本展開方向正交之方向上之兩端部進行按壓之方式配設;(3)根據前述(1)或(2)所記載之檢查套組,其中標記化物質保持墊具有包含標記化物質之含有部分以及與該含有部分鄰接且不包含前述標記化物質之未含有部分,樣本滴加墊與前述未含有部分連接,前述含有部分之至少一部分與固定化膜片連接;(4)根據前述(1)或(2)所記載之檢查套組,其中重合部位係至少樣本滴加墊之一部分、標記化物質保持墊之一部分以及固定化膜片之一部分按照該順序積層之構造;(5)一種檢查套組,具備:第1盒體;以及第2盒體,以介隔試紙條與前述第1盒體對向之方式配置而夾持前述試紙條;且按壓部是以對重合部位中之與液體樣本展開方向正交之方向上之一部分進行按壓之方式設置於前述第1及/或第2盒體;(6)根據前述(5)所記載之檢查套組,其具備用以從外部確認被檢測物質之檢測之窗部,且前述窗部配置於第1及/或第2盒體之面對固定化膜片之部位、同時也是面對從被按壓部按壓之部位流出之液體樣本展開之正下方之流域以外之流域之部位;以及 (7)一種方法使用檢查套組之被檢測物質之檢測方法,該檢查套組具備試紙條,該試紙條是樣本滴加墊、標記化物質保持墊以及固定化膜片按照該順序連接,前述樣本滴加墊供滴加包含被檢測物質之液體樣本,前述標記化物質保持墊含浸有選擇性地結合於前述被檢測物質且成為標記之標記化物質,前述固定化膜片具有將結合有前述標記化物質之被檢測物質固定之固定化物質,且在所滴加之前述液體樣本朝向前述固定化膜片依序展開之同時,在該固定化膜片檢測前述被檢測物質;且前述方法之特徵在於:前述試紙條具有至少前述標記化物質保持墊之一部分與前述固定化膜片之一部分相互重合之部位,前述檢查套組具備按壓部,該按壓部對前述重合部位中之與前述液體樣本展開方向正交之方向上之一部分進行按壓,在前述固定化膜片中之前述液體樣本展開之流域、同時也是被前述按壓部按壓之部位正下方之前述液體樣本展開之流域以外之流域,能夠從外部確認前述被檢測物質之檢測。 The present invention relates to: (1) an inspection kit including a test strip, which is a sample drip pad, a labeled substance holding pad, and an immobilized membrane connected in this order; the sample drip pad is provided for drip application; A liquid sample containing a test substance, the labeled substance holding pad is impregnated with the labeled substance that selectively binds to the test substance and becomes a labeled substance, and the immobilized membrane has a test substance to which the labeled substance is bound A fixed immobilized substance, and while the dropped liquid sample is sequentially deployed toward the immobilized membrane, the detected substance is detected on the immobilized membrane; and the inspection kit is characterized in that the test paper The strip has a portion where at least a portion of the labeled substance holding pad and a portion of the immobilized membrane overlap with each other, and the inspection kit includes a pressing portion which faces a direction orthogonal to the unfolding direction of the liquid sample in the overlapping portion. Press on one part, It is possible to externally confirm the detection of the substance to be detected in the watershed in which the liquid sample is unfolded in the immobilized membrane, and the watershed in which the liquid sample is unfolded directly below the portion pressed by the pressing portion; (2 ) The inspection kit according to the above (1), wherein the pressing portion is provided by pressing both end portions in a direction orthogonal to the unfolding direction of the liquid sample in the overlapping portion; (3) According to the above ( The inspection kit according to 1) or (2), wherein the labeled substance holding pad has a contained portion containing the labeled substance and an uncontaining portion adjacent to the contained portion and does not include the labeled substance, and the sample dropping pad is provided with The non-containing portion is connected, and at least a portion of the containing portion is connected to the fixed membrane; (4) The inspection kit according to (1) or (2) above, wherein the overlapping portion is at least a part of the sample drip pad, A structure in which a part of the labeled substance holding pad and a part of the immobilized membrane are laminated in this order; (5) An inspection kit including: a first case; and a second case, The test strip is arranged to face the first case to hold the test strip; and the pressing portion is provided to press a part of the overlapping portion in a direction orthogonal to the direction in which the liquid sample is unfolded. In the first and / or second case; (6) The inspection kit according to (5), which includes a window portion for externally confirming the detection of the detected substance, and the window portion is disposed in the first The part of the first and / or second case that faces the immobilized diaphragm and also faces the part of the watershed other than the area immediately below the unfolded liquid sample flowing from the part pressed by the pressing part; and (7) A method for detecting a substance to be detected using an inspection kit, the inspection kit is provided with a test strip, and the test strip is a sample dropping pad, a labeled substance holding pad, and an immobilized membrane connected in this order The aforementioned sample dropping pad is used for dropping a liquid sample containing a substance to be detected, the labeled substance holding pad is impregnated with the labeled substance which selectively binds to the detected substance and becomes a label, and the immobilized membrane has a An immobilized substance having the aforementioned labeled substance and an immobilized substance to be detected, and the aforementioned liquid sample is sequentially developed toward the immobilized membrane, and the aforementioned substance is detected on the immobilized membrane; and the aforementioned method It is characterized in that the test strip has a portion where at least a portion of the labeled substance holding pad and a portion of the fixed membrane overlap each other, and the inspection kit is provided with a pressing portion which presses the pressing portion against the overlapping portion. Press the liquid sample in a direction orthogonal to the unfolding direction of the liquid sample, and spread the liquid sample in the fixed film. The basin, the basin is also outside of the bottom of the liquid sample positive deployment Basin of the pressing portion of the pressing portion, it was confirmed that the substances to be detected by the detector from the outside.
此外,在本說明書中,所謂「試紙條」,是指包括樣本滴加墊、標記化物質保持墊、固定化膜片等,且供液體樣本正常時流通之一連串部件。又,所謂「被按壓部按壓之部位正下方之液體樣本展開之流域以外之流域」,是指例如圖3所示般在箭頭表示之液體樣本等展開方向上被凸部911(按壓部910)按壓之部位及位於該部位之正下方(下游)之固定化膜片51內之俯視下之區域R(網狀陰影部)以外之固定化膜片51內之區域P。此外,圖3中,根據各自之位置關係,L1表示區域R之寬度,L2表示區域P之寬度,L3表示窗部915之寬度。又,所謂「窗部」,係指包括 物理性地開口之貫通孔以及能夠經由特定之部件從外部觀察或偵測有無被檢測物質之部位這兩者之概念。 In addition, in the present specification, the "test strip" refers to a series of parts including a sample drip pad, a labeled substance holding pad, an immobilized membrane, and the like, and a liquid sample is circulated when the liquid sample is normal. In addition, the "watershed other than the area where the liquid sample is directly under the part pressed by the pressing part" means a convex part 911 (pressing part 910) in the unfolding direction such as the liquid sample indicated by the arrow as shown in Fig. 3 The area P inside the fixed film 51 other than the pressed portion and the area R (the mesh shaded portion) in the plan view inside the fixed film 51 located immediately below (downstream) the area. In addition, in FIG. 3, according to the respective positional relationships, L1 represents the width of the region R, L2 represents the width of the region P, and L3 represents the width of the window portion 915. The term "window" refers to The concept of a physically open through-hole and a part that can observe or detect the presence or absence of a substance to be detected from the outside through a specific component.
又,本說明書中之「樣本滴加墊」及「標記化物質保持墊」終歸係功能性區別,未必每項功能都要由單獨之部件構成。例如,本說明書中之「樣本滴加墊」及「標記化物質保持墊」係包括一體化部件之概念,該一體化部件具有供滴加包含被檢測物質之液體樣本之區域以及含浸有選擇性地結合於被檢測物質且成為標記之標記化物質之區域。 In addition, the “sample dropping pad” and the “marked substance holding pad” in this specification are functional differences, and each function may not necessarily be constituted by a separate component. For example, the "sample dropping pad" and "labeled substance holding pad" in this specification are concepts including an integrated component that has a region for dripping a liquid sample containing a substance to be detected and a selective impregnation. Ground binds to the area of the substance to be detected and becomes a labeled, labeled substance.
又,在本說明書中,所謂「至少標記化物質保持墊之一部分與固定化膜片之一部分相互重合」,係這樣一種概念,即,不限定於標記化物質保持墊與固定化膜片直接重合之態樣,而是包括標記化物質保持墊與固定化膜片介隔不同於此等部件之其他部件而重合之態樣。 In the present specification, the term "at least a part of the labeled substance holding pad and a part of the immobilized membrane overlap" is a concept that is not limited to the case where the labeled substance holding pad and the immobilized membrane are directly overlapped. This aspect includes the aspect in which the labeled substance holding pad and the immobilized membrane are overlapped with each other through other components different from these components.
本發明可提供一種能夠確實地判定有無被檢測物質之檢查套組。 The present invention can provide an inspection kit capable of accurately determining the presence or absence of a substance to be detected.
g‧‧‧間隙 g‧‧‧ clearance
11、12、13‧‧‧檢查套組 11, 12, 13‧‧‧ Inspection Kit
21、22、23‧‧‧試紙條 21, 22, 23‧‧‧ test strips
31‧‧‧樣本滴加墊 31‧‧‧Sample drop pad
41、42、43‧‧‧標記化物質保持墊 41, 42, 43‧‧‧‧ Marked substance holding pads
42a‧‧‧含有部分 42a‧‧‧ contains part
42b‧‧‧未含有部分 42b‧‧‧ does not contain part
51‧‧‧固定化膜片 51‧‧‧Fixed diaphragm
61‧‧‧吸收墊 61‧‧‧ Absorbent pad
71‧‧‧襯板 71‧‧‧ liner
81、83‧‧‧第1盒體 81, 83‧‧‧ first box
91、93‧‧‧第2盒體 91, 93‧‧‧ Box 2
910、920、930‧‧‧按壓部 910, 920, 930‧‧‧Pressing section
915‧‧‧窗部 915‧‧‧Window
圖1係表示本發明之第1實施形態之概略縱剖面圖。 Fig. 1 is a schematic longitudinal sectional view showing a first embodiment of the present invention.
圖2係圖1之概略俯視圖。 FIG. 2 is a schematic plan view of FIG. 1.
圖3係用以說明本發明之窗部之部位之局部放大概略俯視圖。 Fig. 3 is a partially enlarged schematic plan view for explaining a part of a window portion of the present invention.
圖4係表示圖2之變形例之概略俯視圖。 FIG. 4 is a schematic plan view showing a modification of FIG. 2.
圖5係表示本發明之第2實施形態之概略縱剖面圖。 Fig. 5 is a schematic longitudinal sectional view showing a second embodiment of the present invention.
圖6係圖5之概略俯視圖。 FIG. 6 is a schematic plan view of FIG. 5.
圖7係表示本發明之第3實施形態之概略縱剖面圖。 Fig. 7 is a schematic longitudinal sectional view showing a third embodiment of the present invention.
圖8係圖7之概略俯視圖。 FIG. 8 is a schematic plan view of FIG. 7.
<檢查套組> <Check kit>
本發明之檢查套組具備試紙條,該試紙條是樣本滴加墊、標記化物質保持墊以及固定化膜片按照該順序連接,上述樣本滴加墊供滴加包含被檢測物質之液體樣本,上述標記化物質保持墊含浸有選擇性地結合於上述被檢測物質且成為標記之標記化物質,上述固定化膜片具有將結合有上述標記化物質之被檢測物質固定之固定化物質,且在所滴加之上述液體樣本朝向上述固定化膜片依序展開之同時,在該固定化膜片檢測上述被檢測物質;且上述檢查套組之特徵在於:上述試紙條具有至少標記化物質保持墊之一部分與固定化膜片之一部分相互重合之部位,上述檢查套組具備按壓部,該按壓部對上述重合部位中之與上述液體樣本展開方向正交之方向上之一部分進行按壓,在上述固定化膜片中之上述液體樣本展開之流域、同時也是被上述按壓部按壓之部位正下方之上述液體樣本展開之流域以外之流域,能夠從外部確認上述被檢測物質之檢測。 The inspection kit of the present invention is provided with a test strip, which is a sample drip pad, a labeled substance holding pad, and an immobilized membrane connected in this order. The sample drip pad is used to drip the liquid containing the test substance. In the sample, the labeled substance holding pad is impregnated with a labeled substance that selectively binds to the test substance and becomes a label, and the immobilized membrane has an immobilized substance that fixes the test substance to which the labeled substance is bound, And while the dropped liquid sample is sequentially developed toward the fixed membrane, the detected substance is detected on the fixed membrane; and the inspection kit is characterized in that the test strip has at least a labeled substance A portion where a portion of the holding pad and a portion of the fixed membrane overlap each other, the inspection kit includes a pressing portion that presses a portion of the overlapping portion in a direction orthogonal to the direction in which the liquid sample is unfolded. The area where the liquid sample in the immobilized membrane is unfolded is also directly under the part pressed by the pressing part The deployment Basin other than the basin above the liquid sample, it was confirmed that the test substance to be detected from the outside.
以下,雖參照圖式對該檢查套組之第1~第3實施形態進行說明,但本發明並非僅限定於該圖式所記載之實施形態。 Hereinafter, the first to third embodiments of the inspection kit will be described with reference to the drawings, but the present invention is not limited to only the embodiments described in the drawings.
[第1實施形態] [First Embodiment]
圖1係表示本發明之第1實施形態之概略縱剖面圖。又,圖2係圖1之概略俯視圖。如圖1及圖2所示,該檢查套組11概略性地包括:具有樣本滴加墊31、標記化物質保持墊41、固定化膜片51及吸收墊61之試紙條 21、襯板71、第1盒體81、以及第2盒體91。 Fig. 1 is a schematic longitudinal sectional view showing a first embodiment of the present invention. FIG. 2 is a schematic plan view of FIG. 1. As shown in FIG. 1 and FIG. 2, the inspection set 11 roughly includes a test strip with a sample dropping pad 31, a labeled substance holding pad 41, an immobilized membrane 51 and an absorption pad 61. 21. Liner 71, first case 81, and second case 91.
試紙條21係樣本滴加墊31、標記化物質保持墊41、固定化膜片51及吸收墊61按照該順序連接,在所滴加之液體樣本朝向固定化膜片51依序展開之同時,在該固定化膜片51檢測被檢測物質。 The test strip 21 is a sample dropping pad 31, a labeled substance holding pad 41, an immobilized membrane 51, and an absorption pad 61 connected in this order, and at the same time as the dropped liquid sample is unfolded toward the immobilized membrane 51 in sequence, A substance to be detected is detected on the immobilized membrane 51.
樣本滴加墊31係供滴加包含被檢測物質之液體樣本之部件。在該樣本滴加墊31設置有供滴加液體樣本之滴加部31a。樣本滴加墊31係由與下述標記化物質保持墊41及固定化膜片51相比網眼較粗且吸水性較低之原材料所形成。作為構成樣本滴加墊31之原材料,例如可列舉:尼龍、聚醚碸、聚乙烯醇、聚酯、玻璃纖維、聚烯烴、纖維素、或由它們之混合纖維所形成之無紡布等。又,作為被檢測物質,例如可列舉流行性感冒病毒等抗原等。 The sample dropping pad 31 is a component for dropping a liquid sample containing a test substance. The sample dropping pad 31 is provided with a dropping portion 31 a for dropping a liquid sample. The sample dropping pad 31 is formed of a raw material having a coarser mesh and lower water absorption than the labeled substance holding pad 41 and the immobilized membrane sheet 51 described below. As a raw material constituting the sample drip pad 31, for example, nylon, polyether fluorene, polyvinyl alcohol, polyester, glass fiber, polyolefin, cellulose, or a non-woven fabric formed of a mixed fiber thereof can be cited. Examples of the substance to be detected include antigens such as influenza viruses.
標記化物質保持墊41係含浸有選擇性地結合於被檢測物質且成為標記之標記化物質之部件。該標記化物質保持墊41係液體樣本展開方向之上游側經由界面k11與樣本滴加墊31接觸,夾持於下述之設置於第2盒體91之凸部912與設置於第1盒體81之凸部812之間,且遍及試紙條21之整個寬度方向(與液體樣本展開方向正交之方向)而被該等凸部812、912按壓。上述標記化物質保持墊41接收滴加至樣本滴加墊31之液體樣本,並且使該液體樣本與保持於標記化物質保持墊41內之標記化物質混合,由此,抗原與抗體藉由抗原抗體反應而結合。在本實施形態中,標記化物質遍及上述整個標記化物質保持墊41而均勻地含浸。 The labeled substance holding pad 41 is a component impregnated with the labeled substance to be selectively bound to the substance to be detected. The labeled substance holding pad 41 is located upstream of the liquid sample in the direction of development of the liquid sample, and is in contact with the sample dropping pad 31 via the interface k11. The convex portions 812 of 81 are pressed by the convex portions 812 and 912 throughout the entire width direction of the test strip 21 (a direction orthogonal to the unfolding direction of the liquid sample). The labeled substance holding pad 41 receives a liquid sample added to the sample dropping pad 31 and mixes the liquid sample with the labeled substance held in the labeled substance holding pad 41. Thus, the antigen and the antibody pass through the antigen. The antibody reacts to bind. In this embodiment, the labeled substance is uniformly impregnated throughout the entire labeled substance holding pad 41.
標記化物質保持墊41係由與上述樣本滴加墊31相比網眼較細且吸水性較高之原材料所形成之。由此,能夠使液體樣本從樣本滴加墊 31確實地移動至標記化物質保持墊41。作為構成標記化物質保持墊41之原材料,例如可列舉:尼龍、聚醚碸、聚乙烯醇、聚酯、玻璃纖維、聚烯烴、纖維素、或由它們之混合纖維所形成之無紡布等。 The labeled substance holding pad 41 is formed of a material having a finer mesh and higher water absorption than the sample drip pad 31 described above. Thereby, a liquid sample can be dripped from the sample 31 is reliably moved to the labeled substance holding pad 41. As a raw material constituting the labeled substance holding pad 41, for example, nylon, polyether fluorene, polyvinyl alcohol, polyester, glass fiber, polyolefin, cellulose, or a non-woven fabric formed of a mixed fiber thereof can be cited. .
作為標記化物質,只要選擇性地結合於被檢測物質且經著色,則無特別限定,例如可列舉:物理性或化學性地結合之金膠體、鉑膠體、著色粒子、螢光粒子等不溶性載體粒子、酶標記配體、螢光標記配體等物質。作為上述標記化物質之具體例,例如可例示結合有著色粒子之抗體等。 The labeled substance is not particularly limited as long as it is selectively bound to the substance to be detected and colored, and examples thereof include insoluble carriers such as gold colloid, platinum colloid, colored particles, and fluorescent particles that are physically or chemically bound. Particles, enzyme-labeled ligands, and fluorescent-labeled ligands. Specific examples of the labeled substance include, for example, antibodies to which colored particles are bound.
固定化膜片51係具有將結合有標記化物質之被檢測物質固定之固定化物質之部件。該固定化膜片51具有標記化物質保持墊41之一部分與固定化膜片51之一部分相互重合之部位,具體而言,液體樣本展開方向之上游側經由界面k12與標記化物質保持墊41接觸。上述固定化膜片51接收在標記化物質保持墊41中混合之液體樣本與標記化物質並將其朝向吸收墊61展開。 The immobilized membrane 51 is a member having an immobilized substance that immobilizes a substance to be detected bound with a labeled substance. This immobilized membrane 51 has a portion where a part of the labeled substance holding pad 41 and a part of the immobilized film 51 overlap each other. Specifically, the upstream side of the liquid sample deployment direction is in contact with the labeled substance holding pad 41 via the interface k12. . The immobilized film 51 receives the liquid sample and the labeled substance mixed in the labeled substance holding pad 41 and spreads it toward the absorption pad 61.
具體而言,固定化膜片51係由與上述標記化物質保持墊41相比網眼較細且吸水性較高之原材料所形成。由此,能夠使液體樣本從標記化物質保持墊41確實地移動至固定化膜片51。作為構成固定化膜片51之原材料,例如可列舉:由硝化纖維素等構成之多孔性原材料、由聚酯等構成之纖維原材料等。 Specifically, the immobilized film sheet 51 is made of a material having a finer mesh and higher water absorption than the labeled substance holding pad 41 described above. Thereby, the liquid sample can be reliably moved from the labeled substance holding pad 41 to the immobilized membrane 51. Examples of the material constituting the immobilized membrane sheet 51 include a porous material composed of nitrocellulose and the like, and a fiber material composed of polyester and the like.
又,於固定化膜片51設置有用以檢測被檢測物質之檢測區51a。於該檢測區51a固定有固定化物質,上述固定化物質選擇性地結合於被檢測物質而將該被檢測物質固定於檢測區51a。此處,經固定化之被檢測 物質如上述般結合有標記化物質。因此,藉由將被檢測物質固定於檢測區51a,能夠將經著色之標記化物質蓄積於該檢測區51a,從而能夠藉由以目測辨識顏色或使用檢測裝置檢測標記化物質來判定有無被檢測物質。作為上述固定化物質,例如可列舉抗體等。 In addition, a detection area 51a for detecting a substance to be detected is provided on the immobilized diaphragm 51. An immobilized substance is fixed to the detection region 51a, and the immobilized substance is selectively bound to the substance to be detected to fix the substance to be detected in the detection region 51a. Here, the fixed is detected The substance is bound to a labeled substance as described above. Therefore, by fixing the substance to be detected in the detection region 51a, the colored labeled substance can be accumulated in the detection region 51a, and the presence or absence of the detection can be determined by visually identifying the color or detecting the labeled substance using a detection device. substance. Examples of the immobilized substance include antibodies.
作為檢測區51a之形狀,並無特別限定,例如可如圖2所示,設置成沿與固定化膜片51之樣本展開方向正交之方向延伸設置之帶狀。由此,能夠容易且確實地進行判定。 The shape of the detection area 51a is not particularly limited. For example, as shown in FIG. 2, the shape of the detection area 51 a may be provided in a strip shape extending in a direction orthogonal to the sample unfolding direction of the immobilized membrane 51. Thereby, determination can be performed easily and reliably.
此外,在固定化膜片51上,也可在上述檢測區51a與下述吸收墊61之間設置有用以告知液體樣本已到達之對照區51b。在該情況下,例如,藉由將對照用物質固定於固定化膜片51而形成對照區51b,並且使選擇性地結合於上述對照用物質且結合有標記之對照用標記化物質含浸於標記化物質保持墊41中。藉此,藉由所滴加之液體樣本與對照用標記化物質混合後該混合物到達對照區51b,而使對照用標記化物質被對照用物質固定,從而能夠藉由以目測辨識顏色或使用檢測裝置檢測標記化物質來確認液體樣本已通過檢測區51a(檢查正在正常進行)。 In addition, on the immobilized membrane 51, a control region 51b for notifying that a liquid sample has arrived may be provided between the detection region 51a and the absorption pad 61 described below. In this case, for example, the control region 51b is formed by immobilizing the reference substance on the immobilized membrane 51, and the labeling substance for the control that selectively binds to the above-mentioned reference substance and binds the tag is impregnated with the tag. Chemical substance holding pad 41. Thereby, by mixing the dropped liquid sample with the labeled substance for comparison, the mixture reaches the control region 51b, so that the labeled substance for comparison is fixed by the comparative substance, so that the color can be visually recognized or a detection device can be used. The labeled substance is detected to confirm that the liquid sample has passed through the detection area 51a (the inspection is being performed normally).
吸收墊61係吸收在固定化膜片51中展開之液體樣本之至少一部分之部件。該吸收墊61係該吸收墊61之上游側經由界面k13與固定化膜片51接觸,接收在固定化膜片51中展開之液體樣本等而將其吸收。由於試紙條21具有吸收墊61,因此能夠藉由吸收墊61吸收液體樣本等而促進固定化膜片51中之液體樣本等展開(流動),能夠使滴加至樣本滴加墊31之液體樣本等順利地展開。 The absorption pad 61 is a member that absorbs at least a part of the liquid sample spread in the immobilized membrane 51. The absorption pad 61 is in contact with the immobilized membrane 51 on the upstream side of the absorption pad 61 via the interface k13, and receives the liquid sample or the like spread out in the immobilized membrane 51 and absorbs it. Since the test strip 21 has an absorption pad 61, the liquid sample or the like in the immobilized membrane 51 can be promoted to spread (flow) by absorbing the liquid sample or the like by the absorption pad 61, and the liquid added to the sample dropping pad 31 can be dripped The samples etc. unfolded smoothly.
作為上述吸收墊61,只要能夠吸收大量液體樣本等,則無 特別限定,例如可採用濾紙、由玻璃纖維等所形成之無紡布、吸水性高分子聚合物片材等。 As the absorption pad 61, as long as it can absorb a large amount of a liquid sample or the like, Although it is especially limited, for example, filter paper, a non-woven fabric made of glass fiber, or the like, a water-absorbing polymer sheet, and the like can be used.
襯板71設置於試紙條21與第1盒體81之間,將構成試紙條21之樣本滴加墊31、標記化物質保持墊41、固定化膜片51及吸收墊61一體地固定。具體而言,襯板71是藉由在襯板71之單面設置有黏合劑層71a,且該黏合劑層71a黏合於構成試紙條21之樣本滴加墊31、標記化物質保持墊41、固定化膜片51及吸收墊61,而將該等樣本滴加墊31等一體地固定於襯板71上。作為形成上述襯板71及黏合劑層71a之材料,例如可採用公知之耐水性材料等。這樣一來,藉由該檢查套組11具備襯板71,能夠確實地保持各墊。 The backing plate 71 is provided between the test strip 21 and the first case 81, and integrally fixes the sample dropping pad 31, the labeled substance holding pad 41, the immobilized membrane 51, and the absorption pad 61 constituting the test strip 21 . Specifically, the backing plate 71 is provided with an adhesive layer 71 a on one side of the backing plate 71, and the adhesive layer 71 a is adhered to the sample dropping pad 31 and the labeled substance holding pad 41 constituting the test strip 21. , The film 51 and the absorption pad 61 are immobilized, and the sample dropping pads 31 and the like are integrally fixed to the backing plate 71. As a material for forming the backing plate 71 and the adhesive layer 71a, for example, a known water-resistant material can be used. In this way, by including the backing plate 71 in the inspection set 11, each pad can be reliably held.
第1盒體81載置試紙條21。第2盒體91以介隔試紙條21與第1盒體81對向之方式配置而夾持試紙條21。作為構成該等第1及第2盒體81、91之材料,例如可採用聚丙烯、ABS等。 The first case 81 holds a test strip 21. The second case body 91 is disposed so as to face the first case body 81 with the test strip 21 therebetween, and holds the test strip 21. As a material constituting the first and second cases 81 and 91, for example, polypropylene, ABS, and the like can be used.
此處,在上述襯板71與第1盒體81之間之至少一部分設置有間隙g。如圖1所示,該間隙g是藉由襯板71之下表面抵接於設置在第1盒體81之凸部811~813之末端而形成。作為間隙g之間隔,較佳為形成為進入該間隙g之液體樣本等不會因表面張力而擴散之程度。作為該間隙g之間隔,較佳為0.1mm以上,更佳為0.5mm以上。由此,能夠抑制液體樣本滲入試紙條21與第1盒體81之間,從而能夠抑制上述液體樣本之損耗以確實地檢測出有無被檢測物質。 Here, a gap g is provided in at least a part of the backing plate 71 and the first case 81. As shown in FIG. 1, the gap g is formed by the lower surface of the backing plate 71 abutting on the ends of the convex portions 811 to 813 provided on the first case 81. The interval of the gap g is preferably such that a liquid sample or the like entering the gap g does not spread due to surface tension. The interval g is preferably 0.1 mm or more, and more preferably 0.5 mm or more. As a result, it is possible to suppress the penetration of the liquid sample between the test strip 21 and the first case 81, and it is possible to suppress the loss of the liquid sample and reliably detect the presence or absence of the substance to be detected.
在第2盒體91設置有按壓部910,該按壓部910只對標記化物質保持墊41之一部分與固定化膜片51之一部分相互重合之部位中之 與液體樣本展開方向正交之方向上之一部分進行按壓(參照圖2)。具體而言,按壓部910是藉由在第2盒體91設置凸部911而形成,上述凸部911是以只對重合部位中之與液體樣本展開方向正交之方向上之兩端部進行按壓之方式配設。 The second case 91 is provided with a pressing portion 910, and the pressing portion 910 only covers a portion where a portion of the labeled substance holding pad 41 and a portion of the immobilized membrane 51 overlap each other. A part of the direction orthogonal to the unfolding direction of the liquid sample is pressed (see FIG. 2). Specifically, the pressing portion 910 is formed by providing a convex portion 911 on the second case 91, and the convex portion 911 is performed only on both ends of the overlapping portion in a direction orthogonal to the direction in which the liquid sample is unfolded. Configured by pressing.
藉由以這種方式設置有按壓部910,能夠使標記化物質保持墊41與固定化膜片51密接,能夠使液體樣本等確實且順利地從標記化物質保持墊41向固定化膜片51展開。又,藉由上述按壓部910(凸部911)以按壓上述兩端部之方式配設,能夠相對於展開方向對稱地按壓重合部位,從而能夠使液體樣本在固定化膜片51內朝向吸收墊61平衡性良好地展開。 By providing the pressing portion 910 in this manner, the labeled substance holding pad 41 can be brought into close contact with the immobilized membrane sheet 51, and a liquid sample or the like can be reliably and smoothly moved from the labeled substance holding pad 41 to the immobilized membrane sheet 51. Expand. In addition, the pressing portion 910 (convex portion 911) is disposed so as to press the two end portions, so that the overlapping portion can be pressed symmetrically with respect to the deployment direction, so that the liquid sample can be directed toward the absorption pad in the immobilized membrane 51 61 Unfolded well.
又,在第2盒體91設置有用以將液體樣本投入至該檢查套組11之樣本投入口914。該樣本投入口914在第2盒體91中之面對樣本滴加墊31之滴加部31a之位置開口,能夠經由樣本投入口914將液體樣本投入至滴加部31a。 The second case 91 is provided with a sample input port 914 for feeding a liquid sample into the inspection set 11. The sample input port 914 is opened at a position facing the dripping portion 31a of the sample dropping pad 31 in the second case 91, and a liquid sample can be input into the dripping portion 31a through the sample input port 914.
又,第2盒體91具備用以從外部確認被檢測物質之檢測之窗部915,該窗部915配置於面對固定化膜片51之部位、同時也是面對被按壓部910按壓之部位正下方之液體樣本展開之流域R以外之流域P之部位。作為該窗部915,例如可採用以下構成等:在第2盒體91形成有開口;配置對於可見光透明之部件、當標記化物質發出螢光時使該螢光透過之部件。此外,在本實施形態中,使用在第2盒體91形成有開口之窗部915。 In addition, the second case 91 includes a window portion 915 for externally confirming detection of the detected substance, and the window portion 915 is disposed at a portion facing the immobilized diaphragm 51 and also at a portion facing the pressed portion 910. The part of the watershed P other than the watershed R where the liquid sample immediately below is expanded. As the window portion 915, for example, an opening may be formed in the second case 91, a member transparent to visible light, and a member that transmits the fluorescent light when the labeled substance emits fluorescent light may be arranged. In the present embodiment, a window portion 915 having an opening formed in the second case 91 is used.
此外,就更加確實地判定有無被檢測物質之觀點而言,較佳為將流域R以無法從外部確認被檢測物質之檢測之方式遮蔽。作為這種態 樣,例如可列舉:第1及/或第2盒體無法辨識在流域R中展開之標記化物質之顏色之態樣(例如盒體不透明、在盒體上印刷文字或記號、或者貼附標籤等)或由阻礙使用檢測裝置檢測標記化物質之材料所構成之態樣、或者流域R被阻礙顏色辨識或使用檢測裝置檢測標記化物質之部件(第1及第2盒體以外之遮蔽部件)覆蓋之態樣等。作為阻礙上述檢測之材料或部件,例如可列舉阻礙檢測所必需之特定波長透過之材料或部件等。 In addition, from the viewpoint of more accurately determining the presence or absence of a substance to be detected, it is preferable that the watershed R is shielded so that the substance to be detected cannot be detected from the outside. As this state For example, the first and / or second boxes cannot recognize the color of the labeled substance spread in the watershed R (for example, the box is opaque, the words or marks are printed on the box, or the label is attached Etc.) or a component made of a material that prevents the use of a detection device to detect the labeling substance, or a component in which the watershed R is blocked from color recognition or a detection device that detects the labeling substance (a shielding member other than the first and second cases) Coverage, etc. Examples of materials or components that prevent the above detection include materials or components that prevent transmission of a specific wavelength necessary for detection.
接下來,對使用本實施形態之檢測套組11之被檢測物質之檢測方法進行說明。此處,對以下之示例進行說明:使用抗原作為被檢測物質,使用結合有著色粒子之抗體作為標記化物質,使用抗體作為固定化物質,並且在標記化物質保持墊41中具有作為對照用標記化物質之結合有著色粒子之抗體(與固定化物質中之抗體不同之抗體),在對照區51b中具有作為對照用物質之抗原(與被檢測物質中之抗原不同之抗原)。此外,作為被檢測物質之抗原及標記化物質中所包含之抗體、以及作為被檢測物質之抗原及作為固定化物質之抗體、以及對照用標記化物質中所包含之抗體及作為對照用物質之抗原分別藉由抗原抗體反應而結合。 Next, a method for detecting a substance to be detected using the detection kit 11 according to this embodiment will be described. Here, an example will be described in which an antigen is used as a substance to be detected, an antibody to which colored particles are bound is used as a labeling substance, an antibody is used as an immobilized substance, and a label as a control is provided in the labeled substance holding pad 41. The antibody to which the colored substance binds (the antibody different from the antibody in the immobilized substance) has an antigen as a control substance (an antigen different from the antigen in the test substance) in the control region 51b. In addition, the antigen contained in the test substance and the antibody contained in the labeled substance, the antigen used as the test substance and the antibody as the immobilized substance, and the antibody contained in the labeled substance for the control and the substance used as the control Antigens are bound by antigen-antibody reactions, respectively.
首先,準備液體樣本,經由檢查套組11之樣本投入口914將適量液體樣本投入至樣本滴加墊31之滴加部31a後,該液體樣本滲透至樣本滴加墊31,其一部分朝向標記化物質保持墊41展開。 First, a liquid sample is prepared, and an appropriate amount of liquid sample is injected into the dripping portion 31a of the sample drip pad 31 through the sample input port 914 of the inspection set 11. The liquid sample penetrates into the sample drip pad 31, and a part of the liquid sample faces the marking The substance holding pad 41 is deployed.
接下來,到達界面k11之液體樣本經由該界面k11滲透至標記化物質保持墊41中,該滲透之液體樣本朝向固定化膜片51展開。此時,液體樣本與含浸在標記化物質保持墊41中之標記化物質及對照用標記化物質混合,在液體樣本中包含抗原之情況下,藉由抗原抗體反應與標記化物 質中之抗體結合,在該狀態下與標記化物質一同朝向固定化膜片51展開。 Next, the liquid sample reaching the interface k11 penetrates into the labeled substance holding pad 41 through the interface k11, and the penetrated liquid sample is developed toward the immobilized membrane 51. At this time, the liquid sample is mixed with the labeling substance and the reference labeling substance impregnated in the labeling substance holding pad 41, and when the liquid sample contains the antigen, the labeling substance is reacted with the antigen-antibody reaction. The antibody in the substrate is bound and unfolded toward the immobilized membrane 51 together with the labeled substance in this state.
接下來,到達界面k12之液體樣本等經由該界面k12滲透至固定化膜片51中。此時,由於標記化物質保持墊41與固定化膜片51被凸部911按壓而密接,因此,液體樣本等快速展開至固定化膜片51。接下來,展開至固定化膜片51之液體樣本等朝向吸收墊61展開,依序通過設置於固定化膜片51之檢測區51a及對照區51b。 Next, a liquid sample or the like reaching the interface k12 penetrates through the interface k12 into the immobilized membrane 51. At this time, since the labeled substance holding pad 41 and the immobilized membrane sheet 51 are pressed and brought into close contact with each other by the convex portion 911, a liquid sample or the like is quickly developed to the immobilized membrane sheet 51. Next, the liquid sample or the like expanded to the immobilized membrane 51 is unfolded toward the absorption pad 61 and sequentially passes through the detection area 51 a and the control area 51 b provided in the immobilized membrane 51.
檢測區51a中,在液體樣本中包含抗原之情況下與標記化物質結合之抗原進一步藉由含浸於檢測區51a之固定化物質結合而固定。雖然藉由該固定而使經著色之標記化物質蓄積於檢測區51a,但該檢查套組11在固定化膜片51中之液體樣本展開之流域、同時也係被按壓部910按壓之部位正下方之液體樣本展開之流域R以外之流域P,能夠經由窗部915從外部確認(目測或使用檢測裝置確認)被檢測物質之檢測,因此能夠判定有無抗原。 In the detection area 51a, when the liquid sample contains the antigen, the antigen bound to the labeling substance is further fixed by binding with the immobilization substance impregnated in the detection region 51a. Although the colored marker substance is accumulated in the detection area 51a by the fixation, the flow area where the liquid sample in the immobilization membrane 51 is unfolded by the inspection set 11 is also a part pressed by the pressing part 910. The watershed P other than the watershed R where the lower liquid sample spreads can be externally confirmed (visually or confirmed using a detection device) through the window 915 to detect the detection substance, and therefore the presence or absence of an antigen can be determined.
另一方面,液體樣本等之一部分通過檢測區51a而到達對照區51b,在標記化物質保持墊41中混合於液體樣本之對照用標記化物質與在對照區51b中固定之對照用物質結合而固定化。與此同時,對照用標記化物質蓄積於對照區51b,因此,能夠透過經由窗部915以目測確認對照區51b有無顏色來辨識液體樣本已通過檢測區51a(檢查正在正常進行)。接下來,液體樣本等之一部分通過對照區51b而被吸收墊61吸收。 On the other hand, a portion of the liquid sample or the like passes through the detection area 51a to reach the control area 51b, and the labeled substance for comparison mixed with the liquid sample in the labeled substance holding pad 41 is combined with the reference substance fixed in the control area 51b. Immobilized. At the same time, since the labeled substance for comparison is accumulated in the comparison area 51b, the presence or absence of the color of the comparison area 51b can be visually confirmed through the window portion 915 to recognize that the liquid sample has passed through the detection area 51a (the inspection is being performed normally). Next, a part of the liquid sample or the like is absorbed by the absorption pad 61 through the control area 51b.
順帶一提,在液體樣本等從標記化物質保持墊41展開至固定化膜片51中時,標記化物質有時會在固定化膜片51中一下子大量展開。該現象容易在液體樣本等最後通過界面k12時產生。如果產生該現象,那 麼標記化物質濃度較高之特定區域會在固定化膜片51中移動,也可能會導致誤判定。即,儘管不存在被測定物質(抗原),但在固定化膜片51中引發彷彿存在被測定物質(抗原)似之著色。 Incidentally, when a liquid sample or the like is unfolded from the labeled substance holding pad 41 into the immobilized membrane sheet 51, the labeled substance may be unfolded in a large amount at once in some cases. This phenomenon easily occurs when a liquid sample or the like finally passes through the interface k12. If this happens, then Therefore, a specific region with a higher concentration of the labeling substance may move in the immobilized film 51, and may also cause erroneous determination. That is, although the substance to be measured (antigen) is absent, the immobilization membrane 51 causes coloring as if the substance to be measured (antigen) is present.
然而,由於該檢查套組11具備對重合部位中之與液體樣本展開方向正交之方向上之一部分進行按壓之按壓部,在固定化膜片51中之液體樣本展開之流域、同時也是被按壓部910按壓之部位正下方之液體樣本展開之流域R以外之流域P,能夠從外部確認被檢測物質之檢測,因此至少能夠從外部觀察發生未伴隨有按壓部910之按壓之標記化物質之穩定展開之流域,從而能夠確實地判定有無被檢測物質。此外,推測藉由按壓重合部位而使液體樣本等一下子大量展開之原因在於:液體樣本等容易滯留於界面k12中之上述被按壓之部位,該滯留之液體樣本等最後通過時會一下子展開(放出)。 However, since the inspection set 11 includes a pressing portion that presses a portion of the overlapped portion in a direction orthogonal to the direction in which the liquid sample is unfolded, the area where the liquid sample in the fixed membrane 51 is unfolded is also pressed. The watershed P other than the watershed R where the liquid sample directly under the part pressed by the part 910 can confirm the detection of the detected substance from the outside, so at least the stability of the labeled substance that is not accompanied by the pressing of the pressing part 910 can be observed from the outside. The unfolded watershed can accurately determine the presence or absence of a substance to be detected. In addition, it is presumed that the reason why the liquid sample and the like are unfolded in a large amount by pressing the overlapping portion is that the liquid sample and the like are liable to stay in the above-mentioned pressed portion in the interface k12, and the retained liquid sample and the like are unfolded at the last passage (release).
[第2實施形態] [Second Embodiment]
圖5係表示本發明之第2實施形態之概略縱剖面圖。又,圖6係圖5之概略俯視圖。如圖5及圖6所示,該檢查套組12概略性地包括:具有樣本滴加墊31、標記化物質保持墊42、固定化膜片51及吸收墊61之試紙條22、襯板71、第1盒體81、及第2盒體91。 Fig. 5 is a schematic longitudinal sectional view showing a second embodiment of the present invention. 6 is a schematic plan view of FIG. 5. As shown in FIG. 5 and FIG. 6, the inspection kit 12 roughly includes a test strip 22 including a sample dropping pad 31, a labeled substance holding pad 42, an immobilized membrane 51 and an absorption pad 61, and a lining plate. 71. The first case 81 and the second case 91.
在本實施形態中,標記化物質保持墊42之構成與第1實施形態不同。此外,由於樣本滴加墊31、固定化膜片51、吸收墊61、襯板71、第1盒體81及第2盒體91之構成與第1實施形態之此等部件相同,因此對相同部分標注相同符號並省略其詳細說明。又,由於標記化物質保持墊42之構成係除了標記化物質之含有部分不同以外,與第1實施形態之 標記化物質保持墊相同,因此省略上述含有部分之說明以外之詳細說明。 In this embodiment, the configuration of the labeled substance holding pad 42 is different from that of the first embodiment. In addition, since the sample dropping pad 31, the immobilized membrane 51, the absorption pad 61, the backing plate 71, the first case 81, and the second case 91 have the same configuration as those of the first embodiment, they are the same. Parts are marked with the same symbols and detailed descriptions are omitted. In addition, the structure of the labeled substance holding pad 42 is different from that of the first embodiment except that the content of the labeled substance holding pad 42 is different. Since the labeled substance holding pads are the same, detailed explanations other than the description of the above-mentioned contained portions are omitted.
標記化物質保持墊42係含浸有選擇性地結合於被檢測物質且成為標記之標記化物質之部件。本實施形態之標記化物質保持墊42具有包含標記化物質之含有部分42a以及與該含有部分42a鄰接且不包含標記化物質之未含有部分42b,樣本滴加墊31與未含有部分42b連接,含有部分42a之至少一部分與固定化膜片51連接。 The labeled substance holding pad 42 is a component impregnated with a substance to be selectively bound to a test substance and becomes a labeled labeled substance. The labeled substance holding pad 42 of this embodiment has a containing portion 42a containing the labeled substance and an uncontaining portion 42b adjacent to the containing portion 42a and containing no labeled substance, and the sample dropping pad 31 is connected to the non-containing portion 42b. At least a part of the containing portion 42 a is connected to the immobilized membrane 51.
本實施形態之標記化物質保持墊42中,只要至少界面k21整體與未含有部分42b接觸即可。又,標記化物質保持墊42中之標記化物質之含有部分42a與未含有部分42b之比率(例如體積比等)只要滿足上述構成,則無特別限定,可取各種比率。 In the labeled substance holding pad 42 of this embodiment, it is sufficient that at least the entire interface k21 is in contact with the non-containing portion 42b. The ratio (for example, volume ratio) of the contained portion 42a to the uncontaining portion 42b of the labeled substance in the labeled substance holding pad 42 is not particularly limited as long as it satisfies the above configuration, and various ratios can be adopted.
接下來,對使用本實施形態之檢測套組12之被檢測物質之檢測方法進行說明。此外,此處,對發揮與第1實施形態中所說明之檢測方法之作用不同之作用之部分進行說明。 Next, a method for detecting a substance to be detected using the detection kit 12 according to this embodiment will be described. In addition, here, a part that exerts a function different from that of the detection method described in the first embodiment will be described.
首先,經由檢查套組12之樣本投入口914將適量液體樣本投入至樣本滴加墊31之滴加部31a後,該液體樣本滲透至樣本滴加墊31,其一部分朝向標記化物質保持墊42展開。 First, an appropriate amount of a liquid sample is injected into the dripping portion 31 a of the sample drip pad 31 through the sample input port 914 of the inspection set 12, and the liquid sample penetrates into the sample drip pad 31, and a part thereof faces the labeled substance holding pad 42. Expand.
接下來,到達界面k21之液體樣本經由該界面k21展開至標記化物質保持墊42中,該展開之液體樣本一邊與標記化物質及對照用標記化物質混合,一邊和此等物質一起朝向固定化膜片51展開。此時,該檢查套組12僅標記化物質保持墊42中之不包含標記化物質之未含有部分42b與樣本滴加墊31接觸,因此,界面k21中不會滯留標記化物質,不會發生因界面k21之滯留所導致之標記化物質一下子大量展開,相應地,能夠抑 制被檢測物質之誤判定,能夠更加確實地判定有無被檢測物質。 Next, the liquid sample reaching the interface k21 is developed into the labeled substance holding pad 42 through the interface k21. The expanded liquid sample is mixed with the labeled substance and the control labeled substance while being fixed with the substances. The diaphragm 51 is unfolded. At this time, only the non-containing portion 42b of the labeled substance holding pad 42 that does not contain the labeled substance is in contact with the sample dropping pad 31 in the inspection kit 12, and therefore, the labeled substance is not retained in the interface k21 and does not occur. Due to the retention of the interface k21, a large amount of labeled substances are unfolded at once, and accordingly, The erroneous determination of the detection substance can more accurately determine the presence or absence of the detection substance.
接下來,到達界面k22之液體樣本等經由該界面k22展開至固定化膜片51中,以下,以與上述第1實施形態相同之方式進行。 Next, a liquid sample or the like reaching the interface k22 is developed into the immobilized membrane 51 via the interface k22, and the following is performed in the same manner as in the first embodiment described above.
[第3實施形態] [Third Embodiment]
圖7係表示本發明之第3實施形態之概略縱剖面圖。又,圖8係圖7之概略俯視圖。如圖7及圖8所示,該檢查套組13概略性地包括:具有樣本滴加墊31、標記化物質保持墊43、固定化膜片51及吸收墊61之試紙條23、襯板71、第1盒體83、及第2盒體93。 Fig. 7 is a schematic longitudinal sectional view showing a third embodiment of the present invention. 8 is a schematic plan view of FIG. 7. As shown in FIG. 7 and FIG. 8, the inspection set 13 roughly includes a test strip 23 including a sample dropping pad 31, a labeled substance holding pad 43, an immobilized membrane 51 and an absorption pad 61, and a lining plate. 71. The first case 83 and the second case 93.
在本實施形態中,樣本滴加墊31、標記化物質保持墊43及固定化膜片51重合之構成與第1實施形態不同。此外,由於樣本滴加墊31等各部件之構成與第1實施形態之各部件之構成相同,因此此等部件之說明引用第1實施形態之說明而省略。 In this embodiment, the configuration in which the sample dropping pad 31, the labeled substance holding pad 43 and the immobilized membrane 51 are superimposed is different from the first embodiment. In addition, since the components of the components such as the sample dropping pad 31 are the same as those of the first embodiment, the description of these components is omitted by referring to the description of the first embodiment.
在本實施形態中,試紙條23之重合部位係至少樣本滴加墊31之一部分、標記化物質保持墊43之一部分、及固定化膜片51之一部分按照該順序積層之構造。在本實施形態中,該檢查套組13在襯板71上積層有固定化膜片51、標記化物質保持墊43及樣本滴加墊31,該等3層構造之部件一體地夾持於凸部831與凸部931(按壓部930)之間。 In this embodiment, the overlapping portion of the test strip 23 has a structure in which at least a portion of the sample drip pad 31, a portion of the labeled substance holding pad 43 and a portion of the immobilized membrane 51 are laminated in this order. In this embodiment, the inspection set 13 has a fixed film 51, a labeled substance holding pad 43 and a sample dropping pad 31 laminated on a backing plate 71. The three-layer structured components are integrally held on the projections. Between the portion 831 and the convex portion 931 (pressing portion 930).
其次,對使用本實施形態之檢測套組13之被檢測物質之檢測方法進行說明。此外,此處對發揮與第1實施形態中所說明之檢測方法之作用不同之作用之部分進行說明。 Next, a method for detecting a substance to be detected using the detection set 13 of the present embodiment will be described. In addition, a part that exerts a function different from that of the detection method described in the first embodiment will be described here.
首先,經由檢查套組13之樣本投入口914將適量液體樣本投入至樣本滴加墊31之滴加部31a後,該液體樣本滲透至樣本滴加墊31, 其一部分朝向標記化物質保持墊43展開。 First, after an appropriate amount of a liquid sample is put into the dropping portion 31a of the sample dropping pad 31 through the sample dropping port 914 of the inspection set 13, the liquid sample penetrates into the sample dropping pad 31, A part of it is unfolded toward the labeled substance holding pad 43.
接下來,到達界面k31之液體樣本經由該界面k31展開至標記化物質保持墊43中後,一邊與標記化物質及對照用標記化物質混合,一邊經由界面k32展開至固定化膜片51中。此時,該檢查套組13係樣本滴加墊31、標記化物質保持墊43及固定化膜片51成為上述3層構造,且被成為按壓部930之凸部931一體地按壓,因此,能夠使上述樣本滴加墊31等以簡易之構成一體地緊貼,從而能夠促進液體樣本等展開以迅速且確實地檢測有無被檢測物質。 Next, the liquid sample reaching the interface k31 is developed into the labeled substance holding pad 43 through the interface k31, and then mixed with the labeled substance and the control labeled substance, and then developed into the immobilized membrane 51 through the interface k32. At this time, the inspection set 13 is a sample dropping pad 31, a labeled substance holding pad 43, and an immobilized membrane 51 having the above-mentioned three-layer structure, and is integrally pressed by the convex portion 931 serving as the pressing portion 930. The sample drip pad 31 and the like are brought into close contact with each other with a simple structure, so that the development of the liquid sample and the like can be promoted to quickly and reliably detect the presence or absence of a substance to be detected.
接下來,到達界面k32之液體樣本等經由該界面k32滲透至固定化膜片51中,以下,以與上述第1實施形態相同之方式進行。 Next, a liquid sample or the like reaching the interface k32 penetrates through the interface k32 into the immobilized membrane 51, and the following is performed in the same manner as in the first embodiment described above.
<被檢測物質之檢測方法> <Detection method of test substance>
本發明之被檢測物質之檢測方法使用了檢查套組,該檢查套組具備試紙條,該試紙條係樣本滴加墊、標記化物質保持墊以及固定化膜片按照該順序連接,上述樣本滴加墊供滴加包含被檢測物質之液體樣本,上述記化物質保持墊含浸有選擇性地結合於上述被檢測物質且成為標記之標記化物質,上述固定化膜片具有將結合有上述標記化物質之被檢測物質固定之固定化物質,且在所滴加之上述液體樣本朝向上述固定化膜片依序展開之同時,在該固定化膜片檢測上述被檢測物質;且上述被檢測物質之檢測方法之特徵在於:上述試紙條具有至少標記化物質保持墊之一部分與固定化膜片之一部分相互重合之部位,上述檢查套組具備按壓部,該按壓部對上述重合部位中之與上述液體樣本展開方向正交之方向上之一部分進行按壓,在上述固定化膜片中之上述液體樣本展開之流域、同時也係被上述按壓部 按壓之部位正下方之上述液體樣本展開之流域以外之流域,能夠從外部確認上述被檢測物質之檢測。 The method for detecting a substance to be tested according to the present invention uses a test kit provided with a test strip, which is a sample drip pad, a labeled substance holding pad, and an immobilized membrane connected in this order. The sample dropping pad is used for dropping a liquid sample containing a substance to be detected. The chemical substance holding pad is impregnated with a labeled substance that selectively binds to the substance to be detected and becomes a mark. The immobilized membrane has The immobilized substance to which the substance to be detected is immobilized, and while the liquid sample being dropped is sequentially developed toward the immobilized membrane, the detected substance is detected on the immobilized membrane; and the detected substance The detection method is characterized in that the test strip has a portion where at least a portion of the labeled substance holding pad and a portion of the immobilized membrane overlap with each other, and the inspection kit includes a pressing portion which is pressed against the overlapping portion. The liquid sample is pressed in a direction orthogonal to the unfolding direction of the liquid sample, and the liquid sample in the immobilized diaphragm is pressed. Expand the basin, while the pressing portion is also based It is possible to externally confirm the detection of the detected substance in a watershed other than the one in which the above-mentioned liquid sample is spread directly under the pressed part.
此外,由於該被檢測物質之檢測方法之詳細說明與上述<檢查套組>項中之[第1實施形態]中之說明相同,因此引用上述說明而省略此處之說明。 In addition, since the detailed description of the detection method of the substance to be detected is the same as that described in [First Embodiment] in the above <Inspection Set>, the above description is cited and the description here is omitted.
此外,本發明不限定於上述實施形態之構成而由申請專利範圍表示,意圖包含與申請專利範圍均等之含義及範圍內之所有變更。 In addition, the present invention is not limited to the constitution of the above-mentioned embodiment but is expressed by the scope of patent application, and is intended to include all changes within the meaning and scope equivalent to the scope of patent application.
例如,雖在上述實施形態中,對具備第1及第2盒體之檢查套組11~13進行了說明,但不具備此等盒體之檢查套組也包含於本發明意圖之範圍內。作為這種態樣,例如可列舉使用夾具等夾持手段按壓上述重合部位之一部分之檢查套組等。 For example, although the inspection kits 11 to 13 provided with the first and second cassettes have been described in the above embodiment, inspection kits without such cassettes are also included in the scope of the present invention. Examples of such an aspect include an inspection kit that presses a part of the overlapped portion using a clamping means such as a clamp.
又,在使用上述夾持手段或遮蔽部件之情況下,也可將使用有此等手段或部件之試紙條用其他盒體(第1及第2盒體以外之盒體)來包持。 When the above-mentioned holding means or shielding member is used, the test strip using these means or members may be held in another case (cases other than the first and second cases).
又,雖在上述實施形態中,對按壓部910、920、930是以對重合部位中之與液體樣本展開方向正交之方向(試紙條之寬度方向)上之兩端部進行按壓之方式配設之檢查套組11、12、13進行了說明,但只要按壓部對重合部位中之與液體樣本展開方向正交之方向上之一部分進行按壓,則無特別限定,例如也可為按壓部是以對試紙條之寬度方向上之中央部進行按壓之方式設置之檢查套組。 Moreover, in the above-mentioned embodiment, the pressing portions 910, 920, and 930 are used to press the two end portions in the direction (the width direction of the test strip) orthogonal to the direction in which the liquid sample is unfolded in the overlapping portion. The provided inspection kits 11, 12, and 13 are described, but as long as the pressing portion presses a portion of the overlapping portion in a direction orthogonal to the direction in which the liquid sample is unfolded, it is not particularly limited, and may be, for example, a pressing portion It is an inspection set provided by pressing the central part in the width direction of the test strip.
又,雖在上述實施形態中,對具備吸收墊61之檢查套組11~13進行了說明,但只要滴加至樣本滴加墊31之液體樣本等朝向固定化膜 片51順利地展開,則不具備上述吸收墊61之檢查套組也包含於本發明意圖之範圍內。 In addition, although the inspection kits 11 to 13 provided with the absorption pad 61 have been described in the above embodiment, as long as the liquid sample or the like dropped on the sample dropping pad 31 faces the immobilized film, The sheet 51 is unfolded smoothly, and the inspection kit without the absorption pad 61 is also included in the scope of the present invention.
又,雖在上述實施形態中,對樣本滴加墊31與標記化物質保持墊41、42被凸部912、922遍及試紙條21、22之寬度方向(與液體樣本展開之方向正交之方向)整體而按壓之檢查套組11、12進行了說明,但按壓樣本滴加墊及標記化物質保持墊之部位也可為試紙條之寬度方向上之一部分(與液體樣本展開之方向正交之方向上之一部分)。 Moreover, in the above-mentioned embodiment, the sample dropping pad 31 and the labeled substance holding pads 41 and 42 have convex portions 912 and 922 throughout the width direction of the test strips 21 and 22 (orthogonal to the direction in which the liquid sample is unfolded). (Direction)) The inspection kits 11 and 12 which are pressed as a whole are described, but the position where the sample drip pad and the labeled substance holding pad are pressed may be a part of the width direction of the test strip (positive to the direction in which the liquid sample is unfolded). Part of the direction of intersection).
該等之中,在遍及標記化物質保持墊整體而均勻地含浸標記化物質之檢查套組之情況下,上述按壓之部位940較佳為例如圖4所示為在液體樣本展開之正下方之流域R1未設置窗部915之部位。由此,能夠進一步降低因樣本滴加墊與標記化物質保持墊之界面上之標記化物質滯留所導致之誤判定,能夠更加確實地判定有無被檢測物質。 Among these, in the case of a test kit that is uniformly impregnated with the labeling substance throughout the entirety of the labeling substance holding pad, the above-mentioned pressed part 940 is preferably, for example, as shown in FIG. 4 directly below the unfolding of the liquid sample. The part of the river basin R1 is not provided with the window portion 915. Thereby, it is possible to further reduce the erroneous determination caused by the retention of the labeled substance on the interface between the sample dropping pad and the labeled substance holding pad, and it is possible to more accurately determine the presence or absence of the substance to be detected.
又,雖在上述實施形態中,對具備襯板71之檢查套組11~13進行了說明,但只要樣本滴加墊、標記化物質保持墊及固定化膜片滿足上述關係且不損及本發明之效果,則也可為不具備襯板71之檢查套組。 In addition, although the inspection kits 11 to 13 including the backing plate 71 have been described in the above embodiment, as long as the sample dropping pad, the labeled substance holding pad, and the immobilized membrane satisfy the above-mentioned relationship, the present invention is not damaged. The effect of the invention can also be an inspection kit without the backing plate 71.
又,雖在上述實施形態中,對樣本投入口914及窗部915均設置於第2盒體91、93之檢查套組11~13進行了說明,但此等之中之至少任一個設置於第1盒體之檢查套組也包含於本發明意圖之範圍內。 In addition, in the above embodiment, it has been described that the sample inlets 914 and the window portions 915 are provided in the inspection sets 11 to 13 of the second cases 91 and 93, but at least one of these is provided in The inspection kit of the first case is also included in the scope of the present invention.
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