CN203688562U - Two-step method immunochromatography testing device - Google Patents

Two-step method immunochromatography testing device Download PDF

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Publication number
CN203688562U
CN203688562U CN201420045235.8U CN201420045235U CN203688562U CN 203688562 U CN203688562 U CN 203688562U CN 201420045235 U CN201420045235 U CN 201420045235U CN 203688562 U CN203688562 U CN 203688562U
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China
Prior art keywords
pad
sample
label
plastics
transition
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CN201420045235.8U
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Chinese (zh)
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林志铿
陈波
周敏
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XIAMEN WEIZHENG BIOLOGICAL SCIENCE & TECHNOLOGY Co Ltd
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XIAMEN WEIZHENG BIOLOGICAL SCIENCE & TECHNOLOGY Co Ltd
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Abstract

The utility model relates to a two-step method immunochromatography testing device which comprises a chromatography membrane, a substrate support, a water absorbing pad, a transition pad, a sample pad, a mark pad, a waterproof isolation layer, an internal plastic member and an external plastic member, wherein the chromatography membrane is adhered on the substrate support located in the internal plastic member, the water absorbing pad is adhered on one end of the substrate support and is lapped with the chromatography membrane, the transition pad is adhered on the other end of the substrate support and is lapped with the chromatography membrane, the sample pad and the mark pad are respectively arranged at the upper part in the internal plastic member and are separated from the transition pad through the waterproof isolation layer, the outer side of the internal plastic member is sleeved with the external plastic member in a sliding matching manner, and any one end part of the internal plastic member is exposed. The two-step method immunochromatography testing device is simple to operate, high in sensitivity, full and controllable in reaction, good in stability, good in repeatability, easy to identify, capable of performing qualitative detecting and quantitative detecting, and beneficial to rapid bedside diagnosis of people.

Description

A kind of two-step approach immune chromatograph testing device
Technical field
The utility model relates to a kind of two-step approach immuno-chromatography detection device.
Background technology
Traditional lateral chromatography detecting pattern used comprises five assemblies, be respectively sample pad, label pad, chromatographic film, adsorptive pads and base plate holder, there is following shortcoming: (1) sample drop arrives label pad by capillary siphoning effect chromatography after being added to sample pad, because labelled antibody is to be dried to be in advance fixed in label pad, therefore the detection thing in sample is in dissolving labelled antibody, to react with the labelled antibody in label pad to form labeled complex B, but because reaction is insufficient, sample reacts the productive rate that becomes labeled complex B with labelled antibody have an efficiency, simultaneously labeled complex B in chromatographic film chromatography to detection line position, again with detection line on antibody response, form double antibodies sandwich type compound C, and only have the compound of formation C to be only effective reaction signal, but the unreacted antigen of labeled complex B and sample can compete with detection line on antibody response, therefore there is equally joint efficiency problem in the formation of compound C.The useful signal of visible compound C is that the efficiency of compound B is taken advantage of in the reaction efficiency of compound B and detection line antibody again, and therefore sensitivity is low.(2) because labelled antibody is to be fixed in label pad, therefore in the time of sample dissolution labelled antibody, most label is all along with sample directly washes away through chromatographic film, and cannot with detection line on antibody generation effecting reaction, therefore compound C is not produced to contribution.
Utility model content
The defect existing in order to overcome existing immunochromatography pattern, the purpose of this utility model is to provide a kind of simple to operate, two-step approach immuno-chromatography detection device of being easy to identification, both can qualitative detection, also can quantitatively detect.
To achieve these goals, the technical solution of the utility model is: a kind of two-step approach immuno-chromatography detection device, comprise chromatographic film, backplanes support thing, adsorptive pads, transition pad, sample pad, label pad, watertight insulation, inner working of plastics and outer plastic part, described chromatographic film sticks on the backplanes support thing that is positioned at inner working of plastics, described adsorptive pads sticks to one end of backplanes support thing and overlaps with chromatographic film, described transition pad sticks to the other end of backplanes support thing and overlaps with chromatographic film, described sample pad and label pad are arranged on respectively selects one between top in inner working of plastics and the two and transition pad and separates by watertight insulation, described outer plastic part is sheathed on outside inner working of plastics with sliding matching mode and exposes arbitrary end of inner working of plastics.
Further, described watertight insulation is isolated label pad and transition pad initial keeping right when position, and sample pad and transition pad are overlapped; Described watertight insulation slides into left while keeping left position isolates sample pad and transition pad, and label pad and transition pad are overlapped.
Further, described outer plastic part is connected with watertight insulation, and described outer plastic part drives watertight insulation to horizontally slip outward in the time that inner working of plastics horizontally slips, and makes sample pad and label pad alternately by transition pad and chromatographic film overlap joint.
Further, on described inner working of plastics, offer be convenient to sample pad add sample sample pipetting volume hole, be convenient to add the dilution well of dilution and be convenient to observe the interior view window of chromatographic film to label pad, on described outer plastic part, offer it and move left and right the outer view window that Shi Buhui stops interior view window.
Further, on described inner working of plastics, offer and be convenient to the adsorptive pads water suction air vent of water suction fast.
Further, be coated with at least one detection line, at least one nature controlling line and an index line in described chromatographic film, be coated with antigen or the antibody of corresponding detection material on described detection line, described index line is sprayed on chromatographic film one end near adsorptive pads.
Further, described sample pad is polyester film, glass or the filter paper with sample filtering function, and described label pad is that antigen or the antibody spraying with label mark forms on label pad medium.
Further, described label pad medium is polyester film, glass, filter paper or nonwoven fabrics, and described label is collaurum, latex, fluorescent grain, quantum dot or up-conversion luminescence material.
Compared with prior art, the utlity model has following beneficial effect: (1) pick-up unit in operating process only shows a well, and well can arrange prompting message, another well of reproducing after reaction one EOS, simple to operate, understand understandable; (2) retained the advantage of two-step approach sufficient reacting, detection sensitivity is high, is not subject to the impact of " HOOK effect "; (3) overcome the shortcoming of existing two-dimensional chromatography method, make the sample that enters reactive system from a side reaction to opposite side, all samples all pass through detection line, having equal opportunities of different detection line contact samples, label having equal opportunities through detection line simultaneously, therefore controlled, the high specificity of sufficient reacting, also has good stability, reproducible feature; (4) being applicable to individual event detects, be particularly useful for multinomial joint-detection, can directly interpretation qualitative detection according to mark difference, also can read instrument and quantitatively detect by detecting, short time is sentence read result fast, even if be of value to the other diagnosis of people's fast bed.
Below in conjunction with the drawings and specific embodiments, the utility model is described in more detail.
Accompanying drawing explanation
Fig. 1 is the diagrammatic cross-section of the utility model embodiment.
Fig. 2 is the view of the utility model embodiment when step (1).
Fig. 3 is the view of the utility model embodiment when step (2).
Fig. 4 is that web joint is at sample pad and the structural representation above label pad.
Fig. 5 is the structural representation of web joint below sample pad and label pad.
Fig. 6 is the structural representation of web joint in the middle of sample pad and label pad.
In figure: 1-chromatographic film, 2-backplanes support thing, 3-adsorptive pads, 4-transition pad, 5-sample pad, 6-label pad, 7-watertight insulation, the inner working of plastics of 8-, 9-outer plastic part, view window in 10-, 11-sample pipetting volume hole, 12-dilution well, the outer view window of 13-, 14-web joint, R-index line mark, C-nature controlling line mark, T1, T2, T3, T4, T5, T6-detection line mark, 1.-step (1), 2.-step (2).
Embodiment
As shown in Fig. 1 ~ 3, a kind of two-step approach immuno-chromatography detection device, comprise chromatographic film 1, backplanes support thing 2, adsorptive pads 3, transition pad 4, sample pad 5, label pad 6, watertight insulation 7, inner working of plastics 8 and outer plastic part 9, described chromatographic film 1 sticks on the backplanes support thing 2 that is positioned at inner working of plastics 8, described adsorptive pads 3 sticks to one end of backplanes support thing 2 and overlaps with chromatographic film 1, described transition pad 4 sticks to the other end of backplanes support thing 2 and overlaps with chromatographic film 1, described sample pad 5 and label pad 6 are arranged on respectively selects one between top in inner working of plastics 8 and the two and transition pad 4 and separates by watertight insulation 7, described outer plastic part 9 is sheathed on outside inner working of plastics 8 with sliding matching mode and exposes arbitrary end of inner working of plastics 8.
In the present embodiment, the length of described watertight insulation 7 can not be cut off label pad 6, sample pad 5 and transition pad 4 simultaneously.Can not cut off simultaneously and refer to and keep right when position initial when watertight insulation 7, can only isolated marks pad 6 and transition pad 4, and sample pad 5 overlaps with transition pad 4; When watertight insulation 7 slides into left while keeping left position, watertight insulation 7 is isolated sample pad 5 and transition pad 4, and label pad 6 overlaps with transition pad 4.Certainly, left and right directions can be exchanged.
In the present embodiment, described outer plastic part 9 links together by certain way with watertight insulation 7, described outer plastic part 9 drives watertight insulation 7 to horizontally slip while horizontally slipping outside inner working of plastics 8, and sample pad 5 and label pad 6 are alternately overlapped by transition pad 4 and chromatographic film 1.
In the present embodiment, on described inner working of plastics 8, offer be convenient to sample pad 5 add sample sample pipetting volume hole 11, be convenient to add the dilution well of dilution and be convenient to observe the interior view window 10 of chromatographic film 1 to label pad 6, on described inner working of plastics 8, can also offer and be convenient to the adsorptive pads 3 water suction air vent of water suction fast; On described outer plastic part 9, offer the outer view window 13 that size is larger than interior view window 10, when it is moved left and right, also can not stop that interior view window 10 observes the result of chromatographic film 1.
In the present embodiment, in described chromatographic film 1, be coated with detection line, nature controlling line and index line.Described detection line comprises but is not limited only to one, on described detection line, be coated with antigen or the antibody (as specific antibody or the progestational hormone antigen of myocardium label Troponin I, MYO, CK-MB) of corresponding detection material, and be longitudinally uniformly distributed to adsorptive pads 3 along transition pad 4, every kind of antigen or antibody spray film width are 1-3 millimeter, between every kind of antigen or antibody, are spaced apart 2-3 millimeter.Described nature controlling line comprises but is not limited only to one (as sheep anti mouse or goat-anti rabbit).Described index line comprises water-soluble dye (as bromcresol purple, Phenol red), and it is sprayed on chromatographic film 1 one end near adsorptive pads 3, is used to indicate the whether enough and sample chromatography reaction time of sample size.
In the present embodiment, described sample pad 5 can adopt different medium as specimen filter, for example there are polyester film, glass or the filter paper etc. of sample filtering function, for filtering erythrocyte, the large particulate matter of sample, use 8964 glasses of buying from Ahlstrom Filtration herein, but be not limited to this.Described label pad 6 is that antigen or the antibody spraying with label mark forms on label pad 6 media, described label pad 6 media can be but be not limited to polyester film, glass, filter paper or nonwoven fabrics, use 6613 polyester films of buying from Ahlstrom Filtration herein, described label is the material that can be used for identification and detect collection signal, for example collaurum, latex or fluorescent grain etc., adopt the antibody that will detect thing of colloid gold label (as myocardium label Troponin I herein, MYO, the special colloidal gold labeled monoclonal antibody of CK-MB or progestational hormone colloidal gold labeled monoclonal antibody) and immune protein IgG(mouse-IgG colloidal gold labeled monoclonal antibody or rabbit-IgG colloidal gold labeled monoclonal antibody of colloid gold label), detecting thing is herein myocardium label Troponin I, MYO, CK-MB or progestational hormone, but be not limited to this.
In the present embodiment, this two-step approach immuno-chromatography detection device can be divided into the assembling of the preparation and determination methods device of test strip.The preparation method of the preparation method that the preparation of this test strip comprises chromatographic film 1 and label pad 6, wherein the preparation method of label pad 6 is sprayed on polyester film after Troponin I, the MYO of colloid gold label, CK-MB antibody-solutions and mouse-IgG colloidal gold labeled monoclonal antibody solution are mixed, and 37 degree are dry was prepared into colloid gold label pad 6 after 6-12 hour; Wherein the preparation method of chromatographic film 1 is evenly sprayed on anti-Troponin I, MYO, CK-MB antibody, sheep anti-mouse antibody and bromcresol purple dyestuff in chromatographic film 1 successively in order, refer in order successively along transition pad 4 to adsorptive pads 3 aspects successively longitudinally spraying be highly that 1 millimeter, width are the strip of 4 millimeters, nature controlling line is positioned near adsorptive pads 3 and 8 millimeters of 1 junctions of chromatographic film place, index line is positioned near adsorptive pads 3 and 3 millimeters of 1 junctions of chromatographic film place, and each line is spaced apart 2-3 millimeter; Chromatographic film 1 after spraying is through the sealing preservation after dry 6-12 hour of 37 degree.
In the present embodiment, the preparation method of this two-step approach immuno-chromatography detection device is as follows: chromatographic film 1 is sticked on backplanes support thing 2, adsorptive pads 3 is sticked to backplanes support thing 2 one end and overlaps and be communicated with chromatographic film 1, transition pad 4 is sticked to backplanes support thing 2 other ends and overlaps and be communicated with chromatographic film 1, sample pad 5 and label pad 6 are fixed on to the sample pipetting volume hole 11 of inner working of plastics 8 upper covers and the lower position of dilution well 12, watertight insulation 7 is fixedly connected with together with outer plastic part 9, outer plastic part 9 is sheathed on to inner working of plastics 8 outsides, and make watertight insulation 7 be positioned at sample pad 5, between label pad 6 and transition pad 4.
In the present embodiment, the using method of this two-step approach immuno-chromatography detection device is as follows: (1) is pushed into inner working of plastics 8 right sides by outer plastic part 9 and flushes, and adds the sample of 80ul in sample pipetting volume hole 11, waits for 2 minutes; (2) observe index line and rinsed and fade by sample, outer plastic part 9 is slided and put in place to inner working of plastics 8 left ends; (3) dilution that adds 100ul is to dilution well observations after 12,10 minutes; (4) if there is red stripes in detection line, illustrate in sample the thing that detects positive, if there is not red stripes, illustrate not contain in sample and detect the concentration that detects thing in thing or sample and detect sensitivity minimization lower than kit, also can carry out concentration determination and realize by quantitative reading apparatus the quantitative detection of kit.
In the present embodiment, the principle of work of this two-step approach immuno-chromatography detection device is as follows: outer plastic part 9 is pushed into inner working of plastics 8 right sides and flushes, add after sample in sample pipetting volume hole 11, sample sucks on transition pad 4 under the effect of sample pad 5, and continue chromatography to chromatographic film 1, and react formation Antibody-antigen complex with the corresponding antibodies in chromatographic film 1; And now watertight insulation 7, in the middle of label pad 6 and transition pad 4, is kept apart transition pad 4 and label pad 6, the solution on transition pad 4 cannot be penetrated in label pad 6; When sample soaks chromatographic film 1, index line can be rinsed and fade, after 2 minutes, reaction completes substantially, and outer plastic part 9 is slided to inner working of plastics 8 left ends, and now outer plastic part 9 shelters from well and reveals dilution well 12.Watertight insulation 7 to adsorptive pads 3 direction side shiftings between sample pad 5 and transition pad 4 and the two is kept apart, links together owing to losing watertight insulation 7 between label pad 6 and transition pad 4 in outside working of plastics 9 moving process simultaneously, when the damping fluid that adds 100ul is to dilution well 12, dilution can dissolve the colloid gold label thing in label pad 6, the label meeting chromatography dissolving is to transition pad 4, and continue chromatography in chromatographic film 1 with Antibody-antigen complex association reaction, form antibody-antigen-labelled antibody double-antibody sandwich and check structure colour developing, nature controlling line antibody response in the mouse-IgG of colloid gold label and chromatographic film 1 colour developing, whether the colour developing of nature controlling line can be used to judge that whether test strip is effective, the colour developing situation of detection line can be used for whether containing thing to be detected in judgement sample, and colour developing intensity and sample in detection substrate concentration be proportionate, can quantitatively detect by corresponding detection reading apparatus.
In the present embodiment, described inner working of plastics 8 is in the sample pipetting volume hole 11 signable step in side (1) and application of sample amounts, described inner working of plastics 8 is in the dilution well 12 signable steps in side (2) and add amount of buffer, described inner working of plastics 8 can annotation step (1) to (2) direction in one end of well opposition side, comprises but is not limited only to use arrow to indicate.For convenient preparation, described sample pad 5 and label pad 6 can also adhere to each other by web joint 14 simultaneously, but can not overlap between the two, as shown in Fig. 4 ~ 6, wherein web joint 14 can be in sample pad 5 with above label pad 6, also can be below, also can be in the centre of sample pad 5 and label pad 6.
The utility model is by the separate design of sample pad 5, adsorptive pads 3, label pad 6 and chromatographic film 1, and tool has the following advantages: (1) has retained the advantage of two-step approach, makes reaction more abundant, and sensitivity is higher.(2) effectively solved the danger that existing chromatography pattern easily adds wrong hole.(3) simultaneously by adding mouth capping after adding sample, effectively stopped the risk polluting.(4) reaction is carried out toward a direction, can fully react, be not subject to the restriction of chromatographic film 1 length, simultaneously after dropping dilution dissolves label, solvent soln is toward equidirectional chromatography, sample on film can be promoted, toward adsorptive pads 3 direction chromatographies, to react more complete, sensitivity is higher.(5) its watertight insulation 7 can effectively be isolated sample pad 5 and transition pad 4, makes to remain in sample in sample pad and does not have influence on label and react with the compound in chromatographic film 1, and quantitative result is more accurate.
The foregoing is only preferred embodiment of the present utility model, all equalizations of doing according to the utility model claim change and modify, and all should belong to covering scope of the present utility model.

Claims (8)

1. a two-step approach immuno-chromatography detection device, it is characterized in that: comprise chromatographic film, backplanes support thing, adsorptive pads, transition pad, sample pad, label pad, watertight insulation, inner working of plastics and outer plastic part, described chromatographic film sticks on the backplanes support thing that is positioned at inner working of plastics, described adsorptive pads sticks to one end of backplanes support thing and overlaps with chromatographic film, described transition pad sticks to the other end of backplanes support thing and overlaps with chromatographic film, described sample pad and label pad are arranged on respectively selects one between top in inner working of plastics and the two and transition pad and separates by watertight insulation, described outer plastic part is sheathed on outside inner working of plastics with sliding matching mode and exposes arbitrary end of inner working of plastics.
2. two-step approach immuno-chromatography detection device according to claim 1, is characterized in that: described watertight insulation is isolated label pad and transition pad initial keeping right when position, and sample pad and transition pad are overlapped; Described watertight insulation slides into left while keeping left position isolates sample pad and transition pad, and label pad and transition pad are overlapped.
3. two-step approach immuno-chromatography detection device according to claim 2, it is characterized in that: described outer plastic part is connected with watertight insulation, described outer plastic part drives watertight insulation to horizontally slip outward in the time that inner working of plastics horizontally slips, and makes sample pad and label pad alternately by transition pad and chromatographic film overlap joint.
4. two-step approach immuno-chromatography detection device according to claim 1, it is characterized in that: on described inner working of plastics, offer be convenient to sample pad add sample sample pipetting volume hole, be convenient to add the dilution well of dilution and be convenient to observe the interior view window of chromatographic film to label pad, on described outer plastic part, offer it and move left and right the outer view window that Shi Buhui stops interior view window.
5. according to the two-step approach immuno-chromatography detection device described in claim 1 or 3, it is characterized in that: on described inner working of plastics, offer and be convenient to the adsorptive pads water suction air vent of water suction fast.
6. two-step approach immuno-chromatography detection device according to claim 1, it is characterized in that: in described chromatographic film, be coated with at least one detection line, at least one nature controlling line and an index line, on described detection line, be coated with antigen or the antibody of corresponding detection material, described index line is sprayed on chromatographic film one end near adsorptive pads.
7. two-step approach immuno-chromatography detection device according to claim 1, it is characterized in that: described sample pad is polyester film, glass or the filter paper with sample filtering function, described label pad is that antigen or the antibody spraying with label mark forms on label pad medium.
8. two-step approach immuno-chromatography detection device according to claim 7, is characterized in that: described label pad medium is polyester film, glass, filter paper or nonwoven fabrics, and described label is collaurum, latex, fluorescent grain, quantum dot or up-conversion luminescence material.
CN201420045235.8U 2014-01-24 2014-01-24 Two-step method immunochromatography testing device Withdrawn - After Issue CN203688562U (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103743900A (en) * 2014-01-24 2014-04-23 厦门为正生物科技有限公司 Immunochromatography detection device and method by adopting two-step method
CN106370871A (en) * 2016-09-23 2017-02-01 武汉百美生物科技有限公司 Test paper for testing chorionic gonadotropin in human saliva and preparation method thereof
CN109187962A (en) * 2017-10-07 2019-01-11 贾晓轻 Blood sample immunochromatography diagnosis test paper, kit and detection method
CN113063938A (en) * 2021-03-13 2021-07-02 河南省农业科学院 High-sensitivity gradient semi-quantitative immunochromatography detection test strip and detection method

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103743900A (en) * 2014-01-24 2014-04-23 厦门为正生物科技有限公司 Immunochromatography detection device and method by adopting two-step method
CN103743900B (en) * 2014-01-24 2015-06-10 厦门为正生物科技有限公司 Immunochromatography detection device and method by adopting two-step method
CN106370871A (en) * 2016-09-23 2017-02-01 武汉百美生物科技有限公司 Test paper for testing chorionic gonadotropin in human saliva and preparation method thereof
CN109187962A (en) * 2017-10-07 2019-01-11 贾晓轻 Blood sample immunochromatography diagnosis test paper, kit and detection method
CN113063938A (en) * 2021-03-13 2021-07-02 河南省农业科学院 High-sensitivity gradient semi-quantitative immunochromatography detection test strip and detection method
CN113063938B (en) * 2021-03-13 2023-09-12 河南省农业科学院 High-sensitivity gradient semi-quantitative immunochromatography detection test strip and detection method

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