CN101266246B - HIV antibody and antigen combined rapid detection reagent kit - Google Patents
HIV antibody and antigen combined rapid detection reagent kit Download PDFInfo
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- CN101266246B CN101266246B CN 200810052962 CN200810052962A CN101266246B CN 101266246 B CN101266246 B CN 101266246B CN 200810052962 CN200810052962 CN 200810052962 CN 200810052962 A CN200810052962 A CN 200810052962A CN 101266246 B CN101266246 B CN 101266246B
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Abstract
The invention relates to biology applied technology field, especially relates to a immune chromatography assay for quickly detecting the human immunologic deficiency disease (HIV) antibody and antigen. The assay comprises two independent test papers A and B and plastic case C for storing the test paper, wherein the test paper A is used for detecting the HIV antibody and the test paper B is used for detecting the HIV p24 antigen. The test paper A and test paper B are parallely encased in the plastic case to constitute the assay. On detecting, the detected sample is added on the sample pad of the test paler and the immunoreaction result is directly observed to perform detection. The assay is used for screening or clinical diagnosis of the HIV infection and at the same time the HIV antigen and antibody are detected, the simpler antibody detection can effectively reduce the window phase for detecting the HIV, with features of quick reaction, easy operation, economy and practicality, suitable for insitu detecting.
Description
Technical field
The present invention relates to the biologic applications technical field, particularly relates to the immune chromatography reagent kit of a kind of HIV antibody and antigen combined fast detecting.
Background technology
Aids (Acquired Immunodeficiency syndrome.AIDS) being called for short acquired immune deficiency syndrome (AIDS), is to infect a kind of serious infectious disease that causes by human immunodeficiency virus (Human immunodeficiency virus, HIV).Since the U.S. diagnosed out the first AIDS patient in 1981, according to up-to-date WHO data assessment, to the end of the year 2007, the whole world was estimated to have 3,300 ten thousand patients infected hivs, and China has patients infected hiv about 700,000.
The route of transmission of AIDS virus mainly comprises blood propagation, property contact, bang and mother-to-baby transmission.Average out to 7～10 years in latent period in human body.HIV infection patient in latent period does not have obvious clinical symptoms, but has the infectiousness of height.HIV is detected to find the infection sources and cuts off propagation by way of being the anti-the most effective means of AIDS processed.The HIV immunology detection is effective and the most widely used method, the HIV Antibody screening be China legal one of four haematogenous examination projects.
The most frequently used reagent of HIV antibody test is HIV antibody ELISA immunoreagent (ELISA) and collaurum class reagent, adopts the third generation HIV antibody diagnosing reagent kit of dual-antigen sandwich method, and sensitivity reaches more than 99%, and specificity is greater than 97%.The shortest infection at HIV can detect the positive in rear more than ten days.But antibody just occurs because part HIV infected at 5-8 month, the World Health Organization (WHO) (WHO) is decided to be 6 months with the window phase that HIV infects.HIV has had infectiousness in window phase, in order further to reduce the generation that window phase infects situation, the 4th generation HIV diagnostic kit has appearred at present in the world, the method that kit has adopted HIV antibody and HIV p24 antigen to detect simultaneously, antibody turns the infection that sun detected HIV in front 4-7 days after infecting than HIV.After HIV infected, what occur the earliest was p24 antigen, the anti-HIV antibody of corresponding specificity then just occurs, dropped to gradually inspection with the rising p24 of antibody titer and did not measure.Can detect again in blood at PD later stage p24 antigen, the detection of P24 antigen is fit to the diagnosis to baby HIV infection in addition.
Up to the present HIV antigen-antibody joint-detection is mainly used in the ELISA kit, and the immunochromatography collaurum class kit that there is no the antigen-antibody joint-detection occurs.Although Xu Keyi etc. have delivered " detecting simultaneously the development of HIV antibody and p24 antigen fast diagnosis reagent " [Xu Keyi, Zhang Yongxin, Wang Ying etc. detect the development of HIV antibody and p24 antigen fast diagnosis reagent simultaneously, China's experiment and clinical virology magazine, 2002,16 (4) 377-279], be not immune chromatography method but adopt, the detection method of practical methods and ELISA is similar, whole testing process is divided into multistep, and surpass 1 hour detection time, does not meet the standard of fast diagnosis reagent.The detection principle of collaurum class reagent is as follows: utilize a kind of antigen of colloid gold label or antibody, at the coated corresponding pairing antigen of the NC of reagent film or antibody, during detection when containing corresponding specific antibody or antigen in the sample, the part formation compound that combines in colloid gold label particle and the sample, then chromatography on the NC film, coated antigen or antibody capture form macroscopic detection (T) line again, by the judgement that realizes the result that has or not of detection line.HIV collaurum para-immunity chromatography fast diagnosis reagent has the advantage that ELISA does not possess: detect fast: namely went out the result in 5-30 minute, and easy and simple to handle, be suitable for Site Detection, the good stability of reagent.
Summary of the invention
The object of the invention provide a kind of easy and simple to handle, quick, be fit to Site Detection, sensitivity and specificity high, be suitable for HIV antibody and antigen combined fast detecting immune chromatography reagent kit that clinical diagnosis or examination are used.Technical scheme is as follows: a kind of human immunodeficiency virus (HIV) antibody and antigen combined rapid detection reagent kit, comprise at the bottom of lid, the box, it is characterized in that in the front, left side of lid 19 two onesize B reaction zone holes 23, A reaction zone hole 24 being set, in B reaction zone hole 23, the right side in A reaction zone hole 24 projection that an arrowhead form respectively is set is that application of sample indicates 22, application of sample indicates 25, indicate 22 at application of sample, the right side of application of sample sign 25 respectively arranges an A well 20, B well 21; 31 left sides arrange two onesize combined support rib D at the bottom of box, 31 right sides arrange two onesize combined support rib C at the bottom of box, pack at the bottom of the box on 31 combined support rib C, the combined support rib D in the position of the loading pad 1 corresponding A well 20 of test paper A9, packed at the bottom of the box on 31 combined support rib C, the combined support rib D in the position of the loading pad 14 corresponding B wells 23 of test paper B10, all projections 27 on the lid 19 insert at the bottom of boxes in the protruding hole 35 on 31, are HIV antibody and antigen combined Quick kit 18;
Also be described test paper A9 comprise loading pad 1 with closely be connected in described loading pad 1 one ends contain the mark Human Immunodeficiency Virus antigen gp41, the collaurum pad 2 of gp36, with the close-connected cellulose nitrate NC of the other end of described collaurum pad 2 film 3 with closely be connected in the suction sample pad 4 of described NC film 3 other ends, described NC film is coated with the detection line 5 that is separated from each other, 6 and nature controlling line 7, described detection line is the HIVgp41 that is coated on the NC film, gp36 antigen, described nature controlling line is the antibody that is coated on the anti-HIV antigen on the NC film, described loading pad 1, collaurum pad 2, NC film 2 and suction sample pad 4 paste and form test paper A9 on the plastic support board 8;
Test paper B and test paper A structure are basic identical, but collaurum pad 15 is anti-HIV p24 antibody, and detection line 13 is anti-HIV p24 antibody, and nature controlling line 12 is dynamics.
The loading pad of kit is glass fibre membrane or nonwoven fabrics, inhales the sample pad and is made of absorbent filter.
The method for coating of kit test paper Staphylococal Protein A is: the solution of respectively gp41, gp36 psma ligand being made 1mg/ml, 0.5mg/ml with 0.01M pH 9.0 carbonate buffer solutions (CBS), rule respectively with the parameter of 1ul/cm in NC film bottom with spray film instrument, coated T1, the T2 line is coated with anti-HIV antibody simultaneously as the C line on NC film top.Test paper B method for coating is: will resist p24 antibody to be mixed with the solution of 1.5mg/ml with 0.01M pH 7.2 phosphate buffers (PBS), with the parameter line with 1ul/cm in NC film bottom of spray film instrument, coated T3 line is coated with mouse IgG antibody simultaneously as the C line on NC film top.After the line with the NC film at drying room, temperature 20-25 ℃, humidity is less than 30%, and is dry 8-10 hour, for subsequent use.
The method for preparing the mark colloid gold particle is: prepare diameter as the colloidal gold solution of 30-50nm take gold chloride-trisodium citrate reduction method, get 100ml collaurum liquid after preparation is finished and be placed in the beaker, use 0.2M K
2CO
3Transfer to pH9.0, add respectively 1mg antigen or antibody by the 100ml colloidal gold solution, stirring at room 1 hour adds 1%BSA, 0.1%PEG 20000, sealing 20min, centrifugal 30 minutes of 12000r/m, abandon supernatant, redissolve to 100ml with the collaurum working fluid, press 1ml solution and spread 22cm
2Ratio be layered on equably on glass fibre membrane or the nonwoven fabrics, put again drying room (temperature 20-25 ℃, humidity is less than 30%) dry 2-4 hour, make the collaurum pad, for subsequent use.
The assembly method of test strips is: in hothouse (temperature 20-25 ℃, humidity is less than 30%), get the plastic support board plate, paste at the middle part that coated NC film is placed on the plastic support board plate, paste at NC film T line one side overlap joint collaurum pad (take collaurum pad 1/3), paste loading pad (take collaurum pad 1/5) at collaurum pad opposite side overlap joint; Inhale sample pad (take inhale sample pad 1/10) at NC film C line one side overlap joint; The difference of test paper A and test paper B is: the collaurum pad mark that test paper A is used be HIV gp41, gp36 antigen, what the NC film was coated is HIV gp41, gp36 antigen, the collaurum pad mark that test paper B uses for anti-HIV p24 antibody, what the NC film was coated is anti-HIV p24 antibody.To post plastic plate with cutter at last and be cut into the wide test strips of 3mm.The parallel plastic casing of packing into test paper B of the test paper A that cuts forms HIV antibody and antigen combined rapid detection reagent kit.
The detection method of kit is: with tested serum or blood plasma balance to the greenhouse, kit is kept flat, on test paper A and test paper B loading pad, add respectively the 50-100ul test sample by well, the sample dissolution collaurum and on the NC film chromatography, then with the naked eye directly observe the appearance situation of C, T line in 30 minutes, and judge testing result.If the T line appears in test paper A, contain anti-HIV antibody in the interpret sample, if the T line appears in test paper B, contain HIV p24 antigen in the interpret sample.If the T line does not occur, the negative or content of interpret sample is lower than the lowest detectable limit of kit.
Human immunodeficiency virus (HIV) antibody and antigen combined Quick kit 18 are by 31 consisting of at the bottom of lid 19, the box, and 31 all is to adopt plastic injection-moulded integrally formedly at the bottom of lid 19, the box, and 31 all is two rectangle box-like body at the bottom of lid 19, the box.
The length of lid 19 is equipped with the length of test paper A9, test paper B10, in the front, left side of lid 19 two onesize slots being set is B reaction zone hole 23, A reaction zone hole 24, in B reaction zone hole 23, the right side in A reaction zone hole 24 projection that an arrowhead form respectively is set is that application of sample indicates 22, application of sample indicates 25, indicate 22 at application of sample, it is A well 20 that the right side of application of sample sign 25 respectively arranges a circular port, B well 21;
Left side, back at lid 19 arranges two onesize B reaction zone holes 23, A reaction zone hole 24 left side edge respectively arrange two onesize projections 28, projection 29, in B reaction zone hole 23, the right side in A reaction zone hole 24 projection that two same lengths vertically respectively are set is rib 26, rib 30, at the edge, back of lid 19 a plurality of projections 27 are set with interval, projection 27 height are higher than the height of projection 28, projection 29.
31 left sides arrange two onesize combined support rib D at the bottom of box, combined support rib D is by the similar " salient rib 36 of [" shape, horizontal at salient rib 36 both sides outward flanges, a salient rib 37 respectively is set to the right, arrange one to the right at salient rib 37 the inside edge one "] respectively be set to the right " salient rib 39 of shape, on salient rib 39 right sides two onesize salient ribs 40 are set respectively vertically; 31 right sides arrange two onesize combined support rib C at the bottom of box, combined support rib C is by the similar " salient rib 32 of [" shape, the height of salient rib 32 is to reduce gradually from left to right formation, two two onesize salient ribs 33 vertically are set in salient rib 32 inboards, individual salient rib 32 right side outward flanges arrange one "] " salient rib 34 of shape, 31 edge arranges a plurality of projections 27 with interval at the bottom of box, projection 27 height are than projection 28, the height of projection 29 wants high edge, back that a plurality of protruding holes 35 are set with interval, in order to be connected with upper projection 27 at lid 19.
Beneficial effect of the present invention is as follows: adopt HIV antibody and antigen combined detection, make present HIV collaurum class diagnostic reagent enter for the 4th generation by the third generation, can improve the recall rate of HIV, shorten the window phase that HIV detects, reach and the similar effect of the 4th generation HIV ELISA diagnostic kit, keep simultaneously colloid gold reagent to be suitable for Site Detection, namely went out the result in 5-30 minute, simple to operate, the characteristics such as the good stability of reagent.
This kit has adopted test paper A and test paper B to pack in the same plastic casing, detects respectively antibody and the antigen of HIV.Although adopted two test paper, only need directly to add test sample when detecting, do not increase step and the complicacy of detection.And adopt two test paper, greatly reduced the complicacy of product development: the detection that test paper A is used for HIV antibody is not used as any change [Li Zhou on the basis of existing technology, three line fast testing plates of human immunodeficiency virus (HIV) 1+2 type antibody, Chinese patent (disclosing) number: CN2501049].Develop separately HIV P24 antigen Test paper and just can realize simultaneously joint-detection to HIV antibody and antigen.And in the ELISA kit, because will be with HIV antigen and antibody sandwich in same ELISA Plate hole, usually cause the obvious decline of the sensitivity of product, need to change technique separately, increased the difficulty that product is made, up to the present, the sensitivity that detects simultaneously the ELISA reagent of HIV antibody and antigen all is lower than the corresponding reagent that detects separately.
Description of drawings:
Fig. 1 test paper A structural representation.
Fig. 2 test paper B structural representation.
Fig. 3 HIV antibody and antigen combined rapid detection reagent kit lid front view.
Fig. 4 HIV antibody and antigen combined rapid detection reagent kit lid rear view.
Vertical view at the bottom of Fig. 5 HIV antibody and the antigen combined rapid detection reagent kit.
The reference numeral explanation:
1: loading pad 2: the collaurum pad
3:NC film 4: inhale the sample pad
5:gp41 detection line 6:gp36 detection line
7: nature controlling line (C) 8: plastic support board
9: test paper A 10: test paper B
11: inhale sample pad 12: nature controlling line (C)
13:P24 detection line (T3) 14: loading pad
15 collaurum pad 16:NC films
17: plastic support board 18: kit
19: lid 20:A well
21:B well 22: application of sample indicates
24:A reaction zone hole, 23:B reaction zone hole
25: application of sample indicates 26: rib
27: projection 28: projection
29: projection 30: rib
31: at the bottom of the box 32: salient rib
33: salient rib 34: salient rib
35: protruding hole 36: salient rib
37: salient rib 38: salient rib
39: salient rib 40: salient rib
C: combined support rib D: combined support rib
Embodiment
The preparation of embodiment 1HIV antibody and antigen combined fast detecting Test paper A9, test paper B10:
1 main material
1.1 recombinant antigen: HIV gp41, gp36: U.S. Biotech Atlantic Inc (BAI.) product is used for being coated with and mark of test paper A; Anti-HIV P24 antibody pairing: BAI company product is used for being coated with and mark of test paper B; Gold chloride: Sigma company product, NC film: Millipore company product; BSA, PEG 20000, caseinhydrolysate: the Sigma product.Other common agents is analytical reagent.1.2HIV antibody National reference (collaurum class): Nat'l Pharmaceutical ﹠ Biological Products Control Institute's inspection development.Comprise 20 parts of positive serums, 20 parts of negative serums, 3 parts of sensitivity serum, 1 part of precision serum.HIV1 P24 antigen National reference comprises and draws together 10 parts of positive serums, 20 parts of negative serums, 10 parts of sensitivity serum, 2 parts of precision serum.
2 methods
2.1HIV the colloid gold label gold chloride-trisodium citrate reduction method of antigen, antibody prepares the colloidal gold solution that diameter is 40nm, gets 3 parts of colloidal gold solutions after preparation is finished, with using respectively 0.2M K
2CO
3Solution is transferred to pH7.0, pH8.0 and pH9.0.Then solution is placed on the magnetic stirring apparatus and slowly stir, slowly be added drop-wise to recombinant antigen or antibody in the colloidal gold solution by the every adding of 100ml solution 0.5mg, 1mg, 1.5mg, continue to stir 1 hour, be added dropwise to again final concentration and be 0.1% PEG2000 and 1% BSA sealing 20min, mark is centrifugal with 12000r/m after finishing, abandon supernatant, precipitation is pressed original volume and is redissolved to collaurum working fluid (the Tris damping fluid of different proportionings, contain BSA, caseinhydrolysate, sucrose and surfactant) in.Then the mark colloidal gold solution is pressed 1ml solution and spread 22cm
2The ratio application of sample on nonwoven fabrics, drying room (temperature 20-25 ℃, humidity is less than 30%) dry 2-4 hour, make the collaurum pad, drying for standby.
2.2HIV being coated among the test paper A of antigen and antibody, respectively gp41, gp36 psma ligand are made the solution of 0.5mg/ml, 1mg/ml, 1.5mg/ml with the CBS of 0.01M pH 9.0, rule respectively with the parameter of 1ul/cm in NC film bottom with spray film instrument, coated T1, the T2 line is coated with anti-HIV antibody simultaneously as the C line on NC film top.Test paper B method for coating is: will resist P24 antibody to be mixed with the solution of 0.5mg/ml, 1mg/ml, 1.5mg/ml with 0.01M pH 7.2PBS, with the parameter line with 1ul/cm in NC film bottom of spray film instrument, coated T3 line is coated with dynamics simultaneously as the C line on NC film top.After the line with the NC film drying room (temperature 20-25 ℃, humidity is less than 30%) dry 8-10 hour, for subsequent use.
2.3HIV fast diagnose test paper bar be assembled in the hothouse (temperature 20-25 ℃, humidity is less than 30%), get the plastic support board plate, paste at the middle part that coated NC film is placed on the plastic support board plate, paste at NC film T line one side overlap joint collaurum pad (take collaurum pad 1/3), paste loading pad (take collaurum pad 1/5) at collaurum pad opposite side overlap joint; Inhale sample pad (take inhale sample pad 1/10) at NC film C line one side overlap joint; The difference of test paper A and test paper B is: the collaurum pad mark that test paper A is used be HIV gp41, gp36 antigen, what the NC film was coated is HIV gp41, gp36 antigen, the collaurum pad mark that test paper B uses for anti-HIV p24 antibody, what the NC film was coated is anti-HIV p24 antibody.Then will post plastic plate with cutter and be cut into the wide test strips of 3mm.The parallel plastic casing of packing into test paper B of the test paper A that cuts forms HIV antibody and antigen combined rapid detection reagent kit.
2.4 detection method with tested serum or blood plasma balance to the greenhouse, the test strips or the kit that prepare are kept flat, during detection, on test paper A and B loading pad, add respectively the 50-100ul test sample, if contain anti-HIV antibody in the sample, P24 antigen, then with sample pad on the collaurum combination of mark, form compound, and be diffused on the NC film further chromatography, when running into the pairing antigen that is coated on T line place on the NC film, during P24 antibody, compound then again and envelope antigen, the combination of P24 antibody is trapped in coated place, when captive colloidal gold composite reaches some, then form macroscopic T line.If the T line appears in test paper A, contain anti-HIV antibody in the interpret sample, if the T line appears in test paper B, contain HIV p24 antigen in the interpret sample.If the T line does not occur, the negative or content of interpret sample is lower than the lowest detectable limit of kit.The C line is as the quality control standard of reagent, and positive and negative sample all can occur when detecting.With the naked eye directly observe the appearance situation of C, T line in 15,20,30 and 45 minutes, and judge testing result.
2.5 after the reagent development sample of reaction system technology assessment method different parameters preparation, take HIV antibody National reference (collaurum class), HIV1 P24 antigen National reference as Quality Control, detect, determine best product reaction system and process route.
3 results
According to the testing result of sample, the optimum mark HIV antigen, antibody pH value of having determined test paper is for being 9.0; The optimum mark amount is the every 100ml colloidal gold solution of 1mg; Best colloid working fluid is 50mM Tris damping fluid, and pH9.0 contains 0.5%BSA, 1% caseinhydrolysate, 2% sucrose and 0.2%Tween20; The coated concentration of best gp 41 Antigens is 1mg/ml, and the antigen coated concentration of gp36 is 0.5mg/ml, and P24 antibody sandwich concentration is 1.5mg/ml.The optimal decision time of testing result is to judge in 5-30 minute.
The performance evaluation of embodiment 2:HIV antibody antigen associating quick diagnosis reagent kit
1 main material
1.1HIV antibody antigen associating quick diagnosis reagent kit: the preparation method sees embodiment one;
1.2HIV antibody, antigen National reference: Nat'l Pharmaceutical ﹠ Biological Products Control Institute's inspection development illustrates and sees embodiment one;
1.3 contain chaff interference serum: comprise respectively 10 parts of common interference object height blood fat, haemolysis, jaundice serum, contain each 10 parts of infectious disease HAV, HBV, HIV, TP and HP Positive Seras, contain each 10 parts of different anti-coagulants heparin, EDTA and sodium citrate blood plasma, collect checking and preservation by our company in the relevant hospital of Efficiency in Buildings in Tianjin Area, above serum or blood plasma detect through two or more ELISA and are HIV antibody and antigen negative serum.
1.4 600 parts of clinical serum HIV positive serums are collected in the relevant hospital of Efficiency in Buildings in Tianjin Area by company, are outpatient service collection check serum, detect through two or more ELISA and are HIV antibody and antigen negative serum.20 parts of HIV positive serums are obtained in relevant AIDS section hospital by company, prove conclusively Positive Sera, deactivation into HIV.
2 methods
2.1 sample detection method: see embodiment one, in 30 minutes, judge testing result.
2.2HIV antibody National reference (collaurum class) detect to take out HIV antibody National reference (collaurum class) serum dish, detects with this test paper after equilibrating to room temperature.
2.3HIV1 National reference serum dish is taken out in the detection of P24 antigen National reference, detects with this test paper after equilibrating to room temperature.
2.4 analyzing the specificity assessment detects the chaff interference sample that contains that company preserves with test paper.
2.5 stability test is preserved this test paper at ambient temperature, takes out the part test paper at 1,3,6,12,18 month, tests with National reference; This test paper is placed under 37 ℃, the 50 ℃ conditions, every 7 days taking-up section test paper, test with National reference.
2.6 the clinical sample assessment is collected clinical serum by enterprise from relevant hospital, detects with this kit, if run into the detection positive, detects with two or more commercial ELISA reagent, with confirmed results again.
3 results
3.1HIV antibody National reference (collaurum class) detects National reference (collaurum class)
The serum dish is tested, and national Specification is passed through in result and expection (table 1) in full accord.
This kit of table 1 is to the test result of HIV antibody National reference (collaurum class)
3.2HIV1P24 antigen National reference test result shows can be by the detection of National reference feminine gender and positive reference material, the P24 antigen detection sensitivity is to 10U/ml (table 2).
This kit of table 2 is to the test result of HIV1P24 National reference
Show that this test paper detects all negative to common interference object height blood fat, haemolysis, jaundice serum 3.3 analyze specificity assessment testing result, all negative to containing infectious disease HAV, HBV, HIV, TP and the detection of HP Positive Sera, detect all negative to containing different anti-coagulants heparin, EDTA and sodium citrate blood plasma.Explanation does not have nonspecific reaction to above material.
3.4 this test paper of stability analysis is preserved at ambient temperature, tests with National reference; 1, detecting in 3,6,12 months all can be by test, as a result there was no significant difference.Accelerating the failure property test under 37 ℃ of conditions detected for 6 weeks altogether, and accelerating the failure property test under 50 ℃ of conditions detected for 3 weeks altogether, all can be by test, and the test paper performance is without remarkable decline.According to the test findings that accelerates the failure, the stability of test paper at ambient temperature should be more than 18 months.
3.5 clinical sample test: detected altogether 600 parts of the clinical samples that enterprise collects, this reagent detects positive 8 parts altogether, recheck negative through ELISA reagent.Specificity=592/600=98.7%.20 parts of positive serum detections are all positive, and sensitivity is=20/20=100
Embodiment 3: preparation HIV antibody and antigen combined Quick kit 18:
Fig. 3 HIV antibody and antigen combined rapid detection reagent kit lid front view.Fig. 4 HIV antibody and antigen combined rapid detection reagent kit lid rear view.Vertical view at the bottom of Fig. 5 HIV antibody and the antigen combined rapid detection reagent kit.Such as Fig. 3, Fig. 4, shown in Figure 5, human immunodeficiency virus (HIV) antibody and antigen combined Quick kit 18 are by 31 consisting of at the bottom of lid 19, the box, 31 all is that employing is plastic injection-moulded integrally formed at the bottom of lid 19, the box, and 31 all is two rectangle box-like body at the bottom of lid 19, the box.
The length of lid 19 is equipped with the length of test paper A9, test paper B10, in the front, left side of lid 19 two onesize slots being set is B reaction zone hole 23, A reaction zone hole 24, in B reaction zone hole 23, the right side in A reaction zone hole 24 projection that an arrowhead form respectively is set is that application of sample indicates 22, application of sample indicates 25, indicate 22 at application of sample, it is A well 20 that the right side of application of sample sign 25 respectively arranges a circular port, B well 21;
Left side, back at lid 19 arranges two onesize B reaction zone holes 23, A reaction zone hole 24 left side edge respectively arrange two onesize projections 28, projection 29, in B reaction zone hole 23, the right side in A reaction zone hole 24 projection that two same lengths vertically respectively are set is rib 26, rib 30, at the edge, back of lid 19 a plurality of projections 27 are set with interval, projection 27 height are higher than the height of projection 28, projection 29.
31 left sides arrange two onesize combined support rib D at the bottom of box, combined support rib D is by the similar " salient rib 36 of [" shape, horizontal at salient rib 36 both sides outward flanges, a salient rib 37 respectively is set to the right, arrange one to the right at salient rib 37 the inside edge one "] respectively be set to the right " salient rib 39 of shape, on salient rib 39 right sides two onesize salient ribs 40 are set respectively vertically; 31 right sides arrange two onesize combined support rib C at the bottom of box, combined support rib C is by the similar " salient rib 32 of [" shape, the height of salient rib 32 is to reduce gradually from left to right formation, two two onesize salient ribs 33 vertically are set in salient rib 32 inboards, individual salient rib 32 right side outward flanges arrange one "] " salient rib 34 of shape, 31 edge arranges a plurality of projections 27 with interval at the bottom of box, projection 27 height are than projection 28, the height of projection 29 wants high edge, back that a plurality of protruding holes 35 are set with interval, in order to be connected with upper projection 27 at lid 19.
The assemble method of kit of the present invention: packed at the bottom of the box on 31 combined support rib C, the combined support rib D in the position of the loading pad 1 corresponding A well 20 of test paper A9, packed at the bottom of the box on 31 combined support rib C, the combined support rib D in the position of the loading pad 14 corresponding B wells 23 of test paper B10, then all projections 27 on the lid 19 are inserted at the bottom of boxes in the protruding hole 35 on 31, be the assembling of finishing HIV antibody and antigen combined Quick kit 18.
Claims (3)
1. human immunodeficiency virus (HIV) antibody and antigen combined rapid detection reagent kit, comprise lid, at the bottom of the box, it is characterized in that front, left side at lid (19) arranges two onesize slots and is respectively B reaction zone hole (23), A reaction zone hole (24), in B reaction zone hole (23), the projection that the right side in A reaction zone hole (24) respectively arranges an arrowhead form is that application of sample indicates (22), application of sample indicates (25), indicate (22) at application of sample, it is A well (20) that the right side of application of sample sign (25) respectively arranges a circular port, B well (21); (31) left side arranges two onesize combined support ribs (D) at the bottom of box, combined support rib (D) comprises similar " first salient rib (36) of [" shape, outward flange is horizontal in the first salient rib (36) both sides, second salient rib (37) respectively is set to the right, at the second salient rib (37) the inside edge one "] is set to the right " the 3rd salient rib (39) of shape, two onesize the 4th salient ribs (40) vertically respectively are set on the 3rd salient rib (39) right side; (31) right side arranges two onesize combined support ribs (C) at the bottom of box, combined support rib (C) comprises the similar " salient rib of [" shape (32), the height of salient rib (32) is to reduce gradually from left to right formation, in salient rib (32) inboard, two onesize salient ribs (33) are set vertically, outward flange arranges one "] on salient rib (32) right side " salient rib (34) of shape, the edge of (31) arranges a plurality of protruding holes (35) with interval at the bottom of box, in order to be connected with upper projection (27) at lid (19);
Pack on the combined support rib (C), combined support rib (D) of (31) at the bottom of the box in the position of loading pad (1) corresponding A well (20) test paper A(9), with test paper B(10) the position of the corresponding B well of loading pad (14) (23) pack on the combined support rib (C), combined support rib (D) of (31) at the bottom of the box, in the protruding hole (35) at the bottom of all projections (27) insertion box on the lid (19) on (31), be HIV antibody and antigen combined detection Quick kit (18);
Test paper A (9) mark and coated be recombinant expressed Human Immunodeficiency Virus antigen gp41, gp36 with antigen, test paper B(10) mark and to be coated with antibody be anti-HIV p24 antibody;
Described test paper A(9) comprise loading pad (1) and closely be connected in described loading pad (1) one end contain the mark Human Immunodeficiency Virus antigen gp41, the collaurum pad (2) of gp36, with the close-connected cellulose nitrate NC of the other end film (3) of described collaurum pad (2) with closely be connected in the suction sample pad (4) of described NC film (3) other end, described NC film is coated with the detection line (5) that is separated from each other, (6) and nature controlling line (7), described detection line is the HIVgp41 that is coated on the NC film, gp36 antigen, described nature controlling line is the antibody that is coated on the anti-HIV antigen on the NC film, described loading pad (1), collaurum pad (2), NC film (3) and suction sample pad (4) paste the upper test paper A(9 that forms of plastic support board (8));
Test paper B (10) and test paper A structure are basic identical, but collaurum pad (15) is anti-HIV p24 antibody, and detection line (13) is the anti-HIV p24 antibody of pairing, and nature controlling line (12) is dynamics;
(31) all are that employing is plastic injection-moulded integrally formed at the bottom of the lid (19) of described kit (18), the box, and (31) all are that elongate in shape and its following middle part that two upper angles are circular shape arranges the square depression that makes progress at the bottom of lid (19), the box;
The length of lid (19), wide, high with test paper A(9), test paper B(10) length, wide, height is equipped with, in the left side, back of lid (19) two onesize slots are set and are respectively B reaction zone hole (23), A reaction zone hole (24), in B reaction zone hole (23), the left side edge in A reaction zone hole (24) respectively arranges two onesize projections (28), projection (29), in B reaction zone hole (23), the right side in A reaction zone hole (24) vertically respectively arranges two same length, wide, high projection is rib (26), rib (30), at the edge, back of lid (19) a plurality of projections (27) are set with interval, projection (27) is high than projection (28), it is high that the height of projection (29) is wanted;
Described loading pad is glass fibre membrane or nonwoven fabrics, inhales the sample pad and is made of absorbent filter.
2. human immunodeficiency virus according to claim 1 (HIV) antibody and antigen combined rapid detection reagent kit is characterized in that: described test paper A(9) mark and coated other specific antigen of HIV chosen wantonly from gp160, gp120, P24 and O hypotype gp41 that also increases with antigen.
3. human immunodeficiency virus according to claim 1 (HIV) antibody and antigen combined rapid detection reagent kit is characterized in that: described test paper A(9) mark and coated other specific antigen of HIV chosen wantonly from gp160, gp120, P24 and O hypotype gp41 that replaces with antigen.
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