WO2023070471A1 - 自测的手持式新型冠状病毒抗原检测卡及试剂盒 - Google Patents

自测的手持式新型冠状病毒抗原检测卡及试剂盒 Download PDF

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Publication number
WO2023070471A1
WO2023070471A1 PCT/CN2021/127189 CN2021127189W WO2023070471A1 WO 2023070471 A1 WO2023070471 A1 WO 2023070471A1 CN 2021127189 W CN2021127189 W CN 2021127189W WO 2023070471 A1 WO2023070471 A1 WO 2023070471A1
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WIPO (PCT)
Prior art keywords
pad
test
sample
section
novel coronavirus
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PCT/CN2021/127189
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English (en)
French (fr)
Inventor
王培�
宁春华
聂晖
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济南百博生物技术股份有限公司
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Priority to PCT/CN2021/127189 priority Critical patent/WO2023070471A1/zh
Priority to CN202111530628.9A priority patent/CN116047064A/zh
Publication of WO2023070471A1 publication Critical patent/WO2023070471A1/zh

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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
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses
    • 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
    • G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • 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
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • 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
    • G01N33/577—Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/08—RNA viruses
    • G01N2333/165—Coronaviridae, e.g. avian infectious bronchitis virus
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the invention relates to the field of in vitro diagnosis, and relates to a self-testing handheld novel coronavirus antigen detection card and a kit.
  • nucleic acid detection is the gold standard for detection of new coronaviruses.
  • nucleic acid detection needs to be tested in a specific environment (laboratory or hospital), but the detection method is complicated, the detection is expensive, it takes hours to complete, and the detection requires Professional personnel and professional equipment, and relatively concentrated testing locations hinder extensive testing. It is not suitable for rapid diagnosis during a full-scale outbreak, and it is not conducive to preventing centralized testing of personnel.
  • a handheld self-test type novel coronavirus antigen detection card includes a test paper and a hand-held terminal arranged on one side of the test paper, and the test paper includes a bottom liner, protective film, and a sample pad, a gold standard pad, a nitrocellulose membrane, and a water-absorbent pad that are sequentially arranged on the bottom liner from the side of the bottom liner away from the hand-held end to the direction of the hand-held end, the The water-absorbing pad includes a continuous first section of water-absorbing pad and a second section of water-absorbing pad, the first section of water-absorbing pad is arranged on the bottom liner, the second section of water-absorbing pad overlaps the nitrocellulose membrane, and the
  • the gold standard pad comprises a continuous first section of the gold standard pad and a second section of the gold standard pad, the first section of the gold standard pad is arranged on the substrate, the second section of the gold standard pad is lapped on the
  • the present application also provides a handheld self-test kit for novel coronavirus resistance, which is used for testing samples to be tested for novel coronavirus resistance, and the handheld self-test kit for novel coronavirus resistance It includes the above-mentioned handheld self-test novel coronavirus antigen test card and sample diluent, the sample diluent is contained in a container, and the handheld self-test novel coronavirus antigen test card and the sample to be tested are placed in Detection is carried out in a container containing the sample diluent.
  • the present application also provides a method for preparing a hand-held self-test novel coronavirus antigen detection card, the preparation method comprising: preparing a gold label coated with a colloidal gold-labeled mouse anti-new coronavirus monoclonal antibody Pad, wherein, making the gold standard pad includes: preparing a colloidal gold solution, including: adding a mouse anti-new coronavirus monoclonal antibody to the obtained colloidal gold solution, the final concentration is 8-18ug/ml, and then adding PEG20000 final concentration Shake on a shaker for 3-5 minutes, let it stand for 15-60 minutes, and add BSA to a final concentration of 0.2-2%.
  • the preparation of the gold-labeled antibody includes: adding a mouse anti-new coronavirus monoclonal antibody to the obtained colloidal gold solution, the final concentration is 8-18ug/ml; adding PEG20000 to a final concentration of 0.2-2%, shaking on a shaker for 3- 5min, let it stand for 15-60min, add BSA to a final concentration of 0.2-2%, centrifuge at high speed to remove the supernatant, add gold standard diluent, the gold standard diluent is phosphate buffer, add A to a final concentration of 0.5%- 2% BS, PEG20000 with a final concentration of 0.5%-2%, and HY-500 with a final concentration of 0.05%-0.5%; and soaking the gold-labeled pad in the gold-labeled antibody for a first preset time, and then Dry with a freeze dryer for a second preset time.
  • the present application also provides a method for detecting the test sample by using the handheld self-testing type novel coronavirus antigen detection card, using the handheld self-testing type novel coronavirus antigen detection card to detect
  • the method for substituting the test sample includes: dropping the sample dilution liquid into the dropper to about 200-500ul; sampling the nasal cavity with a swab to obtain the sample to be tested; after sampling, putting the swab into the dropper to fully release and mix; Insert the test paper into the sample diluent and observe the detection result after a predicted time.
  • the above-mentioned handheld self-test novel coronavirus antigen detection card and kit can be used for home self-test without equipment or professional physicians.
  • the price is low and the requirements for personnel quality are relatively low.
  • Fig. 1 is a handheld self-test novel coronavirus antigen detection card provided by the first embodiment of the present invention.
  • Fig. 2 is the test strip of the handheld self-test novel coronavirus antigen detection card provided by the first embodiment of the present invention.
  • Fig. 3 is a hand-held self-test novel coronavirus antigen kit provided in the first embodiment of the present invention.
  • Fig. 4 is the unit packaging structure of the handheld self-test novel coronavirus antigen kit provided by the embodiment of the present invention.
  • Figure 5 shows the packaging structure of the handheld self-test novel coronavirus antigen kit provided by the embodiment of the present invention.
  • This application provides a self-testing handheld novel coronavirus antigen detection card and its kit.
  • the anterior nasal cavity is used as a sample, which can be used for home self-testing for convenient sampling and high detection sensitivity, and adopts the detection principle of double-antibody sandwich method and colloidal gold Immunochromatography technology is simple to produce, which greatly improves the convenience of detection and reduces costs.
  • a hand-held self-test novel coronavirus antigen detection card 100 provided in the embodiment of the present application includes a test paper 1 and a hand-held terminal 2 arranged on one side of the test paper.
  • the test paper 1 includes a base 11, a protective film 12, and a sample pad 13 arranged sequentially on the base 11 from the side of the base 11 away from the hand-held end 2 toward the direction of the handle 2, Gold standard pad 14, nitrocellulose membrane 15 and absorbent pad 16.
  • the water-absorbing pad 16 includes a continuous first section of water-absorbing pad 161 and a second section of water-absorbing pad 162, the first section of water-absorbing pad 161 is arranged on the bottom liner 11, and the second section of water-absorbing pad 162 is lapped on the The nitrocellulose membrane 15. Wherein, the length of the second section of water-absorbing pad 162 is shorter than the length of the first section of water-absorbing pad 161 .
  • the gold label pad 14 includes a first section of gold label pad 141 and a second section of gold label pad 142 , and the first section of gold label pad 141 is disposed on the substrate 11 .
  • the second section of the gold standard pad 142 overlaps the nitrocellulose membrane 15 .
  • Part of the nitrocellulose membrane 15 is exposed between the second section of the gold standard pad 142 and the second section of the absorbent pad 162 .
  • the exposed part of the nitrocellulose membrane 15 is provided with a detection line T and a quality control line C.
  • the detection line T is coated with a mouse anti-new coronavirus monoclonal antibody.
  • the quality control line C is coated with goat anti-mouse polyclonal antibody.
  • the sample pad 13 includes a continuous first section of sample pad 131 and a second section of sample pad 132, the first section of sample pad 13 is arranged on the bottom liner 11, and the second section of sample pad 132 is lapped on the Describe the gold standard pad 141 in the first paragraph.
  • Described protective film 12 is coated on test paper 1 and is provided with the position of described first section gold standard pad 141 and is positioned between described second section sample pad 132 and described second section gold standard pad 142; Described protective film 12 also Coated on the test paper 1 where the first section of water-absorbing pad 161 is provided, the gold-marked pad 141 is coated with colloidal gold-labeled mouse anti-new coronavirus monoclonal antibody.
  • the sample pad 12 or the gold standard pad 14 is made of glass fiber.
  • the embodiment of the present application provides a hand-held self-test kit 1000 for novel coronavirus resistance, which is used to detect the novel coronavirus resistance of the samples to be tested.
  • the kit 1000 for the handheld self-test novel coronavirus antibody includes a handheld self-test novel coronavirus antigen detection card 100 and a sample diluent 200 , which is contained in a container 300 .
  • the container is a dropper.
  • the handheld self-test novel coronavirus antigen test card 100 and the sample 400 to be tested are placed in the container 300 containing the sample diluent 200 for testing.
  • the sample 400 to be tested is obtained by sampling the anterior nasal cavity with a swab 500 .
  • the kit 1000 can be equipped with a container 300 and a swab 500 .
  • the swab 500 is a nasal swab.
  • the length of the swab is 5-8 cm
  • the diameter of the grip part is 2-3 mm
  • the diameter of the sampling site is 4-7 mm.
  • the swab rod is made of ABS, PP or PE, and the sampling part can be sponge or artificial fiber.
  • the container 300 is made of soft plastic material.
  • the sample diluent 200 includes Tris-HCl, trehalose, PEG20000, Tween-20SDS.
  • the molar concentration of Tris-HCl is 10-100mM
  • the final mass fraction concentration of trehalose is 0.5%-3%
  • the final mass fraction concentration of PEG20000 is 0.5%-3%
  • the final mass fraction concentration of Tween-20 is 0.05%- 1%
  • the final concentration of SDS mass fraction is 0.5%-1%.
  • the diluent 500 is contained in the vacuole.
  • the test paper and the desiccant are placed together in an aluminum foil bag (not shown in the figure), and the package is sealed.
  • the above-mentioned sealed aluminum foil bag, diluent, drop bottle, and anterior nasal cavity swab are placed together in a paper-plastic bag 600 that can be easily torn apart to form a unit structure of the kit, that is to say, the composition of each product in the paper-plastic bag 600 A single-serve novel coronavirus anti-detection product.
  • the paper-plastic bag 600 is composed of medical dialysis paper and plastic paper.
  • the paper-plastic bag 600 is provided with a tear line 601 for easy tearing.
  • the paper-plastic bag 600 is placed in a box 700, and the box is provided with a plurality of partitions 701, and the paper-plastic bag 600 is placed in the box in sequence.
  • the present application also provides a preparation method for the handheld self-test novel coronavirus antigen detection card 100, the preparation method comprising the following steps.
  • Step S1 preparing a gold-labeled pad 14 coated with colloidal gold-labeled mouse anti-new coronavirus monoclonal antibody.
  • Step S1 includes the following steps.
  • Step S11 preparing a colloidal gold solution.
  • the colloidal gold is prepared by reducing trisodium citrate to obtain colloidal gold particles with a particle size of 20-40 nm, and adjusting the pH to 7.5-8.5 with 0.1M K2CO3 solution.
  • the colloidal gold is prepared by reducing trisodium citrate to obtain colloidal gold particles with a particle size of 20-40 nm, and adjusting the pH to 7.5-8.5 with 0.1M K2CO3 solution.
  • Step S12 preparing the gold-labeled antibody, specifically, adding a mouse anti-new coronavirus monoclonal antibody to the obtained colloidal gold solution to a final concentration of 8-18ug/ml, and then adding PEG20000 to a final concentration of 0.2-2%, Shake on a shaker for 3-5 minutes, let stand for 15-60 minutes, and add BSA to a final concentration of 0.2-2%. Centrifuge at high speed to remove supernatant, add gold standard diluent.
  • the gold standard diluent is BSA at a final concentration of 0.5%-2%, PEG20000 at a final concentration of 0.5%-2%, and HY-500 at a final concentration of 0.05%-0.5% in phosphate buffer.
  • a mouse anti-new coronavirus monoclonal antibody is added to the colloidal gold solution, and the final concentration is 15ug/ml; PEG20000 is added to a final concentration of 1%, shaken on a shaker for 3 minutes, allowed to stand for 30 minutes, and then added BSA The final concentration was 1%; the supernatant was removed by quick centrifugation to obtain the gold-labeled antibody stock solution.
  • Step S13 dissolving the gold-labeled antibody stock solution in a pH7.2 phosphate buffer solution
  • the pH7.2 phosphate buffer solution contains 1% BSA mass fraction concentration, 1% PEG20000 mass fraction concentration, HY- The concentration of 500 mass fraction is 0.1%.
  • Step S14 soaking the gold-labeled pad in the gold-labeled antibody for a first preset time, and then drying it with a freeze dryer.
  • the glass fiber gold-labeled pad is soaked in the gold-labeled antibody for 30 minutes, and then dried with a freeze dryer for 3 hours.
  • Step S2 preparing a nitrocellulose membrane 12, specifically, the T line on the nitrocellulose membrane is coated with a mouse anti-new coronavirus monoclonal antibody, and the C line is coated with a goat anti-mouse polyclonal antibody, and the mouse anti-new coronavirus
  • concentration of virus monoclonal antibody is 0.8-1.8mg/ml
  • concentration of goat anti-mouse polyclonal antibody is 1.0-1.8mg/ml.
  • the mouse anti-new coronavirus monoclonal antibody and goat anti-mouse polyclonal antibody all use 0.01M phosphate Buffer (PH7.0-7.4) for dissolution.
  • the C line and T line are scribed with a scriber and then dried in a drying oven.
  • the mouse anti-new coronavirus monoclonal antibody used in the detection line T line was diluted with 0.01M phosphate buffer (PH7.2) to a final concentration of 1.2mg/ml; the goat antibody used in the quality control line
  • the mouse polyclonal antibody was diluted with 0.01M pH7.2 phosphate buffer to a final concentration of 1.0 mg/m; the T-line and C-line were drawn; baked in a 37°C drying oven for 3h.
  • Step S3 preparing the sample pad 16, soaking the sample pad in the sample pad treatment solution for 2 hours before use; adding 2 ml of 0.01M pH7.2 phosphate buffer to the sample pad treatment solution, blocking 0.5ml, Tween-20 0.5 ⁇ l; dry the sample pad with a freeze dryer for 3h.
  • Step S4 preparing test paper 2, cutting the sample pad, gold standard pad, nitrocellulose membrane, water-absorbing pad, and protective film into strips of preset sizes; cutting the cut glass fiber sample pad, glass fiber gold standard pad, nitric acid
  • the cellulose membrane and the water-absorbent pad are pasted on the backing; a part of the water-absorbent pad is overlapped on the upper part of the nitrocellulose membrane and overlapped with the nitrocellulose membrane, and a part of the gold standard pad is overlapped on the upper part of the nitrocellulose membrane and overlapped with the nitrocellulose membrane.
  • the bottom liner is cut in the longitudinal direction and lapped on the bottom liner with sample pads, gold standard pads, nitrocellulose membranes, water-absorbent pads, and protective films to cut the test paper 1 .
  • the above-mentioned dried nitrocellulose membrane, water absorbent pad, glass fiber gold standard pad, and glass fiber sample pad are pasted on the substrate 11 in sequence, and a layer of glass fiber gold standard pad and water absorbent pad is attached.
  • the present application also provides a method for detecting the generation test sample with a handheld self-test type novel coronavirus antigen detection card, and the method for detecting the generation test sample using the handheld self-test type novel coronavirus antigen detection card includes the following step.
  • Step S501 drop the sample dilution liquid into the dropper to about 200-500ul.
  • step S502 a sample to be tested is obtained by sampling the nasal cavity with a swab.
  • Step S503 after sampling, put the swab into the dropper for full release and mixing.
  • Step S504 inserting the test paper into the sample diluent and observing the test result after predicting the time.
  • step S502 the sample to be tested is obtained by sampling the nasal cavity with a swab.
  • step S5021 a sample to be tested is obtained by sampling the nasal cavity with a swab.
  • Step S5022 use the nasal cavity swab to rotate a preset number of turns in the anterior nasal cavity, for example, 4-5 turns.
  • the sample to be tested is formed by rotating the nasal cavity swab for a predetermined number of turns in another anterior nasal cavity. For example, 4-5 laps.

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Abstract

提供了一种手持式自测型新型冠状病毒抗原检测卡，所述手持式自测型新型冠状病毒抗原检测卡包括试纸和设置于所述试纸一侧的手持端，所述试纸包括底衬、保护膜、以及从所述底衬远离所述手持端的一侧往所述手持端方向依序设置于所述底衬的样品垫、金标垫、硝酸纤维素膜和吸水垫，所述硝酸纤维素膜外露部分设有检测线和质控线，所述金标垫包被有胶体金标记的鼠抗新型冠状病毒单克隆抗体，所述检测线包被有鼠抗新型冠状病毒单克隆抗体，所述质控线包被有羊抗鼠多克隆抗体。

Description

自测的手持式新型冠状病毒抗原检测卡及试剂盒 技术领域
本发明涉及体外诊断领域，涉及一种自测的手持式新型冠状病毒抗原检测卡及试剂盒。
 背景技术
控制新型冠状病毒大流行需进行广泛的测试以阻止感染传播。其中国内最广泛使用的方法是进行核酸检测，这是进行新型冠状病毒检测的金标准。尽管它的灵敏度和特异性都较其它检测方法高，但核酸检测需要在特定的环境（实验室或医院）下检测，但检测方法复杂，检测价格昂贵，需要数小时才能完成，而且检测时需要专业的人员和专业设备，检测地点较为集中，阻碍了广泛的检测，不适合疫情全面爆发时的快速诊断，也不利于阻止人员的集中检测。
 技术问题
有鉴于此，实用必要提供一种无需仪器、无需专业医师即可进行家庭自测，价格低廉，对人员素质要求较低的手持式自测型新型冠状病毒抗原检测卡。
 技术解决方案
第一方面，一种手持式自测型新型冠状病毒抗原检测卡，所述手持式自测型新型冠状病毒抗原检测卡包括试纸和设置于所述试纸一侧的手持端，所述试纸包括底衬、保护膜、以及从所述底衬远离所述手持端的一侧往所述手持端方向依序设置于所述底衬的样品垫、金标垫、硝酸纤维素膜和吸水垫，所述吸水垫包括连续的第一段吸水垫和第二段吸水垫，所述第一段吸水垫设置于所述底衬，所述第二段吸水垫搭接于所述硝酸纤维素膜，所述金标垫包括连续的第一段金标垫和第二段金标垫，所述第一段金标垫设置于所述底衬，所述第二段金标垫搭接于所述硝酸纤维素膜，部分所述硝酸纤维素膜从所述第二段金标垫和所述第二段吸水垫之间外露，所述样品垫包括连续的第一段样品垫和第二段样品垫，所述第一段样品垫设置于所述底衬，所述第二段样品垫搭接于所述第一段金标垫，所述保护膜包覆于试纸设有所述第一段金标垫的部位且位于所述第二段样品垫和所述第二段金标垫之间；所述保护膜还包覆于所述试纸设有所述第一段吸水垫的部位，所述硝酸纤维素膜外露部分设有检测线和质控线，所述金标垫包被有胶体金标记的鼠抗新型冠状病毒单克隆抗体，所述检测线包被有鼠抗新型冠状病毒单克隆抗体，所述质控线包被有羊抗鼠多克隆抗体。
第二个方面，本申请还提供一种手持式自测型新型冠状病毒抗的试剂盒，用于对待测样本进行新型冠状病毒抗检测，所述手持式自测型新型冠状病毒抗的试剂盒包括上述手持式自测型新型冠状病毒抗原检测卡、样品稀释液，所述样品稀释液盛放于容器中，所述的手持式自测型新型冠状病毒抗原检测卡、以及待检测样本放置于盛放有所述样品稀释液的容器中进行检测。
第三方面，本申请还提供一种手持式自测型新型冠状病毒抗原检测卡的制备方法，所述制备方法包括：制备包被有胶体金标记的鼠抗新型冠状病毒单克隆抗体的金标垫，其中，制作所述金标垫包括：制备胶体金溶液，包括：在得到的胶体金溶液中加入鼠抗新型冠状病毒单克隆抗体，最终浓度为8-18ug/ml，然后加入PEG20000终浓度为0.2-2%，摇床摇晃3-5min，静置15-60min，加入BSA终浓度为0.2-2%。高速离心去上清，加入金标稀释液。制备所述金标抗体，包括：在得到的胶体金溶液中加入鼠抗新型冠状病毒单克隆抗体，最终浓度为8-18ug/ml；加入PEG20000终浓度为0.2-2%，摇床摇晃3-5min，静置15-60min，加入BSA终浓度为0.2-2%，高速离心去上清，加入金标稀释液，所述金标稀释液为磷酸盐缓冲液中加入A终浓度为0.5%-2%的BS，终浓度为0.5%-2%的PEG20000、终浓度为0.05%-0.5%的HY-500；以及将所述金标垫浸泡在金标抗体中达到第一预设时间，然后用冷冻干燥机干燥第二预设时间。
第四个方面，本申请还提供一种利用所述的手持式自测型新型冠状病毒抗原检测卡检测所述代测试样本的方法，利用所述手持式自测型新型冠状病毒抗原检测卡检测所述代测试样本的方法包括：将样本稀释液滴到滴管内大约200-500ul；用拭子在鼻腔中采样得到待测试样本；采样后将所述拭子放到滴管内充分释放混匀；将所述试纸***到所述样本稀释液中预测时间后观察检测结果。
 有益效果
上述手持式自测型新型冠状病毒抗原检测卡及试剂盒，无需仪器、无需专业医师即可进行家庭自测，价格低廉，对人员素质要求较低。
 附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍。显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图示出的结构获得其他的附图。
图1为本发明第一实施例提供的手持式自测型新型冠状病毒抗原检测卡。
图2为本发明第一实施例提供的手持式自测型新型冠状病毒抗原检测卡的试纸。
图3为本发明第一实施例提供的手持式自测型新型冠状病毒抗原试剂盒。
图4为本发明实施例提供的手持式自测型新型冠状病毒抗原试剂盒单位包装结构。
图5为本发明实施例提供的手持式自测型新型冠状病毒抗原试剂盒包装结构。
本发明目的的实现、功能特点及优点将结合实施例，参照附图做进一步说明。
 本发明的实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
本申请的说明书和权利要求书及上述附图中的术语“第一”、“第二”、“第三”、“第四”等(如果存在)是用于区别类似的对象，而不必用于描述特定的顺序或先后次序。应该理解这样使用的数据在适当情况下可以互换，以便这里描述的实施例能够以除了在这里图示或描述的内容以外的顺序实施。此外，术语“包括”和“具有”以及他们的任何变形，意图在于覆盖不排他的包含，例如，包含了一系列步骤或单元的过程、方法、***、产品或设备不必限于清楚地列出的那些步骤或单元，而是可包括没有清楚地列出的或对于这些过程、方法、产品或设备固有的其它步骤或单元。
需要说明的是，在本发明中涉及“第一”、“第二”等的描述仅用于描述目的，而不能理解为指示或暗示其相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。另外，各个实施例之间的技术方案可以相互结合，但是必须是以本领域普通技术人员能够实现为基础，当技术方案的结合出现相互矛盾或无法实现时应当认为这种技术方案的结合不存在，也不在本发明要求的保护范围之内。
本申请提供了一种自测的手持式新型冠状病毒抗原检测卡及其试剂盒，以前鼻腔为样本，可用于家庭自测采样方便以及检测灵敏度高，且采用双抗夹心法检测原理和胶体金免疫层析技术，生产简单，从而大大提升了检测的便利性并降低成本。
请参看图1和图2，本申请实施例提供的一种手持式自测型新型冠状病毒抗原检测卡100包括试纸1和设置于所述试纸一侧的手持端2。所述试纸1包括底衬11、保护膜12、以及从所述底衬11远离所述手持端2的一侧往所述手持端2方向依序设置于所述底衬11的样品垫13、金标垫14、硝酸纤维素膜15和吸水垫16。
所述吸水垫16包括连续的第一段吸水垫161和第二段吸水垫162，所述第一段吸水垫161设置于所述底衬11，所述第二段吸水垫162搭接于所述硝酸纤维素膜15。其中，所述第二段吸水垫162的长度短于所述第一段吸水垫161的长度。
所述金标垫14包括连续的第一段金标垫141和第二段金标垫142，所述第一段金标垫141设置于所述底衬11。所述第二段金标垫142搭接于所述硝酸纤维素膜15。部分所述硝酸纤维素膜15从所述第二段金标垫142和所述第二段吸水垫162之间外露。所述硝酸纤维素膜15外露部分设有检测线T和质控线C。所述检测线T包被有鼠抗新型冠状病毒单克隆抗体。所述质控线C包被有羊抗鼠多克隆抗体。
所述样品垫13包括连续的第一段样品垫131和第二段样品垫132，所述第一段样品垫13设置于所述底衬11，所述第二段样品132垫搭接于所述第一段金标垫141。
所述保护膜12包覆于试纸1设有所述第一段金标垫141的部位且位于所述第二段样品垫132和所述第二段金标垫142之间；所述保护膜12还包覆于所述试纸1设有所述第一段吸水垫161的部位，所述金标垫141包被有胶体金标记的鼠抗新型冠状病毒单克隆抗体。
其中，所述样品垫12、或者金标垫14由玻璃纤维制成。
请参看图3，本申请实施例提供一种手持式自测型新型冠状病毒抗的试剂盒1000，用于对待测样本进行新型冠状病毒抗检测。所述手持式自测型新型冠状病毒抗的试剂盒1000包括手持式自测型新型冠状病毒抗原检测卡100、样品稀释液200，所述样品稀释液200盛放于容器300中。在本实施例中，容器为滴管。所述的手持式自测型新型冠状病毒抗原检测卡100、以及待测样本400放置于盛放有所述样品稀释液200的容器300中进行检测。在本实施例中，待测样本400为使用拭子500在前鼻腔进行采样而得。在一些可行的实施例中，试剂盒1000可以配备容器300以及拭子500。可以理解地，所述拭子500为采鼻腔拭子。在一些实施例中，拭子长度为5-8cm，握持部分直径为2-3mm，采样部位直径为4-7mm。拭子杆材质为ABS、PP或PE材质，采样部位可以为海绵，亦可以为人造纤维。容器300为软塑料材质。
所述样品稀释液200包括Tris-HCl、海藻糖、PEG20000、吐温-20SDS。其中，所述Tris-HCl摩尔浓度10-100mM，海藻糖质量分数终浓度为0.5%-3%，PEG20000质量分数终浓度为0.5%-3%，吐温-20质量分数终浓度为0.05%-1%，SDS质量分数终浓度为0.5%-1%。所述稀释液500盛放在液泡中。
请参看图4和图5，在本实施例中，试纸和干燥剂共同放置在铝箔袋中（图未示），封口包装。上述封好口的铝箔袋、稀释液、滴瓶、前鼻腔拭子共同放置在方便撕开的纸塑袋600中，形成试剂盒的单元结构，也就是说纸塑袋600中的各产品构成单人份的新型冠状病毒抗检测产品。所述纸塑袋600为医用透析纸和塑料纸组成。所述纸塑袋600设有便于撕裂的撕开线601。所述纸塑袋600放置于盒子700中，所述盒子设有多个隔断701，将所述纸塑袋600依次摆放在盒子中。
本申请还提供一种制备所述的手持式自测型新型冠状病毒抗原检测卡100的制备方法，所述制备方法包括下面步骤。
步骤S1，制备包被有胶体金标记的鼠抗新型冠状病毒单克隆抗体的金标垫14。步骤S1包括下面步骤。
步骤S11，制备胶体金溶液，具体地，胶体金制备方法是采用柠檬酸三钠还原法制备，得到粒径为20-40nm的胶体金颗粒，用0.1M K2CO3溶液调PH至7.5-8.5。例如，在一具体实施例中，称取0.01% AuCl4溶液加入到配液容器中，加热煮沸1min后，加入1.%的质量分数为1%的柠檬酸三钠溶液加热煮沸15min；冷却及定容得到粒径为40nm左右的胶体金颗粒；用0.01M的K2CO3溶液调所述胶体金颗粒的PH值至预期PH值。
步骤S12，制备所述金标抗体，具体地，在得到的胶体金溶液中加入鼠抗新型冠状病毒单克隆抗体，最终浓度为8-18ug/ml，然后加入PEG20000终浓度为0.2-2%，摇床摇晃3-5min，静置15-60min，加入BSA终浓度为0.2-2%。高速离心去上清，加入金标稀释液。金标稀释液为磷酸盐缓冲液中加入终浓度为0.5%-2%的BSA，终浓度为0.5%-2%的PEG20000，终浓度为0.05%-0.5%的HY-500。
例如，在一具体实施例中，在胶体金溶液中加入鼠抗新型冠状病毒单克隆抗体，最终浓度为15ug/ml；加入PEG20000终浓度为1%，摇床摇晃3min，静置30min，加入BSA终浓度为1%；速离心去上清，得到金标抗体原液。
步骤S13，将所述金标抗体原液溶于PH7.2的磷酸盐缓冲液，所述PH7.2的磷酸盐缓冲液含BSA质量分数浓度为1%，PEG20000质量分数浓度为1%，HY-500质量分数浓度为0.1%。
步骤S14，将所述金标垫浸泡在金标抗体中达到第一预设时间，然后用冷冻干燥机干燥。在一个具体实施例中，玻璃纤维金标垫浸泡在金标抗体中30min，然后用冷冻干燥机干燥3h。
步骤S2，制备硝酸纤维素膜12，具体地，硝酸纤维素膜上T线包被有鼠抗新型冠状病毒单克隆抗体，C线包被有羊抗鼠多克隆抗体，所述鼠抗新型冠状病毒单克隆抗体浓度为0.8-1.8mg/ml，羊抗鼠多克隆抗体为1.0-1.8mg/ml，所述鼠抗新型冠状病毒单克隆抗体，羊抗鼠多克隆抗体都用0.01M磷酸盐缓冲液（PH7.0-7.4）进行溶解。所述C线和T线用划线仪进行划线后在干燥箱中烘干。
在一具体实施例中，将检测线T线所用鼠抗新型冠状病毒单克隆抗体用0.01M磷酸盐缓冲液（PH7.2）稀释成终浓度为1.2mg/ml；将质控线所用羊抗鼠多克隆抗体用0.01M的PH7.2磷酸盐缓冲液稀释成终浓度为1.0 mg/m；对T线和C线进行划膜；在37℃干燥箱中烘3h。
步骤S3，制备样品垫16，将所述样品垫在使用前先浸泡在样品垫处理液中2h；在所述样品垫处理液中加入0.01M的PH7.2磷酸盐缓冲液2ml，阻断剂0.5ml，吐温-20 0.5μl；将样品垫用冷冻干燥机进行烘干3h。
步骤S4，制备试纸2，将样品垫、金标垫、硝酸纤维素膜、吸水垫、保护膜裁成预设尺寸的长条；将裁剪后的玻璃纤维样品垫、玻璃纤维金标垫、硝酸纤维素膜、吸水垫贴在底衬；将所述吸水垫一部分搭接在硝酸纤维素膜上部并与硝酸纤维素膜重合，将金标垫一部分搭接在硝酸纤维素膜上部并与硝酸纤维素膜重合，将样品垫的一部分搭接在玻璃纤维金标垫上部并与玻璃纤维金标垫重合，以及将保护膜贴在玻璃纤维金标垫和吸水垫上部；以及用切条机沿着所述长条方向切割底衬以及在底衬上进行搭接样品垫、金标垫、硝酸纤维素膜、吸水垫、保护膜以切割处所述试纸1。在一具体的实施例中，将上述干燥的硝酸纤维素膜、吸水垫、玻璃纤维金标垫、玻璃纤维样品垫依次粘贴在底衬11上，玻璃纤维金标垫和吸水垫上附上一层保护膜，用切条机切成2.5-4.0mm的条形的新型冠状病毒胶体金层析试纸。
本申请还提供一种手持式自测型新型冠状病毒抗原检测卡检测所述代测试样本的方法，利用所述手持式自测型新型冠状病毒抗原检测卡检测所述代测试样本的方法包括下面步骤。
步骤S501，将样本稀释液滴到滴管内大约200-500ul。
步骤S502，用拭子在鼻腔中采样得到待测试样本。
步骤S503，采样后将所述拭子放到滴管内充分释放混匀。
步骤S504，将所述试纸***到所述样本稀释液中预测时间后观察检测结果。
其中，步骤S502,用拭子在鼻腔中采样得到待测试样本。
步骤S5021，用拭子在鼻腔中采样得到待测试样本。
步骤S5022，用采鼻腔拭子在前鼻腔内旋转预设圈数，例如4-5圈。
步骤S5023，用采鼻腔拭子在另一个前鼻腔内旋转预设圈数形成所述待测试样本。例如，4-5圈。
显然，本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘且本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。
以上所列举的仅为本发明较佳实施例而已，当然不能以此来限定本发明之权利范围，因此依本发明权利要求所作的等同变化，仍属于本发明所涵盖的范围。

Claims (14)

  1. 一种手持式自测型新型冠状病毒抗原检测卡，其特征在于，所述手持式自测型新型冠状病毒抗原检测卡包括试纸和设置于所述试纸一侧的手持端，所述试纸包括底衬、保护膜、以及从所述底衬远离所述手持端的一侧往所述手持端方向依序设置于所述底衬的样品垫、金标垫、硝酸纤维素膜和吸水垫，所述吸水垫包括连续的第一段吸水垫和第二段吸水垫，所述第一段吸水垫设置于所述底衬，所述第二段吸水垫搭接于所述硝酸纤维素膜，所述金标垫包括连续的第一段金标垫和第二段金标垫，所述第一段金标垫设置于所述底衬，所述第二段金标垫搭接于所述硝酸纤维素膜，部分所述硝酸纤维素膜从所述第二段金标垫和所述第二段吸水垫之间外露，所述样品垫包括连续的第一段样品垫和第二段样品垫，所述第一段样品垫设置于所述底衬，所述第二段样品垫搭接于所述第一段金标垫，所述保护膜包覆于试纸设有所述第一段金标垫的部位且位于所述第二段样品垫和所述第二段金标垫之间；所述保护膜还包覆于所述试纸设有所述第一段吸水垫的部位，所述硝酸纤维素膜外露部分设有检测线和质控线，所述金标垫包被有胶体金标记的鼠抗新型冠状病毒单克隆抗体，所述检测线包被有鼠抗新型冠状病毒单克隆抗体，所述质控线包被有羊抗鼠多克隆抗体。
  2. 如权利要求1所述的手持式自测型新型冠状病毒抗原检测卡，其特征在于，所述第二段吸水垫的长度小于所述第一段吸水垫，或者所述第二段金标垫小于所述第一段金标垫，或者所述第二段样品垫小于所述第一段样品垫。
  3. 如权利要求1所述的手持式自测型新型冠状病毒抗原检测卡，其特征在于，所述样品垫、或者金标垫由玻璃纤维制成。
  4. 一种手持式自测型新型冠状病毒抗的试剂盒，用于对样本进行新型冠状病毒抗检测，其特征在于，所述手持式自测型新型冠状病毒抗的试剂盒包括如权利要求1~3任一项所述的手持式自测型新型冠状病毒抗原检测卡、样品稀释液，所述样品稀释液盛放于容器中，所述的手持式自测型新型冠状病毒抗原检测卡、以及待检测样本放置于盛放有所述样品稀释液的容器中进行检测。
  5. 如权利要求4所述的手持式自测型新型冠状病毒抗的试剂盒，其特征在于，所述手持式自测型新型冠状病毒抗的试剂盒还包括拭子，所述拭子用于从人体前鼻腔进行取样形成所述待测样本。
  6. 如权利要求4所述的手持式自测型新型冠状病毒抗的试剂盒，其特征在于，所述容器为滴管。
  7. 如权利要求4所述的手持式自测型新型冠状病毒抗的试剂盒，其特征在于，所述样品稀释液包括Tris-HCl、海藻糖、PEG20000、吐温-20SDS,其中，所述Tris-HCl摩尔浓度10-100mM，海藻糖质量分数终浓度为0.5%-3%，PEG20000质量分数终浓度为0.5%-3%，吐温-20质量分数终浓度为0.05%-1%，SDS质量分数终浓度为0.5%-1%。
  8. 如权利要求4所述的手持式自测型新型冠状病毒抗的试剂盒，其特征在于，所述稀释液盛放在液泡中。
  9. 一种如权利要求1~3任意一项所述的手持式自测型新型冠状病毒抗原检测卡的制备方法，其特征在于，所述制备方法包括：制备包被有胶体金标记的鼠抗新型冠状病毒单克隆抗体的金标垫，其中，制作所述金标垫包括：
    制备胶体金溶液，包括：在得到的胶体金溶液中加入鼠抗新型冠状病毒单克隆抗体，最终浓度为8-18ug/ml，然后加入PEG20000终浓度为0.2-2%，摇床摇晃3-5min，静置15-60min，加入BSA终浓度为0.2-2%，高速离心去上清，加入金标稀释液；
    制备所述金标抗体，包括：在得到的胶体金溶液中加入鼠抗新型冠状病毒单克隆抗体，最终浓度为8-18ug/ml；加入PEG20000终浓度为0.2-2%，摇床摇晃3-5min，静置15-60min，加入BSA终浓度为0.2-2%，高速离心去上清，加入金标稀释液，所述金标稀释液为磷酸盐缓冲液中加入A终浓度为0.5%-2%的BS，终浓度为0.5%-2%的PEG20000、终浓度为0.05%-0.5%的HY-500；以及
    将所述金标垫浸泡在金标抗体中达到第一预设时间，然后用冷冻干燥机干燥第二预设时间。
  10. 如权利要求9所述手持式自测型新型冠状病毒抗原检测卡的制备方法，其特征在于，所述手持式自测型新型冠状病毒抗原检测卡的制备方法还包括：硝酸纤维素膜制备方法，所述硝酸纤维素膜制备方法包括：
    硝酸纤维素膜上T线包被有鼠抗新型冠状病毒单克隆抗体，C线包被有羊抗鼠多克隆抗体，所述鼠抗新型冠状病毒单克隆抗体浓度为0.8-1.8mg/ml，羊抗鼠多克隆抗体为1.0-1.8mg/ml，所述鼠抗新型冠状病毒单克隆抗体，羊抗鼠多克隆抗体都用0.01M的PH值为7.0-7.4的磷酸盐缓冲液进行溶解，所述C线和T线用划线仪进行划线后在干燥箱中烘干。
  11. 如权利要求9所述手持式自测型新型冠状病毒抗原检测卡的制备方法，其特征在于，所述手持式自测型新型冠状病毒抗原检测卡的制备方法还包括：样品垫制作方法，所述样品垫制作方法包括：
    在使用前先浸泡在样品垫处理液中，所述样品垫处理液中加入PH值大于7.0小于7.4的0.01M磷酸盐缓冲液1.8-2.7ml，阻断剂0.4-0.6ml，吐温-20 0.4-0.6ml μl；
    样品垫用冷冻干燥机进行烘干3-5h。
  12. 如权利要求9所述手持式自测型新型冠状病毒抗原检测卡的制备方法，其特征在于，所述手持式自测型新型冠状病毒抗原检测卡的制备方法还包括：试纸的制备方法，所述试纸的制备方法包括：
    将样品垫、金标垫、硝酸纤维素膜、吸水垫、保护膜裁成预设尺寸的长条；
    将裁剪后的玻璃纤维样品垫、玻璃纤维金标垫、硝酸纤维素膜、吸水垫贴在底衬；
    将所述吸水垫一部分搭接在硝酸纤维素膜上部并与硝酸纤维素膜重合，将金标垫一部分搭接在硝酸纤维素膜上部并与硝酸纤维素膜重合，将样品垫的一部分搭接在玻璃纤维金标垫上部并与玻璃纤维金标垫重合，以及将保护膜贴在玻璃纤维金标垫和吸水垫上部；以及
    用切条机沿着所述长条方向切割底衬以及在底衬上进行搭接样品垫、金标垫、硝酸纤维素膜、吸水垫、保护膜以切割处所述试纸。
  13. 一种利用所述权利要求1~3任一项所述的手持式自测型新型冠状病毒抗原检测卡检测所述代测试样本的方法，其特征在于，利用所述手持式自测型新型冠状病毒抗原检测卡检测所述代测试样本的方法包括：
    将样本稀释液滴到滴管内大约200-500ul；
    用拭子在鼻腔中采样得到待测试样本；
    采样后将所述拭子放到滴管内充分释放混匀；
    将所述试纸***到所述样本稀释液中预测时间后观察检测结果。
  14. 如权利要求13所述的手持式自测型新型冠状病毒抗原检测卡检测所述代测试样本的方法，其特征在于，用拭子在鼻腔中采样得到待测试样本具体包括：
    用采鼻腔拭子在前鼻腔内旋转预设圈数；以及
    用采鼻腔拭子在另一个前鼻腔内旋转预设圈数形成所述待测试样本。
PCT/CN2021/127189 2021-10-28 2021-10-28 自测的手持式新型冠状病毒抗原检测卡及试剂盒 WO2023070471A1 (zh)

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