WO2022141776A1 - Bandelette réactive de détection et kit pour le nouveau coronavirus - Google Patents

Bandelette réactive de détection et kit pour le nouveau coronavirus Download PDF

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Publication number
WO2022141776A1
WO2022141776A1 PCT/CN2021/076965 CN2021076965W WO2022141776A1 WO 2022141776 A1 WO2022141776 A1 WO 2022141776A1 CN 2021076965 W CN2021076965 W CN 2021076965W WO 2022141776 A1 WO2022141776 A1 WO 2022141776A1
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WO
WIPO (PCT)
Prior art keywords
novel coronavirus
test strip
pad
antibody
detection
Prior art date
Application number
PCT/CN2021/076965
Other languages
English (en)
Chinese (zh)
Inventor
张二盈
齐芳
Original Assignee
深圳市金准生物医学工程有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Application filed by 深圳市金准生物医学工程有限公司 filed Critical 深圳市金准生物医学工程有限公司
Publication of WO2022141776A1 publication Critical patent/WO2022141776A1/fr

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Classifications

    • 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
    • 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
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids

Definitions

  • the present application relates to biomedical detection tools, and more particularly to a novel coronavirus detection test strip and kit.
  • Coronavirus is a large family of viruses known to cause colds and severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The strain was first discovered in 2019, so it is called a new type of coronavirus (2019-nCOV).
  • MERS Middle East Respiratory Syndrome
  • SARS Severe Acute Respiratory Syndrome
  • coronavirus Common signs of human infection with coronavirus include respiratory symptoms, fever, cough, shortness of breath, and difficulty breathing. In more severe cases, infection can lead to pneumonia, severe acute respiratory syndrome, renal failure, and even death. There is no specific treatment for the disease caused by the new coronavirus.
  • the main transmission route of the new coronavirus (2019-nCOV) is respiratory droplet transmission and contact transmission. It has high contagious characteristics and some infected people have no symptoms of infection after infection. The incubation period can be as high as 3-14 days or even longer, with high concealment. Therefore, the detection of early new crown infections is particularly important for epidemic prevention and control.
  • nucleic acid diagnosis mainly relies on polymer chain reaction (PCR) or nucleic acid sequencing methods, but nucleic acid diagnosis requires a professional laboratory (in line with PCR testing laboratory), which requires high professional level of personnel, and the operation is complicated, which takes several hours
  • PCR polymer chain reaction
  • nucleic acid diagnosis requires a professional laboratory (in line with PCR testing laboratory), which requires high professional level of personnel, and the operation is complicated, which takes several hours
  • the detection process is very easy to generate aerosols, which can easily lead to false positive results. If the sampling is not qualified, false negative results will be caused, which is difficult for large-scale screening.
  • the marker is colloidal gold, with low sensitivity
  • the technical problem to be solved by this application is to provide a novel coronavirus detection test strip and kit that are convenient for simultaneous detection of IgG and IgM antibodies and have higher sensitivity.
  • a novel coronavirus detection test strip which includes a backboard, and the backboard is attached end to end with a water absorbing pad, a nitrocellulose membrane, a combination of A pad and a sample pad, wherein the binding pad is sprayed with a novel coronavirus protein labeled with quantum dots, and the nitrocellulose membrane is provided with an M detection line coated with an anti-human IgM antibody, and a G coated with an anti-human IgG antibody. Test line and quality control line coated with goat anti-mouse IgG antibody.
  • the quantum dots are quantum dot monomers or quantum dot microspheres.
  • the particle size of the quantum dots is 80-300 nm.
  • a further technical solution thereof is: the M detection line, the G detection line and the quality control line are arranged in parallel and spaced in sequence along the direction from the binding pad to the water absorbing pad.
  • a further technical solution thereof is: the G detection line, the M detection line and the quality control line are arranged in parallel and spaced in sequence along the direction from the binding pad to the water absorbing pad.
  • the novel coronavirus protein includes one or more of N protein, S protein and RBD protein.
  • the anti-human IgG antibody includes goat anti-human IgG polyclonal antibody, mouse anti-human IgG monoclonal antibody, rabbit anti-human IgG polyclonal antibody or rabbit anti-human IgG monoclonal antibody.
  • the anti-human IgM antibody includes goat anti-human IgM polyclonal antibody, mouse anti-human IgM monoclonal antibody, rabbit anti-human IgM polyclonal antibody or rabbit anti-human IgM monoclonal antibody.
  • the back plate is a PVC plate.
  • a novel coronavirus detection kit which includes a jam and a test strip located in the jam, and the test strip is the above-mentioned test strip, and the A sample adding hole is opened on the cartridge corresponding to the sample pad, and a sample is added to the sample pad through the sample adding hole.
  • the novel coronavirus detection test strip of the present application uses quantum dots to mark the novel coronavirus protein, which can identify trace antibodies, and has the characteristics of high sensitivity, strong stability, and strong anti-interference.
  • the nitrocellulose membrane of the paper strip is equipped with an M detection line coated with anti-human IgM antibody and a G detection line coated with anti-human IgG antibody, so that IgG and IgM antibodies can be detected at the same time by adding a sample, which is convenient for early diagnosis. Whether you are infected with the new coronavirus is conducive to the prevention and treatment of the new coronavirus.
  • FIG. 1 is a schematic structural diagram of a specific embodiment of the novel coronavirus detection test strip of the present application.
  • FIG. 2 is a schematic structural diagram of a specific embodiment of the novel coronavirus detection kit of the present application.
  • FIG. 1 is a schematic structural diagram of a specific embodiment of the novel coronavirus detection test strip 10 of the present application.
  • the test strip 10 includes a backboard 1 , on which a water absorbing pad 5 , a nitrocellulose membrane 4 , a binding pad 3 and a sample pad are attached end to end in sequence. 2, wherein, the novel coronavirus protein marked by quantum dots is sprayed on the binding pad 3, and the nitrocellulose membrane 4 is provided with an M detection line 43 coated with an anti-human IgM antibody, and an anti-human IgG antibody coated M detection line 43. G detection line 42 and control line 41 coated with goat anti-mouse IgG antibody.
  • the quantum dots are quantum dot monomers or quantum dot microspheres, and the particle size of the quantum dots is preferably 80-300 nm.
  • quantum dots are used to mark the novel coronavirus protein, which can recognize trace antibodies, and has the characteristics of high sensitivity, strong stability, and strong anti-interference.
  • IgM antibody is rapidly produced, maintained for a short time, and disappears quickly, so IgM antibody can be used as an early infection indicator , and IgG antibodies are produced late, last for a long time and disappear slowly.
  • IgG antibodies can be used as an indicator of infection and previous infection. Using the test strip of this application, IgG and IgM antibodies can be simultaneously detected by adding a sample at 10 o'clock, which is simple and convenient. Diagnosing whether you are infected with the new coronavirus is beneficial to the prevention, control and treatment of the new coronavirus.
  • the M detection line 43 , the G detection line 42 and the quality control line 41 are arranged in parallel and at intervals along the direction from the bonding pad 3 to the absorbent pad 5 , that is, in this embodiment, the coating
  • the G detection line 42 of the anti-human IgG antibody is close to the quality control line 41. It is understood that, in some other embodiments, the M detection line 43 coated with the anti-human IgM antibody, that is, G, may also be close to the quality control line 41.
  • the detection line 42 , the M detection line 43 and the quality control line 41 can also be arranged in parallel and spaced in sequence along the direction from the binding pad 3 to the water absorbing pad 5 .
  • the novel coronavirus protein includes one or more of N protein, S protein, and RBD protein;
  • the anti-human IgG antibody includes goat anti-human IgG polyclonal antibody, mouse anti-human IgG monoclonal antibody Clonal antibody, rabbit anti-human IgG polyclonal antibody or rabbit anti-human IgG monoclonal antibody;
  • the anti-human IgM antibody includes goat anti-human IgM polyclonal antibody, mouse anti-human IgM monoclonal antibody, rabbit anti-human IgM polyclonal antibody or Rabbit anti-human IgM monoclonal antibody.
  • the novel coronavirus protein includes 1:1 N protein and RBD protein
  • the anti-human IgG antibody includes mouse anti-human IgM monoclonal antibody
  • the anti-human IgM antibody includes mouse anti-human IgM antibody Human IgM monoclonal antibody.
  • the back plate 1 is a PVC fluorescent plate, and the distance between adjacent two of the M detection line 43 , the G detection line 42 and the quality control line 41 is 2mm-7mm.
  • FIG. 2 is a schematic structural diagram of a specific embodiment of the novel coronavirus detection kit 100 of the present application.
  • the kit 100 includes a cartridge 20 and a test strip 10 located in the cartridge 20, the test strip 10 is the test strip described in the above embodiment, and the cartridge 20 A sample adding hole 201 is opened on the top corresponding to the sample pad 2 , and a sample is added to the sample pad 2 through the sample adding hole 201 .
  • the kit 100 of the present application When using the kit 100 of the present application, first take 10ul of peripheral blood, whole blood, serum or plasma sample, add the sample to the sample pad 2 through the sample addition hole 201, and then drop 2 drops of the diluent into the sample addition hole 201. , 15 minutes later, the IgG/IgM value was detected to diagnose whether it was infected with the new coronavirus.
  • the novel coronavirus detection test strip of the present application uses quantum dots to mark the novel coronavirus protein, which can identify trace antibodies, has the characteristics of high sensitivity, strong stability, strong anti-interference, etc., and is in the same test strip.
  • the new coronavirus is conducive to the prevention, control and treatment of the new coronavirus.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Pathology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Peptides Or Proteins (AREA)

Abstract

L'invention concerne une bandelette réactive de détection pour le nouveau coronavirus, comprenant une plaque arrière, un tampon d'absorption d'eau, une membrane de nitrocellulose, un tampon de liaison et un tampon d'échantillon étant raccordés séquentiellement bout à bout sur la plaque arrière ; une nouvelle protéine de coronavirus marquée par des points quantiques étant pulvérisée sur le tampon de liaison ; et une ligne de détection M revêtue d'anticorps anti-IgM humaines, une ligne de détection G revêtue d'anticorps anti-IgG humaines, et une ligne de contrôle de qualité revêtue d'anticorps de chèvre anti-IgG de souris étant définies sur la membrane de nitrocellulose. Les points quantiques sont utilisés pour marquer les nouvelles protéines de coronavirus, et peuvent identifier des anticorps à l'état de trace, présentent des caractéristiques telles qu'une sensibilité élevée, une forte stabilité, une forte anti-interférence et équivalents, et une ligne de détection M revêtue d'anticorps anti-IgM humaines et une ligne de détection G revêtue d'anticorps anti-IgG humaines sont définies sur la membrane de nitrocellulose de la même bandelette réactive, de telle sorte que les anticorps IgG et IgM peuvent être détectés en même temps au moyen d'une charge d'échantillon unique, ce qui facilite le diagnostic précoce d'infection ou non par le nouveau coronavirus chez un individu. L'invention concerne également un kit.
PCT/CN2021/076965 2020-12-30 2021-02-20 Bandelette réactive de détection et kit pour le nouveau coronavirus WO2022141776A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202023288163.4 2020-12-30
CN202023288163 2020-12-30

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WO2022141776A1 true WO2022141776A1 (fr) 2022-07-07

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2023142A1 (fr) * 2007-07-30 2009-02-11 Mikrogen Molekularbiologische Entwicklungs-GmbH Dosage immunologique utilisant des protéines de capsides nucléiques recombinantes pour la détection d'anticorps aux coronavirus humains
CN111190005A (zh) * 2020-02-23 2020-05-22 重庆新赛亚生物科技有限公司 新型冠状病毒抗体检测用检测试剂卡及其制备方法
CN111426840A (zh) * 2020-06-11 2020-07-17 北京中检安泰诊断科技有限公司 一种新型冠状病毒检测试纸条及其制备方法和应用
CN111426829A (zh) * 2020-03-13 2020-07-17 南京农业大学 一种检测SARS-CoV-2 IgM-IgG抗体总量的量子点微球免疫层析试纸条
CN111426844A (zh) * 2020-03-13 2020-07-17 南京农业大学 一种新型冠状病毒SARS-CoV-2 IgG-IgM抗体联检的荧光免疫层析试纸条
CN111474354A (zh) * 2020-06-02 2020-07-31 益善生物技术股份有限公司 2019-nCoV新型冠状病毒检测层析试纸条、检测卡和试剂盒

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2023142A1 (fr) * 2007-07-30 2009-02-11 Mikrogen Molekularbiologische Entwicklungs-GmbH Dosage immunologique utilisant des protéines de capsides nucléiques recombinantes pour la détection d'anticorps aux coronavirus humains
CN111190005A (zh) * 2020-02-23 2020-05-22 重庆新赛亚生物科技有限公司 新型冠状病毒抗体检测用检测试剂卡及其制备方法
CN111426829A (zh) * 2020-03-13 2020-07-17 南京农业大学 一种检测SARS-CoV-2 IgM-IgG抗体总量的量子点微球免疫层析试纸条
CN111426844A (zh) * 2020-03-13 2020-07-17 南京农业大学 一种新型冠状病毒SARS-CoV-2 IgG-IgM抗体联检的荧光免疫层析试纸条
CN111474354A (zh) * 2020-06-02 2020-07-31 益善生物技术股份有限公司 2019-nCoV新型冠状病毒检测层析试纸条、检测卡和试剂盒
CN111426840A (zh) * 2020-06-11 2020-07-17 北京中检安泰诊断科技有限公司 一种新型冠状病毒检测试纸条及其制备方法和应用

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HUANG PEI, ET AL.: "Development of a Quantum Dot-Based Immunochromatographic Strip for Detection of Middle East Respiratory Syndrome Coronavirus", ZHONGGUO BINGYUAN SHENGWUXUE ZAZHI - JOURNAL OF PATHOGEN BIOLOGY, SHANDONG-SHENG JISHENGCHONGBING FANGZHI YANJIUSUO, CN, vol. 13, no. 6, 30 June 2018 (2018-06-30), CN , pages 557 - 561, XP055948181, ISSN: 1673-5234, DOI: 10.13350/j.cjpb.180601 *

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