Novel coronavirus detection test strip as well as preparation method and application thereof

A coronavirus and detection test strip technology, which is applied in the field of novel coronavirus detection test strips and its preparation, can solve the problems of inability to detect the incubation period and early infection patients, and achieve improved sensitivity and specificity, improved accuracy, and easy operation Effect

Inactive Publication Date: 2020-07-17
北京中检安泰诊断科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, the detection sensitivity and specificity of immunoassay are closely related to the correspondingly prepared antibodies and antigen specificity, and

Method used

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  • Novel coronavirus detection test strip as well as preparation method and application thereof
  • Novel coronavirus detection test strip as well as preparation method and application thereof
  • Novel coronavirus detection test strip as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Example 1 The composition of the novel coronavirus detection test strip

[0052] figure 2 Structural schematic diagram of the novel coronavirus detection test strip provided for the present invention; as figure 2 As shown, the new coronavirus detection test strip includes a PVC base plate 1, and a sample pad 2, a binding pad 3, an analysis membrane 4, and a water-absorbing filter paper 5 are sequentially laid on the PVC base plate 1 along the chromatography direction; the sample pad 2 is partially overlapped on the On the binding pad 3 , the binding pad 3 partially overlaps one side of the analysis membrane 4 , and the absorbent filter paper 5 partially overlaps the other side of the analysis membrane 4 , and the sample pad 2 is provided with a sampling hole 21 .

[0053] Colloidal gold-labeled 2019-nCoV recombinant antigen and colloidal gold-labeled mouse anti-human HCG monoclonal antibody are coated on the binding pad 3; the 2019-nCoV recombinant antigen carries H...

Embodiment 2

[0064] Example 2 The method of using the new coronavirus detection test strip

[0065] Step a. Return the new coronavirus detection test strip, sample diluent and sample to 18-30°C; the sample diluent is phosphate buffered saline, and the sample is serum, plasma or whole blood.

[0066] Step b. Take 10µL serum, plasma or 20µL whole blood sample and add it directly into the sample well;

[0067] Step c, add 100 µL sample diluent to the sample well;

[0068] Step d, interpret the results within 15-20 minutes, and the test results will be invalid after 20 minutes.

[0069] The interpretation of the test results is as follows:

[0070] 1. Positive T1 test line: If the detection window T1 test line and quality control line develop color, it indicates that the sample has detected new coronavirus IgM antibody and / or new coronavirus IgA antibody, which may be in early infection or current infection, and can be combined with Clinical symptoms are finally confirmed to improve the acc...

Embodiment 3

[0075] Example 3 Verification of novel coronavirus detection test strips

[0076] 1. Test strip performance evaluation test

[0077] Serum samples from 30 patients with novel coronavirus pneumonia (COVID-19) were clinically evaluated, and the novel coronavirus (2019-nCoV) IgA, IgM and IgG antibodies were detected by using the novel coronavirus detection test strips of the present invention respectively, and the results in Table 1 below were obtained :

[0078]

[0079] It can be seen from Table 1 that the positive results of IgA and IgM were not completely coincident. There were 15 positive cases of IgA and IgM, 11 cases of IgA antibody positive, 12 cases of IgM antibody positive, and the number of IgA antibody positive and IgM antibody negative. 3 cases, 4 cases were positive for IgM antibody and negative for IgA antibody, 1 case was positive for IgA antibody and negative for IgM antibody and IgG antibody.

[0080] 2019-nCoV IgA antibody detection can increase the detect...

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Abstract

The invention provides a novel coronavirus detection test strip as well as a preparation method and application thereof. The test strip comprises a binding pad and an analysis membrane, and the binding pad is coated with a luminescent substance labeled 2019-nCoV recombinant antigen and a mouse anti-human HCG monoclonal antibody; a T2 detection line, a T1 detection line and a quality control line are sequentially arranged on the analysis membrane along the chromatography direction; the T2 detection line is coated with a mouse anti-human IgG monoclonal antibody, the T1 detection line is coated with a mouse anti-human IgA monoclonal antibody and a mouse anti-human IgM monoclonal antibody, and the quality control line is coated with a goat anti-mouse IgG polyclonal antibody. The test paper card can simultaneously determine the positive conditions of IgA antibody, IgM antibody and IgG antibody in serum of a patient, can more accurately detect the early antibody level condition in the body of the patient, assists in judging different periods of novel coronavirus infection of the patient, and improves the sensitivity and specificity of novel coronavirus detection.

Description

technical field [0001] The invention relates to the technical field of in vitro diagnosis, in particular to a novel coronavirus detection test strip and its preparation method and application. Background technique [0002] Novel coronavirus (2019-nCoV, SARS-CoV-2) is the seventh type of coronavirus isolated from humans. The virus belongs to the genus β, has an envelope, and the particles are round or oval, often pleomorphic, with a diameter of 60-140nm, and its genetic characteristics are significantly different from those of SARS-CoV and MERS-CoV. Current research shows that it has more than 85% homology with bat SARS-like coronavirus (Bat-SL-CoV ZC45). [0003] The basic structure of SARS-CoV-2 is an envelope structure composed of genomic RNA and phosphorylated nucleocapsid protein (N protein), and the envelope structure is chimeric with four proteins: spike glycoprotein (S protein), small envelope glycoprotein (E protein), membrane glycoprotein (M protein) and hemagglut...

Claims

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Application Information

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IPC IPC(8): G01N33/58G01N33/577G01N33/569G01N33/558
CPCG01N33/558G01N33/56983G01N33/577G01N33/587G01N2333/165G01N2469/10
Inventor 伍波赵立春陈超韩露张鑫赵建李根凤刘昊刘涵轩
Owner 北京中检安泰诊断科技有限公司
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