Novel 2019 coronavirus antigen detection reagent and preparation method thereof

A coronavirus and antigen detection technology, applied in the field of analysis and detection, can solve the problems that antibody detection cannot be used as a diagnostic indicator alone, cannot exclude infection or explain the infection status, and antibody detection cannot be used alone to diagnose new coronavirus.

Active Publication Date: 2020-08-11
北京倍肯恒业科技发展股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The nucleic acid detection process ranges from 60-120 minutes, and requires professionals to operate in a PCR professional laboratory
Antibody testing cannot be used alone as a diagnostic indicator for screening, but can only be used as an auxiliary diagnostic method when the nucleic acid test is negative
In the FDA's SARS-COV-2 detection guidance, it is clearly stated that antibody detection cannot be used alone for the diagnosis of the new coronavirus, and cannot rule out infection or explain the infection status

Method used

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  • Novel 2019 coronavirus antigen detection reagent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Preparation of reagent strips:

[0065] 1. Solution preparation:

[0066] (1) Microsphere labeling buffer: 50mM MES, pH 6.0

[0067] (2) Microsphere blocking solution: 50mM ethanolamine solution + 0.1-5% BSA

[0068] (3) Microsphere storage solution: 50mM PBS+0.05-0.5%BSA+0.01-0.1%Tween20+0.02%sodium azide

[0069] (4) 10mg / ml NHS

[0070] (5) 10mg / ml EDC

[0071] (6) Glass fiber pretreatment solution: 50Mm borate buffer + 2-10% sucrose + 0.1-0.5% TW20 + 0.1-5% BSA

[0072] (7) Antibody coating solution: 10mM PBS buffer + 1-5% sucrose

[0073] 2. Glass fiber pretreatment

[0074] Soak the glass fiber membrane in the pretreatment solution for 30 minutes, take it out and dry it at room temperature for later use.

[0075] 3. Time-resolved Microsphere Labeling

[0076] 3.1 Prepare fresh EDC and Sulfo-NHS aqueous solutions respectively, with a concentration of 10 mg / mL. EDC and Sulfo-NHS are stored at low temperature and the reagents are susceptible to moisture, so th...

Embodiment 2

[0095] Repeat Example 1, the only difference is that the NC membrane is the NC membrane prepared according to the aforementioned specific method of the present invention.

[0096] After testing, compared with Example 1, when detecting SARS-CoV-2, the time of lateral wicking and absorption of the NC membrane of this example increased by about 22%, and the binding ability of the membrane to N protein increased by about 20%, The sensitivity can be increased by about 2.4 times. This clearly shows that the detection reagent of the present invention has more superior performance.

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Abstract

The invention provides a novel 2019 coronavirus antigen detection reagent and a preparation method thereof. The detection reagent comprises a sample pad, a conjugate pad, an NC membrane and an absorption pad. The product is simple and convenient to operate, short in detection time, high in sensitivity and very suitable for large-scale preliminary screening of primary medical institutions and centralized outbreak areas of epidemic situations.

Description

technical field [0001] The invention relates to the technical field of analysis and detection, in particular to a 2019 novel coronavirus (SARS-CoV-2) antigen detection reagent and a preparation method thereof, more particularly to a reagent for detecting 2019 novel coronavirus antigen by immunofluorescence and its preparation method. Background technique [0002] In the face of the large-scale epidemic of the new crown syndrome (COVID-19), a large number of people need to be screened, diagnosed and treated accordingly. The clinical demand for diagnostic reagents is extremely urgent. [0003] CN105624335B discloses a test kit for genetic detection of Middle East respiratory syndrome coronavirus, which mainly includes RT-PCR reaction solution, primer probe mixture, RT-PCR reaction enzyme system, DEPC H2O and separate and concentrate these reagent bottles or Box for the tube. [0004] CN111020064A discloses a kit for detecting novel coronavirus nucleic acid, the kit includes ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/569G01N33/558G01N33/543
CPCG01N33/54313G01N33/558G01N33/56983G01N33/577G01N2333/165G01N2469/10
Inventor 刘光中姚世平高鲁嘉关苗
Owner 北京倍肯恒业科技发展股份有限公司
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