Immunochromatographic kit for rapidly detecting novel coronavirus N protein as well as preparation method and application of immunochromatographic kit

A technology of coronavirus and immunochromatography, applied in immunoassays, measuring devices, analytical materials, etc., can solve the problems that are not enough to fully meet the needs of epidemic prevention and control, restrict the supply capacity of rapid detection services for new coronaviruses, and accelerate the epidemic Screening of first-line suspected cases, reducing social panic, and simple operation

Pending Publication Date: 2020-07-10
BEIJING ELCOTEQ BIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On January 26, the State Drug Administration approved 4 new coronavirus detection products from 4 companies including BGI, but the currently approved new coronavirus nucleic acid detection reagents are all based on nucleic acid detection methods, and a single sample uses nucleic acid fluorescence. The PCR method takes 3 hours to give the test results, and the nucleic acid sequencing method takes 6 hours to give the test results. More importantly, due to the extremely high requirements of the laboratory environment for gene amplification, the detection throughput is called the biggest constraint factor, which is This greatly restricts the supply capacity of rapid detection services for the new coronavirus, which is not enough to fully meet the needs of epidemic prevention and control

Method used

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  • Immunochromatographic kit for rapidly detecting novel coronavirus N protein as well as preparation method and application of immunochromatographic kit
  • Immunochromatographic kit for rapidly detecting novel coronavirus N protein as well as preparation method and application of immunochromatographic kit
  • Immunochromatographic kit for rapidly detecting novel coronavirus N protein as well as preparation method and application of immunochromatographic kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] 1. Preparation of novel coronavirus N protein immunochromatographic detection kit

[0043] 1) Use fluorescent microspheres to label another strain of mouse anti-new coronavirus N protein monoclonal antibody

[0044] Take 0.5mL fluorescent microspheres, add 1mg carbodiimide (EDC), 1mg N-hydroxysuccinimide (NHS), stir at room temperature, 120r / min for 3h, then add 100μL of another strain of mouse anti-new coronavirus For virus N protein monoclonal antibody, stir for 1 hour at room temperature at a speed of 120 r / min, then add 10 mg of BSA blocking solution, and continue stirring for 1 hour at a speed of 120 r / min. Centrifuge at 12000 r / min for 20 min at 2-8 °C, and remove the supernatant. Finally, the solid precipitate obtained after centrifugation was redissolved to 1 mL with 0.2M phosphate buffer (pH=7.4), and then 1 μL of Proclin300 was added and stored at 4°C until use.

[0045] 2) Using fluorescent microspheres to label rabbit IgG polyclonal antibody

[0046]Take ...

Embodiment 2

[0076] Nasal / oropharyngeal swab sample testing

[0077] The types of samples taken included nasopharyngeal swabs and oropharyngeal swabs.

[0078] After the nasal / oropharyngeal swab samples are collected, they are pre-treated with the sample preservation solution (see Table 3 for the composition). Store in solution and stir. Squeeze the outside of the plastic hose several times with your fingers to fully soak the cotton swab with the sample preservation solution, then pull out the cotton swab, and the liquid that is wrung out (that is, the sample collected on the cotton swab is mixed into the sample preservation solution) is the sample to be tested . Then take 60 μL of the processed sample to be tested and drop it into the sample hole of the test card, let it stand for 15 minutes, and then insert it into the fluorescence immunochromatography analyzer for detection, the instrument automatically calculates the T / C value of the sample, and passes the normal range Judge negativ...

Embodiment 3

[0088] Oral swab / saliva test

[0089] The types of samples taken include oral swabs, saliva.

[0090] After the oral swab / saliva sample is collected, the sample is pre-treated with the sample preservation solution (see Table 5 for the composition). in the liquid and stir. Squeeze the outside of the plastic hose several times with your fingers to fully soak the cotton swab with the sample preservation solution, then pull out the cotton swab, and the liquid that is twisted out (that is, the sample collected on the cotton swab is mixed into the sample preservation solution) is the sample to be tested . Then take 60 μL of the processed sample to be tested and drop it into the sample hole of the test card, let it stand for 15 minutes, and then insert it into the fluorescence immunochromatography analyzer for detection, the instrument automatically calculates the T / C value of the sample, and passes the normal range Judge negative and positive. In addition, when two fluorescent b...

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PUM

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Abstract

The invention relates to an immunochromatographic kit for rapidly detecting novel coronavirus N protein as well as a preparation method and application of the immunochromatographic kit. The immunochromatographic kit comprises a test strip, the test strip comprises a detection line and a quality control line, the detection line is coated with an anti-novel coronavirus N protein antibody, and the quality control line is coated with a goat anti-rabbit polyclonal antibody. The immunochromatographic kit for rapidly detecting the novel coronavirus N protein provided by the invention can be used fordetecting the novel coronavirus N protein in a nasopharynx swab, an oropharynx swab, an alveolar lavage fluid, an oral swab or a saliva sample so as to be used for diagnosing novel coronavirus pneumonia.

Description

technical field [0001] The invention belongs to the field of in vitro diagnosis, in particular to an immunochromatographic kit for rapidly detecting the N protein of novel coronavirus and its preparation method and application. Background technique [0002] The 2019 novel coronavirus (SARS-CoV-2) is a new strain of coronavirus that has never been found in humans before. Common signs of human infection with coronavirus include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure, and even death. On January 26, the State Drug Administration approved 4 new coronavirus detection products from 4 companies including BGI, but the currently approved new coronavirus nucleic acid detection reagents are all based on nucleic acid detection methods, and a single sample uses nucleic acid fluorescence. The PCR method takes 3 hours to give the test results, and the nucl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/569G01N33/558
CPCG01N33/558G01N33/56983G01N33/577G01N2333/165G01N2469/10
Inventor 林斯
Owner BEIJING ELCOTEQ BIO TECH
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