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Novel coronavirus detection reagent strip and novel coronavirus detection kit comprising same

A detection kit and coronavirus technology, applied in the field of novel coronavirus detection kits and novel coronavirus detection reagent strips, can solve problems such as inability to achieve accurate epidemic prevention, low early detection rate of antibody detection reagents, and missed detections.

Pending Publication Date: 2021-04-06
HANGZHOU BAOLIN BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The colloidal gold method is a point-of-care testing (POCT) method, which has the advantages of rapidity, unlimited testing site and low operator requirements. However, the colloidal gold method can only be used for qualitative detection. Compared with quantitative detection methods Poor sensitivity and specificity
[0004] At present, domestic and foreign commercial ELISA, chemiluminescence and colloidal gold method COVID-19 antibody diagnostic products mainly include total antibody and combined detection reagents for IgM and IgG antibodies. However, the sensitivity of each detection method is between 66% and 97.8%. The specificity is between 96.6% and 99.7%. The results show that 2.2% to 34% of patients with new coronary pneumonia are missed, and 0.3% to 3.4% of those tested are misdiagnosed as new coronary pneumonia.
More importantly, the early detection rate of existing commercialized COVID-19 antibody detection reagents is low
In high-endemic areas, existing antibody tests will miss detection and fail to achieve the goal of precise epidemic prevention
In low prevalence populations, existing antibody tests may produce as many or even more false negative results than true positive results, resulting in unnecessary waste of manpower and material resources

Method used

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  • Novel coronavirus detection reagent strip and novel coronavirus detection kit comprising same
  • Novel coronavirus detection reagent strip and novel coronavirus detection kit comprising same
  • Novel coronavirus detection reagent strip and novel coronavirus detection kit comprising same

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] Preparation of novel coronavirus recombinant antigen N protein, S1-RBD protein and S2-ECD protein:

[0082] (1) Using gene cloning technology, PCR amplifies the N gene, S2-ECD gene, and S1-RBD protein encoding the novel coronavirus antigen;

[0083] (2), N gene is transferred into Escherichia coli for expression, S2-ECD gene is transferred into 293 cells for expression, S1-RBD protein is transferred into 293 cells for expression, and new coronavirus recombinant antigen N protein and S2-ECD protein are obtained and S1-RBD protein.

Embodiment 2

[0085] Preparation of chromatographic reaction membrane (two detection lines of IgA and IgG):

[0086] Paste the 25cm wide NC film on the middle area of ​​the PVC bottom card, and then dilute the anti-human IgA, anti-human IgG and goat anti-rabbit IgG antibodies with PBS diluent to 0.2-1mg / ml respectively and draw with a gold sprayer In the corresponding detection line area and quality control line area of ​​the NC membrane. Dry in an oven at 37°C for 12-24 hours, and seal the bag for later use.

Embodiment 3

[0088] Preparation of chromatographic reaction membrane (two detection lines of IgM and IgG):

[0089] Paste the 25cm wide NC film on the middle area of ​​the PVC bottom card, and then dilute the anti-human IgM, anti-human IgG and goat anti-rabbit IgG antibodies with PBS diluent to 0.2-1mg / ml and draw with a gold sprayer In the corresponding detection line area and quality control line area of ​​the NC membrane. Dry in an oven at 37°C for 12-24 hours, and seal the bag for later use.

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Abstract

The invention provides a novel coronavirus detection reagent strip and a novel coronavirus detection kit comprising the same, and relates to the technical field of biological detection. The reagent strip comprises a bottom card, a sample pad, a quantum dot marker combination pad, a chromatography reaction film and water absorbing paper, wherein the specific protein in the quantum dot specific protein compound comprises one of a novel coronavirus N protein, a novel coronavirus S2ECD protein or a novel coronavirus S1-RBD protein. According to the reagent strip, a quantum dot immunochromatography technology is adopted, the novel coronavirus N protein, the novel coronavirus S2-ECD protein and the novel coronavirus S1-RBD protein are used as detection antigens to detect plasma of a novel coronavirus patient to be diagnosed, and the reagent strip has the advantages of being high in sensitivity and specificity and capable of achieving quantitative detection.

Description

technical field [0001] The invention relates to the technical field of biological detection, in particular to a novel coronavirus detection reagent strip and a novel coronavirus detection kit comprising the same. Background technique [0002] Nucleic acid detection and CT imaging are the main methods for screening patients infected with the new coronavirus. The false negative rate of nucleic acid detection is high, the requirements for operators and equipment are high, and the detection time is long. Differential diagnosis of other viral pneumonias by CT examination is difficult, cross-infection is easy, and the operability of health economics is not strong. More importantly, neither of the above two methods can achieve on-site rapid and large-scale screening. At this stage, there is an urgent need to develop rapid detection products with higher sensitivity, stronger reliability, and more convenient operation. [0003] Compared with nucleic acid detection, the detection of...

Claims

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Application Information

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IPC IPC(8): G01N33/569G01N33/58G01N33/558G01N33/543G01N33/68
CPCG01N33/54313G01N33/558G01N33/56983G01N33/588G01N33/6854G01N2333/165G01N2469/20
Inventor 姚航平陈喆陈杭曹少伟陈秋强沈明程吴云
Owner HANGZHOU BAOLIN BIOTECHNOLOGY CO LTD
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