2019 novel coronavirus IgG antibody detection kit
A coronavirus and antibody detection technology, applied in the biological field, can solve the problems of the detection kit sensitivity and specificity need to be improved, and the development cycle is short.
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Embodiment 12019
[0030] Example 1 2019 novel coronavirus IgG antibody detection kit and preparation method thereof
[0031] The 2019 novel coronavirus IgG detection kit includes: novel coronavirus RBD antigen coated on streptavidin magnetic particles, novel coronavirus N antigen coated on streptavidin magnetic particles, acridinium ester labeling mouse anti-human IgG antibody, and 2019 novel coronavirus IgG antibody calibrator.
[0032] In the detection kit, the two antigens coated on the solid phase carrier are obtained by the following methods:
[0033] (1) The novel coronavirus RBD antigen and the novel coronavirus N antigen are biotin-modified respectively to obtain biotinylated novel coronavirus RBD antigen and biotinylated novel coronavirus N antigen;
[0034] (2) Coating the biotinylated novel coronavirus RBD antigen and the biotinylated novel coronavirus N antigen on streptavidin magnetic particles respectively, and obtaining the magnetic particles coated with the novel coronavirus RB...
Embodiment 22019
[0036] Example 2 2019 novel coronavirus IgG antibody detection kit and preparation method thereof
[0037] The 2019 Novel Coronavirus IgG Detection Kit includes: Reagent R1, Reagent R2 and 2019 Novel Coronavirus IgG Antibody Calibrator. Among them, reagent R1 contains novel coronavirus RBD antigen coated on streptavidin magnetic particles and novel coronavirus N antigen coated on streptavidin magnetic particles; reagent R2 contains acridinium ester labeling mouse anti-human IgG antibody; Reagent R1 also includes basic buffer. "Basic buffer" refers to a type of solution with salt balance, pH buffering, protection of active ingredient structure and biological properties. The basic buffer used in this example and the following comparative examples is the same and is a conventional component in the field , including pH regulators, inorganic salt ions, surfactants and stabilizer components.
[0038] The preparation method of the 2019 novel coronavirus IgG antibody detection kit i...
Embodiment 32019
[0064] Example 3 Performance Investigation of 2019 Novel Coronavirus IgG Antibody Detection Kit
[0065] The performance of the kit in Example 2 was inspected, and the detection instrument used was the I3000 automatic chemiluminescence immunoassay analyzer produced by Mike Biological Co., Ltd.
[0066]1. Test kit stability
[0067] The kit prepared in Example 2 was processed in a refrigerator at 2°C-8°C and a water bath at 37°C respectively, and the thermal stability of the kit was tested with a negative calibrator and a positive calibrator. The test results are shown in Table 1.
[0068] Table 1
[0069] Negative calibrator (RLU) Positive calibrator (RLU) Store the kit at 2°C-8°C 73 20482 Store the kit at 37°C for 7 days 57 15577 signal retention 78.1% 76.1%
[0070] It can be seen from Table 1 that the 2019 Novel Coronavirus IgG Antibody Detection Kit was treated in a 37°C water bath for 7 days (simulating 2°C-8°C storage for 1 year), ...
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