SARS-Cov-2 COVID 19 Rapid Diagnostic Antigen Self Test Kits By Nasal Swab Sample

Intended use

Intended use The product is used for the in vitro qualitative detection of SARS-Cov-2 N-protein antigen in human nasal swab

Summary

Intended use The product is used for the in vitro qualitative detection of SARS-Cov-2 N-protein antigen in human nasal swab

Test principle

Latex Immunochromatography method is used to detect SARS-Cov-2 antigens. After treatment when SARS-Cov-2 antigens in the sample are added to the detection hole, the antigen and latex labeled antibody (monoclonal antibody against SARS-Cov-2) form an immune complex. The complex moves with the liquid to the nitrocellulose membrane, and the detection area of the nitrocellulose membrane is coated with another one. When monoclonal antibody is against SARS-Cov-2 antigen, the immune complex is captured by the antibody on nitrocellulose membrane, forming a red reaction line: the result is positive. When the sample does not contain SARS-Cov-2 antigen or are lower than the minimum detection limit of this kit, no red reaction line appears in the detection area: the result is negative. At the same time, whether the result is positive or negative, as the internal control standard of reagents, a red reaction line will be formed in the quality control area (line C), which is used to judge whether the chromatographic process is normal or not.

Reagents components

The reagent consists of test card, sample preservation solution , dripper and swab. 1. The test card consists of reagent strip and plastic case. The main components of the test strip are: Latex labeled SARS-Cov-2 nucleoprotein monoclonal antibody; SARS-Cov-2 nucleoprotein monoclone antibody coatted in the detection area of nitrocellulose membrane; anti mouse immunoglobulin G polyclonal antibody fixed in the quality control area of nitrocellulose membrane. 2. The main preservation solution was phosphate buffer (PBS, 50mm, ph7.2).