CE Marked Chromatography COVID 19 Saliva Antigen Rapid Test Kit 1Test / Box For Home Use

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

Summary
This product can be used as a supplementary test indicator for suspected cases with negative nucleic
acid test of SARS-Cov-2 or used in conjunction with nucleic acid testing in the diagnosis of suspected cases.
It cannot be used as a basis for the diagnosis and exclusion of pneumonia caused by SARS-Cov-2 infection.

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.