Swab Rapid Antigen Test Home Kit , IVD Antigen Test Kit Colloidal Gold

Rapid Professional Covid-19 Test Kit/SARS-CoV-2 Antigen Assay Kit by Latex Immunochromatography Method

Intended use

The product is used to detect the SARS-Cov-2 antigen, influenza A virus antigen and influenza B virus antigen in human nasopharyngeal swabs and oropharyngeal swabs.

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. This product can also be used for the auxiliary diagnosis of influenza A virus and influenza B virus infection.

Test principle

Latex Immunochromatography method is used to detect SARS-Cov-2, influenza A or influenza B virus antigens. After treatment when SARS-Cov-2, influenza A or B virus antigens in the sample are added to the detection hole, the antigen and latex labeled antibody (monoclonal antibody against SARS-Cov-2, influenza A or B antigen) 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, influenza A or B 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, influenza A or B antigens 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 (optional), dripper and swab (optional).