COVID-19 Antigen Test Kit (colloidal gold method) is a rapid, qualitative immunochromatographic assay for the determination of the presence of SARS-CoV-2 antigens in human nasopharyngeal or oropharyngeal swab specimens.When specimens are processed and added to the test card, SARS-CoV-2 antigens present in the specimen bind to antibodies conjugated to detector particles in thetest strip. Then the antigen-antibody complexes migrate toward the membrane by capillary action to the reaction area. The complexes then are captured by anti-SARS-CoV-2 monoclonal antibodies immobilized at the test line region and acolored line appears on the membrane. Test results are interpreted visually at 15-30 minutes based on the presence or absence of visually colored lines. To serveas an internal control, a visible control line will always appear in the control lineregion after proper volume of specimen has been added to indicate a test result is valid.
1. The kit should be stored at 2°C -30°C for the duration of the shelf life.
2. The kit can be stored for up to 12 months if all components are kept on theconditions above.
4. The sample diluent should be covered immediately after use and stored at 2°C-30°C and use it within the validity period.
