The SARS-CoV-2 Antigen Rapid Test Kit uses a fluorescence immunochromatography method to detect SARS-CoV-2 N-antigen. The sample to be tested is applied to the sample well of the test cassette. The test is authorized for sale under CE-IVD in the EU. Tests allow for room temperature storage.
The SARS-CoV-2 N-antigen within the sample forms a complex with an antibody labelled with fluorescently-tagged microspheres. This complex then migrates along the membrane from the sample well to reach the test region (T-line) where it then binds to a second imbedded antibody to the SARS-CoV-2 N-antigen. Any unbound fluorescently-tagged microspheres continue to migrate along the membrane to the control region (C-line) and are bound there by the control region antibody. The test result (T-Line) in the test window is illuminated with a UV lamp of wavelength 365 nm. If both, the T-line and the C-line fluoresce, the test result is SARS-CoV-2 N-anti-gen positive; if only the C-line fluoresces and no T-line becomes visible, the test result is SARS-CoV-2 N-antigen negative. When no C-line becomes visible, the test result is invalid, and the sample must be retested with a new test cassette.
The limit of detection for serum samples is determined at 20 TCID50 /mL and the limit of detection for swab samples was determined at 40 TCID50 /mL.
Cross-reactivity was evaluated by testing a panel of microbials that could potentially cross-react with the SARS-CoV-2 Antigen rapid test in serum and swab samples. The results do not show any cross reactivity.
Sensitivity — Serum: 96.77%, Swab: 97.65%
Specificity — Serum: 98.90%, Swab: 99.60%
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