Lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2.
Who Can Perform Testing
CLIA-certified laboratories qualified to perform medium or high complexity tests.
Time to Result
- Whole blood
- Plasma from anti-coagulated blood (heparin/EDTA/sodium citrate)
Internal control lines appear when test is ready to be read.
Individually sealed test cassettes in aluminum foil pouch with desiccant. Each cassette contains an IgM strip and an IgG strip, side-by-side. Buffer solution diluent.
Storage & Handling
Cap and store the serum or plasma samples at 2-8°C for no more than 24 hours prior to testing. For long-term storage, freeze the serum or plasma samples at -20°C. Avoid multiple freeze-thaw cycles. Mix thawed samples thoroughly by low speed vortexing or by inverting 10 times. Bring samples to room temperature prior to testing for at least 30 minutes. Visually inspect the samples. If layering or stratification is observed, continue mixing until samples are visibly homogeneous.