Fast and Accurate Results in as little as 3 Minutes
- The Clarity COVID-19 IgG/IgM Antibody Test is an in vitro, rapid, qualitative immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies of COVID-19 in human serum, plasma or whole blood.
- The Clarity COVID-19 IgG/IgM Antibody Test Is currently classified as CLIA Highly Complex and should only be used sold to and used by CLIA Highly complex facilities.
- This test is only provided for use in laboratories or by healthcare workers at the point-of-care.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- Not for the screening of donated blood.
- The Clarity COVID19 IgG/IgM Antibody Test cannot be sold or purchased online.
- The Clarity COVID19 IgG/IgM Antibody Test is currently under Section IV.D of the FDA’s Policy for Coronavirus Disease-2019 Tests.
- Pending EUA approval through Pathway C of the FDA.