We are happy to announce
WE ARE NOW CLIA WAIVED AND POCT APPROVED!
- The Clarity COVIBLOCK COVID-19 Rapid Test Cassettes is an in vitro, rapid, qualitative immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies of COVID-19 in Whole blood ( Fingerstick and Venous) , Plasma or Serum.
- The Clarity COVIBLOCK COVID-19 Rapid Test Cassette used with fingerstick whole blood specimen is currently classified as CLIA Waived, and authorized for use at Point of Care (POC) settings under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
- 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 test 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 COVIBLOCK COVID-19 Rapid Test Cassettes are not OTC approved and cannot be purchased online or used at home.
- The Clarity COVIBLOCK COVID-19 Rapid Test Cassettes CLIA Waiver can be found at: https://www.fda.gov/media/140079/download
- CLIA waived and POCT approved.