COVIDBLOCK™ COVID-19 Rapid Test Cassettes Individually Wrapped
The Clarity COVIBLOCK™ COVID-19 Rapid Test Cassettes are 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 COVIBLOCK COVID-19 Rapid Test Cassettes are 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 COVIBLOCK COVID-19 Rapid Test Cassettes is currently under Section IV.D of the FDA?s Policy for Coronavirus Disease-2019 Tests.
- EUA approval through Pathway C of the FDA.
- Combined sensitivity: 93.3%
- Combined specificity 98.8%
- 95% Overall accuracy
- Use whole blood, plasma, or serum
- Fast and easy (with positive results as fast as 10 minutes)
- Room temperature storage
- 20 Tests/Box
- (20) Covid-19 Test Cassettes
- Developer Solution
- Disposable Pipettes
- Package Insert
|Country of Origin||US|
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