Financial and Business Media
CE-marked for sale in the EU. This test has not been reviewed by the FDA. In the US, use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. Product availability may vary by country and is subject to regulatory requirements.
≥ 14 days post-PCR positive test
Product claims, including intended use, are applicable to the CE-marked assay. These claims have not been authorized by FDA.
Dependent upon test mix.
Under development. Not available for sale. Future availability cannot be guaranteed.
CE-marked for sale in the EU. This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary by country and is subject to regulatory requirements.
In method comparison studies, FTD SARS-CoV-2 has shown Positive Percent Agreement: 100% (91.8-100, 95% CI) and Negative Percent Agreement: 100% (88.7-100, 95% CI) when tested in Copan eSwab nasopharyngeal and oropharyngeal swabs.
CE-marked for sale in the EU. Research Use Only (RUO) in the U.S.