In method comparison studies, FTDSARS-CoV-2 has shown 100% (91.8-100, 95% CI) diagnostic sensitivity and 100% (93.8-100, 95% CI) diagnostic specificity when tested in Copan eSwab nasopharyngeal and oropharyngeal swabs.
CE-IVD labelled for diagnostic use in the EU. For research use only (RUO) in the U.S. Pursuing FDA emergency use authorization (EUA) and WHO emergency use listing (EUL).
CE-IVD labelled for diagnostic use in the EU. For research use only (RUO) in the U.S.
Under development. Not available for sale. Future availability cannot be guaranteed.
Product availability varies by country and is subject to local regulatory requirements.