NEW YORK – The US Food and Drug Administration said on Thursday that the performance of Xtrava Health's SARS-CoV-2 antigen test may be affected by certain Omicron subvariants.
The agency said in a notice posted to its website that the Spera COVID-19 Ag Test's performance may be impacted by mutations of the nucleocapsid proteins associated with the BA.1 and BA.2 subvariants. It added that the impact does not appear to be significant, but that the FDA is providing the information "out of an abundance of caution."
The two subvariants were first detected in 2021.
The lateral flow test received Emergency Use Authorization from the FDA in October 2021 for use at the point of care and in laboratories that perform moderate-, CLIA-waived- or high-complexity testing. The firm received funding from the National Institutes of Health's Rapid Acceleration of Diagnostics Tech initiative to develop the test.