NEW YORK – In an update to its page on the impact of SARS-CoV-2 viral mutations on COVID-19 tests, the US Food and Drug Administration said Tuesday that Luminostics' Clip COVID Rapid Antigen Test is likely less effective at identifying SARS-CoV-2 infections involving the BE.1 and BQ.1/BQ1.1 Omicron variants.
The impact "does not appear to be significant," the agency said on its website but published the finding "out of an abundance of caution."
Luminostics gained FDA Emergency Use Authorization in December 2020 for the point-of-care lateral flow assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 using healthcare provider-collected anterior nasal swab specimens that are collected within five days of the onset of symptoms. The FDA said Tuesday that mutations to the nucleocapsid protein E136D — which is associated with the BE.1 and BQ.1/BQ.1.1 Omicron variants — may affect the test's performance.
The test is processed on the Clip Analyzer, an instrument that is built around a modified Apple iPhone SE that uses the smartphone's camera to detect luminescent nanoparticles. It can be used in point-of-care settings or processed by labs that are CLIA-certified to perform high-, moderate-, or waived-complexity tests.
The FDA said it has been collaborating with the National Institutes of Health's Rapid Acceleration of Diagnostics, or RADx, program to study the performance of antigen tests in response to the Omicron SARS-CoV-2 variant, and early data from preliminary studies suggest that antigen tests generally detect infections with the variant but may have reduced sensitivity.
"The FDA, our partners, and test developers continue to evaluate test sensitivity, when tests should be performed, and the frequency of testing," FDA officials said.