The FDA yesterday informed Cellex that it is issuing emergency use authorization (EUA) for the company’s SARS-CoV-2 antibody test for detecting coronavirus.
Cellex (Research Triangle Park, N.C.) is touting its rapid test as the first of its kind to receive authorization amid the coronavirus crisis. It is a lateral flow immunoassay designed for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 (the virus causing COVID-19) in serum, plasma or venipuncture whole blood specimens.
The FDA letter specified that emergency use of the test is limited to authorized laboratories. Results from the test should not be used as the sole basis for diagnosis, according to the agency.
Those results are solely for the detection of the antibodies that are generated as part of the human immune response to the virus. IgM antibodies are detectable in blood several days after the initial infection, while IgG antibodies become detectable later in the process after infection. Positive results for both antibodies could occur after infection and can be indicative of acute or recent infection.
Meanwhile, Bodysphere, which reported that its SARS-CoV-2 rapid test kit was the first to receive an FDA nod earlier this week, issued a clarification statement after it turned out the test has not yet been authorized.
“In the rush to get the desperately needed test kits to the front lines, Bodysphere believed when the manufacturer’s product was listed on the FDA registry website, that was the [FDA] notification the emergency use authorization (EUA) was issued,” wrote Bodysphere CEO Charlton Lui. “This misunderstanding does not in any way invalidate the test kits authenticity or effectiveness. Under the FDA policy, upon the manufacturer receiving its acknowledgment letter from the FDA, Bodysphere being named the distributor on the EUA submission, was authorized to market and distribute test kits to any licensed healthcare practitioner in the United States for diagnostic use while the manufacturer awaits word of a final decision on its FDA EUA application. The manufacturer has performed clinical trials and the information from those trials will be made available to any healthcare provider or government official seeking to validate the effectiveness and authenticity of these tests.”
Bodysphere added at the end of the statement that it is “anxiously waiting” issuance of EUA from the FDA for its two-minute coronavirus antibody test. The Los Angeles-based company said its testing kit showcased a 91% clinical specificity rate and a 99% clinical sensitivity rate.