NEW YORK – The US Food and Drug Administration on Friday granted Emergency Use Authorization for Quidel's Sofia 2 SARS Antigen FIA, a rapid point-of-care test for the detection of the novel coronavirus.
The test is the first protein-based antigen test to receive EUA from the FDA and is for the qualitative detection of a nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal and nasal swab specimens. Tests that previously received FDA EUAs are either molecular, detecting viral nucleic acid, or serology tests that detect antibodies to the coronavirus.
Rapid antigen tests can be a new strategy in the fight against COVID-19. Compared to PCR tests, which can take about a day for results, Quidel's antigen test provides results in about 15 minutes. Historically, though, antigen tests for flus and other ailments have not been as accurate as molecular tests.
In its instructions for use for the Sofia 2 SARS Antigen FIA test, Quidel said that the test demonstrated 80 percent clinical sensitivity compared to an EUA molecular device and clinical specificity of 100 percent.
The test is a lateral flow immunofluorescent sandwich assay and is authorized for use with the Sofia 2 Fluorescent Immunoassay Analyzer. San Diego-based Quidel said it is shipping the assay to its customers, and healthcare professionals can purchase the test through Cardinal Health, Thermo Fisher Scientific's Fisher Healthcare, Henry Schein, and McKesson.
"The EUA for our Sofia 2 SARS Antigen FIA allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient," Quidel President and CEO Douglas Bryant said in a statement.
Separately, the FDA said in a statement that it anticipates authorizing more antigen tests for detecting the coronavirus and expects to provide an EUA template for such tests to help developers streamline submissions and accelerate the agency's review and issuance of EUAs.