The FDA authorized its first COVID-19 antigen test, bringing a new category of diagnostic against the disease.
Similar to the rapid, swab-based tests used for different strains of the flu, antigen tests detect the unique fragments of proteins found on the outer walls of the novel coronavirus—as opposed to antibody tests, which gauge the body’s immune response, or molecular tests, which search for specific genetic sequences linked to the virus.
Quidel’s Sofia 2 SARS Antigen FIA test was given the green light by the agency for use in equipped laboratories as well as for point-of-care testing in hospitals, urgent care clinics and other areas.
According to the FDA, antigen tests can be cheaper and offer a simpler design while providing results in minutes, but they are not as sensitive and may not detect as many active infections as molecular tests. Though accurate, with a very low rate of false positives, negative results from an antigen test may not completely rule out an infection.
“In the fight against COVID-19, our employees are truly making a difference, and I am tremendously proud of our organization’s ability to quickly develop and mobilize an accurate rapid antigen test,” said Douglas Bryant, president and CEO of Quidel, which previously received an FDA Emergency Use Authorization for a molecular COVID-19 test.
“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,” Bryant said.
The FDA said it expects to authorize more antigen tests for use in the near future and will provide a specific template to developers for regulatory submissions.