FDA Approves First Antigen Test To Detect Coronavirus
The U.S. Food and Drug Administration issued the first emergency use authorization or EUA to Quidel Corp.’s COVID-19 antigen test. The Sofia 2 SARS Antigen FIA test will be used for the rapid detection of the coronavirus and is considered to play a critical role in the fight against the COVID-19 pandemic.
The FDA noted that these new categories of the diagnostic test quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs.
The Sofia 2 SARS Antigen FIA test is authorized for use in high and moderate complexity laboratories certified by Clinical Laboratory Improvement Amendments or CLIA. It can also be used for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.
According to the agency, diagnostic testing is one of the major initiatives by the government to fight against COVID-19. To date, the FDA has issued EUAs for two types of tests, such as polymerase chain reaction tests that detect the genetic material from the virus, and serological tests that look for antibodies in the virus.
PCR tests can be incredibly accurate, but running the tests and analyzing the results can take time. Compared to PCR tests, an antigen test is very quick and could provide results in minutes. Antigen tests may not detect all active infections, but are very specific for the virus, and not as sensitive as molecular PCR tests.
Positive results from antigen tests are considered to be highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection.
The agency pointed out that negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.
Further, antigen tests are important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests. It is expected that the entry of multiple manufacturers in the market can potentially scale to test millions of Americans per day.
The FDA said it anticipates providing a EUA template for antigen tests to help manufacturers streamline submissions and help expedite its review and issuance of additional EUAs.
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