FDA authorizes San Diego firm to market first coronavirus antigen test
SAN DIEGO (KUSI) – The Food and Drug Administration has given a San Diego company, Quidel Corp., emergency-use authorization for its COVID-19 antigen test.
Company officials said the FDA gave them permission Saturday to market their Sofia 2 SARS Antigen FIA, a rapid point-of-care test for detecting SARS-CoV-2 in nasal specimens from patients meeting the U.S. Centers for Disease Control and Prevention’s criteria for suspected COVID-19 infection.
“These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs,” the FDA said. “One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes. Positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out 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 chief executive officer of Quidel Corporation.
Currently, there are two types of tests in wide use for COVID-19: polymerase chain reaction, or PCR, tests and antibody tests.
PCR tests are used to diagnose active cases of the disease and are highly accurate but can take longer to show results. Antibody tests work to see if someone’s body has created antibodies to combat the virus, though health experts warn that antibodies don’t necessarily mean that someone is immune to COVID-19.
Antigen tests don’t work in the same way PCR tests do, but can similarly detect if a person is sick with COVID-19.
Antigen tests are also cheaper and easier to mass-produce because of their simplistic design, the FDA said.
Health experts and lawmakers have said widespread testing is key to safely reopening the country, but warn that current testing falls short.