This archive report was first published on 10 May 2020.
On May 9, 2020, the U.S. Food and Drug Administration (F.D.A.) took a significant step in the fight against the coronavirus by approving the first antigen test for detecting the virus.
Unlike commonly available coronavirus tests that use polymerase chain reaction (PCR), antigen diagnostics work by quickly detecting fragments of the virus in a sample. The newly approved Quidel test will rely on specimens collected from nasal swabs, which can only be processed by the company's lab instruments.
According to the F.D.A., diagnostic testing is one of the pillars of the nation's response to Covid-19, and the agency continues to take actions to make these critical products available. The F.D.A. expects to grant emergency clearance for other antigen tests in the near future.
Experts say the approval of an antigen test for Covid-19 will boost testing efforts by giving medical workers and health authorities an inexpensive tool for mass rapid testing. Further developed, antigen tests also hold potential for use at home, similar to a home pregnancy kit.
Dr. Ashish Jha, director of the Harvard Global Health Institute, expressed enthusiasm about antigen testing, citing its ability to be scaled up to millions of tests a day and its rapid turnaround. However, he also noted that there are still questions about the sensitivity and specificity of the test.
