A rapid antigen test directly detects the presence or absence of an antigen, which in the case of COVID-19 is the virus SARS-CoV-2. Antigens induce an immune response in the body.
The US Food and Drug Administration (FDA) on Tuesday granted an emergency use authorization for the first over-the-counter, at-home test for COVID-19.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” FDA Commissioner Stephen M. Hahn said in the release.
Similar to other antigen tests, a small percentage of positive and negative results from the test may be false, according to the FDA. False positives can be common when antigen tests are administered in populations where there is a low prevalence of COVID-19 infection.
“Results are delivered in as little as 20 minutes to individuals via their smartphone. The mobile application requires individuals to input their zip code and date of birth, with optional fields including name and email address, and reports the results as appropriate to public health authorities to monitor disease prevalence,” the FDA explains in its release.
The state-of-the-art COVID-19 test is still the real-time reverse transcription polymerase chain reaction (RT-PCR) test, which detects the genetic material of the coronavirus, according to the FDA and US Centers for Disease Control and Prevention.