FDA Authorizes Low-Cost Rapid-Response Antigen Test for COVID-19

The FDA has issued an Emergency Use Authorization (EUA) to Abbott Diagnostics for its BinaxNOW COVID-19 Ag Card, a rapid-response antigen test for SARS-CoV-2. It is the first antigen test that allows results to be read directly from the testing card itself, similar in design to a pregnancy test, and returns results in about 15 minutes.

The BinaxNOW test is a lateral flow immunoassay intended for the detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swabs. The test can be administered by a health-care provider at point-of-care settings, such as doctor’s offices, schools, and emergency rooms, within 7 days of symptom onset. The Abbott test typically costs $5, while other authorized antigen tests cost between $15 and $50.

According to data from Abbott, the new antigen test is highly specific and accurately detects 97% of positive cases. Rapid antigen tests are less sensitive than lab-based polymerase chain reaction tests, so negative results may need to be confirmed with a molecular test.

Abbott plans to make up to 50 million tests available per month in the U.S. by October.

Sources: FDA press release, August 26, 2020; The Wall Street Journal, August 26, 2020.