The U.S. Food and Drug Administration (FDA) has announced the approval of the first authorized diagnostic antigen test for COVID-19, the infection caused by the novel coronavirus called SARS-CoV-2.
The point-of-care COVID-19 antigen test, which can be used without an analyzer, is called BinaxNOW COVID-19 Ag Card. In some ways, it is pretty much similar to a home pregnancy test.
With this antigen test, clinicians could read the results on a card — two lines for a positive result and one line for negative.
After collecting nasal swabs from a symptomatic patient, the sample is twirled on a test card with a reagent. The result can be obtained approximately within 15 minutes of the test. No any other equipment is needed.
Abbott develops BinaxNOW COVID-19 Ag Card. The company expects the antigen test to cost around $5.00.
The point-of-care test can be used easily by office-based physicians, ER physicians, and school nurses.
The FDA approved the Emergency Use Authorization (EUA) for the test. The agency approved the test for people suspected of having coronavirus who are within 7 days of symptom onset.
Dr. Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health, wrote in a news release, “This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card. This means people will know if they have the virus in almost real-time.”
Marcus Lynch of the Health Care Horizon Scanning program at ECRI told Medscape Medical News, “This fits into the testing landscape as a simple, inexpensive test that does not require additional equipment.”
ECRI is an independent, nonprofit organization improving the safety, quality, and cost-effectiveness of care across all healthcare settings worldwide. It also reviews and analyzes coronavirus diagnostics and therapeutics.
Lynch said the rapid antigen diagnostic test could help with early triage of patients who test positive, alerting doctors start COVID-19 therapy.
However, the FDA cautioned that antigen tests are generally less sensitive than molecular assays.
“Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the agency said.
Lynch agreed to what the FDA says and explained that when patients test negative, doctors still need to use their clinical judgment based on symptoms and other factors.
BinaxNOW COVID-19 Ag Card is not designed for population-based screening of asymptomatic people, Lynch added.
Abbott announced that it is planning to make nearly 50 million tests available per month in the United States from October. The company said the product comes with a free smartphone app that one can use to share results with their employers or with others as required.
