FDA Warns of False Negative Risk in Rapid COVID-19 Test

The United States Food and Drug Administration (FDA) issued a warning on May 14 regarding the risk of false negative testing results with the Abbott ID Now test, which provides point-of-care diagnosis of COVID-19 infection. The test received emergency authorization from the FDA on March 27; however, some studies have shown the test may produce false negative results. The FDA is currently working with Abbott to further study the test’s efficacy but advises that those who have received a negative test result should follow up with a “high-sensitivity authorized molecular test.” The test is effective at diagnosing positive cases of COVID-19, and the company suggests the studies demonstrating a high number of false negatives were problematic, citing possible problems with the swabs used and the mode of transport for the specimens. Read more here.