FDA: Abbott point-of-care test may return false negative results

Based on early data, the Abbott ID NOW point-of-care test to diagnose COVID-19 may return false negative results, the Food and Drug Administration announced yesterday, adding that it will continue to review data as the company conducts post-market studies to better understand the cause.

"This test can still be used and can correctly identify many positive cases in minutes," said Tim Stenzel, M.D., director of the In Vitro Diagnostics and Radiological Health Office at FDA's Center for Devices and Radiological Health. "Negative results may need to be confirmed with a high-sensitivity authorized molecular test."