FDA flags accuracy issue with widely used coronavirus test
August 18, 2020
WASHINGTON - Potential accuracy issues with a widely used coronavirus test could lead to false results for patients, U.S. health officials warned.
The Food and Drug Administration issued the alert Monday to doctors and laboratory technicians using Thermo Fisher's TaqPath genetic test. Regulators said issues related to laboratory equipment and software used to run the test could lead to inaccuracies. The agency advised technicians to follow updated instructions and software developed by the company to ensure accurate results.
The warning comes nearly a month after Connecticut public health officials first reported that at least 90 people had received false positive results for the coronavirus. Most of those receiving the false results were residents of nursing homes or assisted living facilities.