FDA alerts laboratories, providers to risk of false results with COVID-19 test kit

A test kit made by Thermo Fisher Scientific to detect COVID-19 from respiratory specimens may produce false positive results, the Food and Drug Administration warned yesterday.

The agency recommends that clinical laboratories and health care providers using the TaqPath COVID-19 Combo Kit promptly implement updates to the software and use instructions, among other actions.

FDA in March authorized the test for emergency use by U.S. laboratories certified to perform moderate and high complexity tests under the Clinical Laboratory Improvement Amendments. The agency is working with Thermo Fisher Scientific and public health partners to resolve the problem and plans to update the public as information becomes available.