FDA warns of false COVID-19 results from Massachusetts based lab kit company

The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers of a risk of false results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit based on two issues related to the test kit and the associated Applied Biosystems COVID-19 Interpretive Software. The test is a molecular assay for the detection of COVID-19 from respiratory specimens.

Thermo Fisher Scientific has their headquarters in Waltham.

According to a release from the FDA, the first issue is related to inadequate vortexing and centrifugation of RT-PCR reaction plates. Thermo Fisher Scientific’s conclusion from investigations of customer complaints indicate that inadequate vortexing or centrifugation can lead to false positive results. Thermo Fisher Scientific has updated these instructions to reduce the risk of inaccurate results. The updated instructions related to vortexing and centrifugation are important for both laboratories performing testing according to the authorized instructions for use and laboratories who are performing validated modifications outside of the authorization.

The second issue is related to the assay Internal Positive Control (IPC) and requires laboratory staff to upgrade their software to reduce the risk of invalid, potential false negatives, or inconclusive tests and to decrease the potential need to retest.