FDA ‘False Results’ Alert on Thermo Fisher Covid Tests

FDA is alerting clinical laboratory staff and health care providers about a risk of false results with Thermo Fisher Scientific TaqPath Covid-19 Combo Kit based on two issues related to the test kit and its associated Applied Biosystems Covid-19 Interpretive Software. The test is a molecular assay for detecting Covid-19 from respiratory specimens.

“The first issue is related to inadequate vortexing and centrifugation of RT-PCR reaction plates, an FDA alert says. The company’s conclusion from investigations indicates that inadequate vortexing or centrifugation can lead to false positive results, it says. The second issue is related to the assay Internal Positive Control 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.