The FDA today issued a warning for labs and healthcare providers due to a risk of false results with a Thermo Fisher Scientific (NYSE:TMO) COVID-19 test kit.
Results from the Thermo Fisher TaqPath COVID-19 Combo Kit may be false, based on two issues related to the test kit and the associated Applied Biosystems COVID-19 interpretive software, according to an FDA release.
The first issue relates to inadequate vortexing and centrifugation of RT-PCR reaction plates. Following the company’s investigations into complaints, Thermo Fisher determined that these issues can lead to false-positive results. The company updated the instructions related to vortexing and centrifugation to reduce the risk of innaccuracies.
Additionally, the assay’s internal positive control (IPC) has an issue that requires laboratory staff to upgrade their software to reduce the risk of invalid, potential false-negatives or inconclusive tests in order to decrease the potential need for retesting.
The FDA recommends that users stop using the Applied Biosystems COVID-19 interpretive software v1.2, v2.0 and v2.2 and upgrade their software to version 1.3 or 2.3. For all positive results, users should review the amplification curves within the instrument software to determine whether the plate should be retested due to inadequate vortexing and centrifugation.
