Thursday 3 September 2020

Concern over COVID-19 test kit

The U.S. FDA has altered clinical laboratory staff of a risk of false results with ThermoFisher’s TaqPath COVID-19 Combo Kit. Thus is linked with two issues related to the test kit (imprecise instructions on sample preparation for the PCR plates and a concern with the positive contort); and one issue related to the Applied Biosystems COVID-19 Interpretive Software used to produce the test results.

TaqPath was fast tracked by the FDA and in Europe in March 2020.


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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