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.

Link: https://www.mddionline.com/ivd/thermo-fishers-covid-19-test-could-have-inaccurate-results?ADTRK=InformaMarkets&elq_mid=14179&elq_cid=1077318

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)