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FDA flags accuracy issue with Thermo Fisher SARS-CoV-2 test

August 18, 2020

The FDA has issued an alert to physicians and laboratory technicians using Thermo Fisher Scientific’s (NYSE:TMO) TaqPath genetic test to identify the presence of the SARS-CoV-2 virus.

Issues related to the lab equipment and software used to run the test could lead to inaccuracies. The agency advises lab techs to follow updated instructions and software developed by the company to ensure accurate results.

The warning comes almost a month after health officials in Connecticut reported at least 90 people received false positive results for the coronavirus.

One possible problem may be related to the incorrect use of a centrifuge that spins samples in preparation for processing. The other issue is software-related so labs need to upgrade top a new version.

A company spokesperson says TMO is working with the regulator to ensure that lab personnel understand the need to strictly follow the test protocol, adding that most users “follow our workflow properly and obtain accurate results.”

https://seekingalpha.com/news/3606556-fda-flags-accuracy-issue-thermo-fisher-sars-covminus-2-test

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