FDA Warns of False Coronavirus Test Results from Thermo Fisher Kit

The Food and Drug Administration on Monday notified healthcare providers of false positive coronavirus test results using the Thermo Fisher Scientific TaqPath COVID-19 combo kit.

The FDA, which approved Emergency Use Clearance (EUA) for the kit in March, said the issue stems from the kit itself as well as an outdated software system, according to a press release.

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Thermo Fisher Scientific has updated its kit instructions and the FDA recommends that healthcare professionals implement software updates “promptly” to reduce the frequency of false positive results.

Lab technician James Donald, right, uses a nasal swab to test Hugo Marti for COVID-19, July 28, 2020, at the AHEPA apartments in Miami. (AP Photo / Wilfredo Lee)

The warning comes nearly a month after Connecticut public health officials first reported that at least 90 people had received false positive results for the coronavirus. Most of those who received the false results were residents of nursing homes or assisted living facilities.

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A spokesperson for Thermo Fisher said the company is working with the FDA “to ensure that laboratory staff understand the need to strictly adhere to the instructions for use,” and the data shows that most test users “correctly follow our workflow and get accurate results.”

The FDA has provided instructions for healthcare providers to follow to avoid false results, and recommends that they consider retesting some positive results and considering pre-existing conditions with positive tests.

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Laboratory tests are the backbone of U.S. testing for the coronavirus, accounting for more than half of the approximately 750,000 tests developed daily. The tests look for traces of genetic material from the coronavirus in nasal swabs taken from patients.

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The Associated Press contributed to this report.