The Food and Drug Administration on Monday warned health care providers of false-positive coronavirus test results using the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit.
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The FDA, which approved Emergency Use Authorization (EUA) for the kit in March, said the issue stems from the kit itself as well as an outdated software system, according to a press release.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 is recommending medical professionals "promptly" implement software updates to reduce the frequency of false-positive results, Fox Business reported on Tuesday.
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 receiving the false results were residents of nursing homes or assisted living facilities.
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A Thermo Fisher spokeswoman said the company is working with the FDA "to make sure that laboratory personnel understand the need for strict adherence to the instructions for use," and data shows most test users "follow our workflow properly and obtain accurate results.”
The FDA provided instructions for health care providers to follow to avoid false results and recommends they consider retesting certain positive results and take preexisting conditions into mind with positive tests.
Lab tests are the backbone of U.S. screening for coronavirus, accounting for more than half of the roughly 750,000 tests developed daily. The tests look for traces of coronavirus’ genetic material in nasal swabs taken from patients.
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