FDA Warns About Possible False COVID-19 Test Results

United States health officials are sending out a warning over accuracy issues with an extensively used coronavirus test that could lead to incorrect results for patients.

On Monday (8/17), the Food and Drug Administration sent out the alert to doctors and lab technicians who use Thermo Fisher’s TaqPath genetic tests. According to regulators, the issues came from the laboratory equipment and software used to run the tests. Technicians are being advised to use updated instructions and software created by the testing company for accurate results.

The FDA said one possible problem was related to the incorrect use of equipment that quickly spins samples in preparation for processing.

The alert comes about a month after public health officials in Connecticut reported that at least 90 people received false-positive test results for COVID-19. The patients were residents of nursing homes and assisted living facilities.

According to Thermo Fisher’s spokeswoman, the company is working with the FDA “to make sure that laboratory personnel understands the need for strict adherence to the instructions for use." She also added that company data shows most users “follow our workflow properly and obtain accurate results.”

In mid-March, the company’s test was granted emergency use by the FDA. The same test runs on a large, automated machine used in hospital, government, and commercial labs to look for diseases such as HIV, hepatitis, and the flu.

According to the FDA, they have used their emergency powers to OK to more than 200 tests for coronavirus since February.

Photo: Getty Images

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