Fox News’ Dr Marc Siegel provides insight into new coronavirus tests and which company wins the fax race.
The Food and Drug Administration on Monday warned health care providers of false-positive coronavirus test results with the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit.
| Ticker | Security | Last | Change | Change% |
|---|---|---|---|---|
| TMO | THERMO FISHING SCIENTIFICALLY | 416.80 | +3.04 | + 0.73% |
The FDA, which approved Emergency Use Authorization (EUA) for the kit in March, said the problem stems from the kit itself as well as from an outdated software system, according to a press release.
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Thermo Fisher Scientific has updated its kit instructions, and the FDA advises medical professionals to implement “direct” software updates 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 the people who got the false results were residents of nursing homes or assisted living facilities.
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A spokeswoman for Thermo Fisher said the company is working with the FDA “to ensure laboratory personnel understand the need for strict adherence to instructions for use,” and data show that most test users “follow our workflow and get accurate results. . “
The FDA has given instructions to health care providers to follow to prevent false results and advises to check certain positive results and take preconditions into consideration with positive tests.
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Lab tests are the backbone of the US coronavirus screening, which accounts for more than half of the roughly 750,000 tests developed daily. The tests look for traces of genetic material of coronavirus in nasal swabs taken from patients.
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The Associated Press contributed to this report.
