This Is Why You May Test Positive for COVID Even If You Don't Have It
A new FDA report is highlighting major flaws with a commonly used coronavirus test.
While some people with the coronavirus may experience an array of symptoms, others show no signs of infection at all. And given that the most common symptoms—cough, fever, and shortness of breath—can also be signs of other respiratory illnesses, like the flu, it can be hard to know whether you have COVID-19 or not. That's why many people get tested every day. Unfortunately, the results don't always get it right. And according to the U.S. Food and Drug Administration (FDA), Thermo Fisher's TaqPath test is one of the ones returning false findings.
The FDA issued a public statement on Aug. 17, notifying laboratories and healthcare providers that there is a "risk of false results" associated with the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit, a swab test conducted either on your throat or nose that can produce results in just a few hours.
At the time of publishing, no information on how many false positives were issued from the test had been released by the FDA. However, the statement came just a few weeks after the Connecticut Department of Public Health reported that 90 people tested between June 15 and June 17 received false positive results. And according to the Hartford Courant, the individuals were tested through Thermo Fisher's system.
The FDA says this system's false positives are the result of two issues: incorrect use of test equipment and outdated testing software. The FDA recommends that any laboratory staff and healthcare providers using the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit immediately update their software and read the latest set of instructions to prevent incorrect equipment usage.
According to the Associated Press (AP), Thermo Fisher's test was approved by the FDA for use in mid-March—just one of the more than 200 coronavirus testing methods that the agency had approved since February. In a public statement, a spokesman for Thermo Fisher said that they were working with the FDA "to make sure that laboratory personnel understand the need for strict adherence to the instructions for use."
The AP says that a small percentage of false positives and false negatives are expected with any coronavirus test. In fact, one review of coronavirus tests found that anywhere between 2 to 29 percent could be false negatives. And according to experts at Harvard Medical School, false positives are less likely, with a reported rate of 5 percent or lower. Regardless, however common inaccurate results are or are not, the FDA's recent announcement is a concerning one as the country continues to try to contain the spread of COVID-19. And for more on tracking the coronavirus, check out This Is Exactly When You Need a COVID Test, Doctor Says.