Accuracy problems with a widely used coronavirus test could lead to false results for patients, the US Food and Drug Administration (FDA) warns. Connecticut state public health officials have reported people having received false positives.
The US Food and Drug Administration (FDA) issued the alert to doctors and laboratory technicians using Thermo Fisher’s TaqPath genetic test. Regulators said problems related to the equipment and software used to administer the test could lead to inaccuracies.
The first drawback is related to the equipment for centrifuging the samples. The second, with the software used in the Thermo Fisher platform to carry out the tests.
In July, Connecticut state public health officials reported that at least 90 people had received false positives. The FDA instructed the laboratories to follow the new instructions and to update the software to a new version.
The health authority authorized the emergency use of the Thermo Fisher test in mid-March. The test is placed in an automated machine that is used in many commercial laboratories to detect diseases such as HIV, hepatitis, and flu.
These tests make up a large portion of the thousands that are performed daily in the US. The North American country continues to be the most affected by the SARS-CoV-2 coronavirus pandemic, which causes the COVID-19 disease, with more than 5.4 million registered cases and 170,000 deaths.