Many steps needed for accurate COVID-19 test results
WASHINGTON (AP) — A widely used coronavirus test is under scrutiny this week after federal health officials warned that it could deliver inaccurate results if laboratory technicians don't follow the the latest updates from the manufacturer.
The Food and Drug Administration's warning over Thermo Fisher's TaqPath test underscores the complexity of COVID-19 tests and how easily they can be skewed by faulty processing and equipment.
The FDA action follows a report last month by Connecticut public health officials that the test resulted in at least 90 people receiving false positive results for the coronavirus.
WHAT HAPPENED WITH THE TEST?
Thermo Fisher’s test is one of the standard tools used to screen for COVID-19, run on large, automated machines found in many U.S. hospitals and laboratories. The FDA flagged two separate issues that could potentially result in false results: the chemical mixing process and computer software that runs on the company's machine. Thermo Fisher has provided new instructions for mixing. And a software update fixes the second problem, the FDA said.
For all positive results, FDA said labs should review the instrument settings.
Thermo Fisher said in a statement that its data shows the issues are rare and most users get accurate results by following company directions.
HOW ACCURATE ARE COVID-19 TESTS?
No test is 100% accurate and all medical tests are expected to deliver a certain small portion of false results. Less is known about the accuracy of COVID-19 tests because of how quickly they were rushed through the regulatory process because of the pandemic.
Thermo Fisher's test uses molecular technology that is considered the gold standard for detecting the COVID-19 virus and other viruses. The test uses chemicals to extract the genetic...
