FDA Cautions About Reliability Of Abbott Coronavirus Test

The Food and Drug Administration (FDA) is cautioning the public about the accuracy of a widely used rapid test for the coronavirus. The test, made by Abbott Laboratories, has been linked with inaccurate results that could falsely reassure patients that they are not infected with the virus.

The Trump administration has promoted the test as a key factor in controlling the epidemic in the U.S., and it’s used for daily testing at the White House.

As first reported on NPR, about 15-20 out of every 100 tests might bring out falsely negative results. A study released this week indicated that the test could be missing as many as 48% of infections.

The FDA issued the alert on the Abbott test “in the spirit of transparency.” In a press release, the agency said it’s investigating whether the false-negative results could be connected to the type of swab used in the test or the material the samples are stored in for transport.

According to Stenzel, the Abbott rapid test for the coronavirus can still be used to identify positive COVID-19 cases, although negative results might need to go through a secondary process to be confirmed.

The FDA has received 15 “adverse event reports” about the test that indicate patients are receiving inaccurate results, according to the press release.

The FDA will go on to monitor data on the test and work with Abbott, which has agreed to conduct post-market studies on their rapid test. The studies will feature at least 150 people who have tested positive for coronavirus and will be taken in clinical settings, the FDA release said.

Abbott’s share price dropped more than 3% during after-hours trading on Thursday. (Abbott Laboratories is among NPR’s financial supporters.)

In addition, Abbott has continued to defend the accuracy of the test, and pointed to other studies that have found it is as accurate as any other test being used.

Precise, timely testing has been a key challenge in the COVID-19 pandemic. Beyond issues with the reliability of rapid tests, there are also problems certifying antibody tests — those that can detect if someone has been infected with the novel coronavirus in the past.

TVP