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4:13 PM, Feb 27, 2020

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FDA expresses concern over Abbott’s instant coronavirus test

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Posted at 10:34 PM, May 14, 2020
and last updated 2020-05-14 22:34:07-04

The Food and Drug Administration issued a warning late Thursday over the accuracy of the highly-touted Abbott instant coronavirus test. Specifically, the FDA said that the test has caused some false negative results.

The Abbott ID NOW coronavirus test has gained popularity after being frequently touted at White House coronavirus task force news briefings. The test gives patients and doctors a result within 15 minutes. But the FDA is concerned that those results are not accurate.

Most other coronavirus tests take two or three days to return a result.

The FDA said it is drafting a letter alongside Abbott to send to patients to notify them of the possibility of an incorrect result.

The FDA added that no test is 100% correct, as performance characteristics, specimen handling, or user error could cause incorrect results.

The Abbott test will still be available as the FDA and the company work on identifying what is causing the false results.

“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue. We will continue to study the data available and are working with the company to create additional mechanisms for studying the test. This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.