The Food and Drug Administration issued an alert Thursday warning that a common COVID-19 diagnostic test could be giving inaccurate results.
President Donald Trump recently touted Abbott Labs’ ID NOW point-of-care test, which is used by hospitals across the country, as the test used to screen him and those around him.
The FDA issued an emergency use authorization for the test, which can deliver results in five to 13 minutes, in March.
But the test has recently come under fire after studies have indicated that it produces too many false negatives. A small study this week from NYU Langone Health found that the Abbott test returned false negatives for nearly 50 percent of certain samples that a rival test had found to be positive. The study has not been peer reviewed. In response, Abbott said that the results are not consistent with other studies and that the sample size was very small.
The FDA now says patients with negative results from the Abbott test may need to be retested with a more sensitive test.
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“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,” Dr. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement.
“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,” Stenzel said.
In a statement, the FDA said that it is sharing early information in “the spirit of transparency” and that it is working with Abbott. The company will send letters alerting users that any negative test results not consistent with a patient’s clinical symptoms should be confirmed with another test.
So far, the agency has received 15 adverse event reports about Abbott’s test.
In a statement to NBC News, Abbott said that while other studies have shown their test to be reliable and accurate, they are now providing clinicians with more guidance, including proper collection and handling instructions for test samples.