FDA Issues Alert on Accuracy of Rapid Test for Coronavirus

Preliminary data suggest that Abbott Labs' ID NOW rapid test for COVID-19, currently being used to reportedly screen White House staff, may give false negative results, the US Food and Drug Administration (FDA) said in an alert late Thursday.

To date, the FDA has received 15 adverse event reports about the Abbott ID NOW test that suggest some users are receiving inaccurate negative results, the agency said.

Some studies have identified accuracy issues with Abbott's test, and the agency is investigating whether this could be due to the types of swabs used or the type of viral transport media.

"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," Tim Stenzel, MD, PhD, director, Office of In Vitro Diagnostics and Radiological Health, FDA Center for Devices and Radiological Health, said in the alert 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," he said.

"While we understand no test is perfect, test outcomes depend on a number of factors including patient selection, specimen type, collection, handling, storage, transport and conformity to the way the test was designed to be run," Abbott said in a press statement.

The ID NOW test should be used with a direct-swab test method. Abbott said negative results should be presumed negative, "but if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with an alternative molecular assay."

The FDA is working with Abbott to analyze the data and is sharing the preliminary data about potential accuracy concerns "in the spirit of transparency."

The FDA said Abbott will conduct postmarket studies for the ID NOW test that each will include at least 150 COVID-19 patients in a variety of clinical settings. These studies will help shed light on the cause or patterns of any accuracy issues and inform any additional actions the company or the FDA should take, the agency said.

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Reviewed on 5/20/2020

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