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May 15, 2020: FDA Issues Public Alert Regarding Accuracy Concerns With Abbott ID NOW Point-of-Care Test for Diagnosing COVID-19

On May 15, 2020, the U.S. Food and Drug Administration (FDA) issued an alert for the public advising that early data for the Abbott ID NOW point-of-care test, used to diagnose COVID-19 (coronavirus), suggest possible inaccurate results which elicit false negatives.

Abbott ID NOW COVID-19 Test Alert Information

The FDA is issuing this information as a gesture of transparency regarding testing. They are working closely with Abbott to review the available data and information. Abbott is collaborating with the FDA to draft a customer notification letter alerting consumers that any negative test results not consistent with a patient’s clinical signs and symptoms should be followed up and confirmed with another test.

Per 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:

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.

FDA officials will continue to review data and information as it becomes available.

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