FDA warns of possible accuracy concerns with Abbott ID NOW point-of-care test

FDA is warning that preliminary data suggest that the Abbott ID NOW point-of-care test for diagnosing COVID-19 may return false negative results.

FDA is warning that preliminary data suggest that the Abbott ID NOW point-of-care test for diagnosing COVID-19 may return false negative results. "We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue," said Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in FDA's Center for Devices and Radiological Health. "We will continue to study the data available and are working with the company to create additional mechanisms for studying the test." Stenzel noted that the test can still be used and can accurately identify many positive cases of COVID-19 in just minutes, but "negative results may need to be confirmed with a high-sensitivity authorized molecular test." FDA said it is "sharing early information available about potential inaccurate results in the spirit of transparency. The agency has been working with Abbott to analyze the information gathered to date and has worked with the company on a customer notification letter to alert users that any negative test results that are not consistent with a patient's clinical signs and symptoms or necessary for patient management should be confirmed with another test." FDA has received 15 adverse event reports about the Abbott ID NOW device that suggest some users are receiving inaccurate negative results. The agency said it is reviewing those reports, but it also noted "the adverse event reports the FDA receives from manufacturers, health care providers, health care facilities, and patients can be incomplete, inaccurate, or unverified, so agency staff must meticulously comb through the reports to identify crucial data to support any signals or patterns about device use." Abbott has agreed to conduct post-market studies for the device that each will include at least 150 COVID-19 positive patients in several clinical settings, and FDA said it will continue to review interim data on an ongoing basis.