Abbott’s POC Test to Diagnose COVID-19 May Be Inaccurate, FDA Issues Alert
Yesterday FDA issued a public alert concerning the inaccuracy of the Abbott ID NOW point-of-care test used to diagnose COVID-19. The agency has received 15 adverse event reports, which indicates that the test may return false negative results.
“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 CDRH in an agency news release. He added that FDA is in direct communication with Abbott about the issue. Abbott will be conducting postmarket studies for the ID NOW test, the results of which will be used by FDA to assess whether there are patterns related to the accuracy issues.
FDA also referred to scientific studies that have called out accuracy issues of the Abbott ID NOW test. It is looking into whether the problem may be a result of the types of swabs being used or the viral transport media.
Related Articles
-
Effective February 7, the agency will conduct inspections across all commodities, as well as mission-critical foreign and domestic inspections.
-
The omicron variant of the coronavirus has made clear that the impact of the pandemic is far from over, particularly for health systems and hospitals. The ongoing need to limit close contact between providers and patients means technology will continue…
-
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
-
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
