We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Abbott Diagnostics

Download Mobile App





FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests

By LabMedica International staff writers
Posted on 18 Sep 2020
Print article
Illustration
Illustration
The US Food and Drug Administration (FDA Silver Spring, MD, USA) has published comparative performance data for some authorized COVID-19 molecular diagnostic tests.

The data show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the agency. The FDA has provided these standardized samples, known as a reference panel, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their Emergency Use Authorization (EUA). The FDA began distributing the reference panel of samples in May and has provided it to more than 150 developers as a resource in the development and validation of accurate and reliable diagnostic tests. In order to ensure accuracy of test results using the reference panel, the FDA has not disclosed the amount of viral material in the samples, resulting in a blind test for developers.

In the latest published data, a lower LoD represents a test’s ability to detect a smaller amount of viral material in a given sample, signaling a more sensitive test. However, the data does not indicate how sensitive a particular test is, and, therefore, cannot be used by itself to determine whether to authorize a test or other regulatory action. Instead, the data gives laboratories, healthcare providers and patients a new resource on the relative performance of available tests to better inform which tests they choose to use. The FDA will continue to update the data as it receives additional results.

“By providing this panel to both commercial and laboratory test developers and evaluating the data we receive, we are able to gain valuable insight into the comparative performance of different authorized molecular diagnostic tests under the same conditions,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “Reference panels can be used in many ways to support test development and authorization, but most importantly, they are a powerful tool in monitoring test performance and ensuring that Americans have access to diagnostics they can trust.”

Related Links:
US Food and Drug Administration (FDA)


Print article
BIOHIT  Healthcare OY

Channels

Industry News

view channel
Image: Mindray Hematology Solution Helps High-Volume Lab Run 2,820,000 CBC Tests Annually (Photo courtesy of Mindray)

Mindray Hematology Solution Helps High-Volume Lab Run 2,820,000 CBC Tests Annually

High-volume laboratories face several challenges, including high instrument failure rate, errors due to several manual steps, low efficiency and long TAT, and heavier workload for the lab staff.... Read more
Copyright © 2000-2020 Globetech Media. All rights reserved.