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

Download Mobile App





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

By HospiMedica 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)

Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)
Gold Member
Disposable Protective Suit For Medical Use
Disposable Protective Suit For Medical Use
Silver Member
Compact 14-Day Uninterrupted Holter ECG
NR-314P
New
Needlefree Closed System Transfer Device
ChemoClave

Print article

Channels

Critical Care

view channel
Image: The permeable wearable electronics developed for long-term biosignal monitoring (Photo courtesy of CityUHK)

Super Permeable Wearable Electronics Enable Long-Term Biosignal Monitoring

Wearable electronics have become integral to enhancing health and fitness by offering continuous tracking of physiological signals over extended periods. This monitoring is crucial for understanding an... Read more

Surgical Techniques

view channel
Image: NTT and Olympus have begun the world\'s first joint demonstration experiment of a cloud endoscopy system (Photo courtesy of Olympus)

Cloud Endoscopy System Enables Real-Time Image Processing on the Cloud

Endoscopes, which are flexible tubes inserted into the body's natural openings for internal examination and biopsy collection, are becoming increasingly vital in medical diagnostics. Their minimal invasiveness... Read more

Patient Care

view channel
Image: The newly-launched solution can transform operating room scheduling and boost utilization rates (Photo courtesy of Fujitsu)

Surgical Capacity Optimization Solution Helps Hospitals Boost OR Utilization

An innovative solution has the capability to transform surgical capacity utilization by targeting the root cause of surgical block time inefficiencies. Fujitsu Limited’s (Tokyo, Japan) Surgical Capacity... Read more

Health IT

view channel
Image: First ever institution-specific model provides significant performance advantage over current population-derived models (Photo courtesy of Mount Sinai)

Machine Learning Model Improves Mortality Risk Prediction for Cardiac Surgery Patients

Machine learning algorithms have been deployed to create predictive models in various medical fields, with some demonstrating improved outcomes compared to their standard-of-care counterparts.... Read more

Point of Care

view channel
Image: The PATHFAST hs-cTnI-II high-sensitivity troponin assay has been developed for the PATHFAST Biomarker Analyzer (Photo courtesy of Polymedco)

POC Myocardial Infarction Test Delivers Results in 17 Minutes

Chest pain is the second leading cause of emergency department (ED) visits by adults in the United States, generating over 7 million visits annually. In the event of a suspected heart attack, physicians... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.