Home / Health / The FDA publishes performance data for more than 55 Covid-19 tests

The FDA publishes performance data for more than 55 Covid-19 tests



Florida governor issues orders for residents to stay home

Photographer: Eve Edelheit / Bloomberg

The U.S. Food and Drug Administration released performance data for a series of Covid-1

9 diagnostic tests on Tuesday in an effort to help doctors, labs and patients evaluate competing products.

There are more than 100 tests on the market for Covid-19. Since the early days of the pandemic, when testing was in short supply in the United States, companies have rushed to close the gap with a range of screening options. At times this has led to confusion among consumers and medical professionals about their performance.

To evaluate the products, the FDA sent a standardized panel of samples to developers starting in May without disclosing the amount of viral material contained in them. The agency is now making the Results from that blinded test are available, detailing how well more than 55 different screens are effective in detecting infection.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a release that the panels have provided “valuable information on the comparative performance of several licensed molecular diagnostic tests under the same conditions” and served as a powerful tool for monitoring test performance.

The agency said it had shipped the panel to the makers of 152 molecular tests as of September 10, although not all data has been returned, some were uninterpretable, and other results are still under review. The FDA plans to continue updating the results table.


Source link