FDA Releases Performance Data for Over 55 Kovid-19 Tests

Photographer: Eve Adelheit / Bloomberg

The US Food and Drug Administration released performance data late Tuesday for a group of Kovid-19 clinical trials in an effort to help doctors, laboratories, and patients evaluate competing products.

There are over 100 tests on the market for the Kovid-19. Since the early days of the epidemic, when tests were in short supply in the US, companies have run to fill the gap with a range of screening options. This sometimes causes confusion among consumers and medical professionals about how well they perform.

To assess the products, the FDA sent a standardized panel of samples to developers starting in May, revealing how much viral material they contained. Agency is now making The results of the available blind tests perform more than 55 different tests to detect infection.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said Release said the panels “provided valuable insights into the comparative performance of various authorized molecular diagnostic tests under the same conditions,” and served as a powerful tool to track test performance.
The agency said that, as of September 10, it has sent the panel to the manufacturers of 152 molecular tests, although all the data was not returned, some were unobstructed and other results are still being reviewed. The FDA plans to keep the table updated with the results.


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