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



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Photographer: Eve Edelheit / Bloomberg

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

9, in an effort to help doctors, labs and patients evaluate competing products.

There are over 100 tests on the market for Covid-19. Since the early days of the pandemic, when evidence was scarce in the U.S., companies have rushed to fill the gap with several selection options. This has sometimes led to confusion among consumers and medical professionals about their performance.

To evaluate the products, the FDA sent a standardized sample panel to developers from May without revealing the amount of viral material they contained. Now the agency is conducting the the results of this blind test are available, detailing the performance of more than 55 different tests in the detection of infections.

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

The agency said that as of Sept. 10, it has sent the panel to manufacturers of 152 molecular tests, although not all data was returned, some were uninterpretable and other results are still being reviewed. The FDA plans to continue updating the table with the results.


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