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FDA releases performance data for more than 55 Covid-19 tests

The Florida governor issues orders for residents to stay home

Photographer: Eve Edelheit / Bloomberg

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

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

There are more than 100 tests on the Covid-19 market. Since the early days of the pandemic, when testing was in short supply in the United States, companies have been quick to fill the gap with a range of screening options. This has at times led to confusion among consumers and medical professionals about how well they are doing.

To evaluate the products, the FDA sent a standardized panel of samples to developers, starting in May without revealing how much viral material was in them. The agency is doing now the results of the available blind test, which describes how well more than 55 different screenings do to detect infection.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a release that the panels provided “valuable insight into the comparative performance of different approved molecular diagnostic tests under the same conditions”, and served as a powerful tool for tracking test performance.

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

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