FDA Releases Performance Data for More Than 55 Covid-19 Tests
The U.S. Food and Drug Administration released performance data late Tuesday for a slew of Covid-19 diagnostic tests, 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 tests were in short supply in the U.S., companies have rushed to fill the gap with a range of screening options. That has at times led to confusion among consumers and medical professionals about how well they perform.
To assess the products, the FDA shipped a standardized panel of samples to developers starting in May without disclosing how much viral material was in them. The agency is now making the results of that blind test available, detailing how well more than 55 different screenings do in detecting 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 authorized molecular diagnostic tests under the same conditions,” and served as a powerful tool to track test performance.
The agency said that, as of Sept. 10, it has shipped the panel to manufacturers of 152 molecular tests, though not all of the data was returned, some was uninterpretable and other results are still being reviewed. The FDA plans to keep updating the table with results.