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FDA allows public use of Saliva-based COVID-19 test

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FDA allows public use of Saliva-based COVID-19 test

Today, the U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT)

The U.S. Food and Drug Administration issued an emergency authorization on Saturday allowing public use of a saliva-based test for the coronavirus developed at Yale University and funded by the NBA and the National Basketball Players Association.

The test, known as SalivaDirect, is designed for widespread public screening. The cost per sample could be as low as about $4, though the cost to consumers will likely be higher than that -- perhaps around $15 or $20 in some cases, according to expert sources.

Yale administered the saliva test to a group that included NBA players and staff in the lead-up to the league's return to play and compared results to the nasal swab tests the same group took. The results almost universally matched, according to published research that has not yet been peer-reviewed.

The leading coronavirus saliva test, developed at a Rutgers University lab and given the same permission by the FDA in mid-April, costs individual consumers up to $150 -- though that can be reduced to $60 or $70 in some circumstances, said Andrew Brooks, an associate professor at Rutgers and chief operating officer of RUCDR Infinite Biologics, the lab behind the test. The Rutgers test can be taken at home and returns results in 24 to 48 hours.

Several NBA teams used the Rutgers test in June, and Brooks said several sports teams are still using it. Those teams fly saliva samples to one of several labs -- including the Rutgers lab in New Jersey -- approved for administering the test, which adds time and cost....

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