F.D.A. Clears the first home saliva test for coronavirus

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The test kit was developed by a laboratory at Rutgers University, called RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs. The

The agency has been criticized in recent weeks for allowing a myriad of companies to offer diagnostic and antibody tests without submitting timely data for review, in accordance with its licensing policy. emergency due to the pandemic. Tests have varied considerably in terms of accuracy, and access to diagnostic tests has been dispersed, with test shortages and the materials needed to process them, constraining state-to-state capacity.

To date, 8.1 million people in the United States have been tested for coronavirus. But public health experts like Dr. Anthony Fauci, the country’s leading infectious disease expert, said tests should double by the end of May.

Last week, the F.D.A. Ordered dozens of companies licensed to market antibody tests, which some states and public health experts say will help indicate the depth of infection in communities and quantify who has recovered and possibly developed some immunity, to submit data proving their accuracy within 10 days, or he warned that the products could be withdrawn from the market.

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