FDA clears first home saliva test for virus
The Food and Drug Administration said Friday it had granted emergency authorization for the first at-home saliva collection kit to test for the coronavirus.
The test kit was developed by a Rutgers University laboratory, called RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs.
Rutgers received FDA permission last month to collect saliva samples from patients at test sites but can now sell the collection kits for individuals to use at home. They must be ordered by a physician.
The agency has come under fire in recent weeks for allowing myriad companies to offer diagnostic and antibody tests without submitting timely data for review, under its emergency use authorization policy because of the pandemic. Tests have varied widely in terms of their accuracy, and access to diagnostic testing has been scattered, with shortages of tests and the materials required to process them straining capacity from one state to another.
To date, 8.1 million people in the United States have been tested for the coronavirus. But public health experts like Dr. Anthony Fauci, the nation’s leading infectious disease expert, said testing needed to double by the end of May.
Just last week, the FDA ordered dozens of companies it had allowed to market antibody tests, which some states and public health experts hope will help indicate the depth of infection in communities and quantify who has recovered and perhaps developed some immunity, to submit data proving accuracy within 10 days, or it warned the products could be removed from the market.
The FDA said Rutgers had submitted data showing that testing saliva samples collected by patients themselves, under the observation of a health care provider, was as accurate as testing deep nasal swabs that the health professional had collected from them. The agency also said the spit collection kits should be limited to people who are exhibiting COVID-19 symptoms.
“A patient can open the kit, spit into the tube, put the cap back on and ship it back to our lab,” said Dr. Andrew Brooks, chief operating officer and director of technology development at RUCDR. “We bring the test to the patient, instead of the patient to the test.”
The FDA said it still preferred tests based on deep nasal samples, which involve a health professional inserting a long swab up through the nose and into the back of the throat.
Rutgers has 75,000 of the saliva test kits ready to ship and can process 20,000 tests each day, with a 48-hour turnaround.
The spit tests are part of an emergency pandemic response effort by the FDA to help developers of novel tests for the coronavirus quickly get to market. Last month, the agency authorized the first type of at-home kit for the virus in the United States, a kit sold by LabCorp that enables people to swab their own noses and send the samples to be tested at the company’s labs around the country.
Now, at a time when some states say they are still facing a shortage of tests, the at-home spit-collection kits have the potential to widen the audience for virus screening. By keeping people with symptoms at home, instead of asking them to go to medical centers to be tested, the spit kits could reduce the risk of spreading the infection to health care workers.
They might also appeal to people who would feel more comfortable spitting into a container than inserting swabs into their noses to collect virus specimens.
“This combines the ease of saliva collection with at-home collection,” Dr. Stephen Hahn, the FDA commissioner, said in an interview Friday.