F.D.A. Clears First Home Saliva Test for 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 F.D.A. 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 will cost about $100 each, Rutgers said, and must be ordered by a physician.
“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.
Dr. Brooks said the tests should be used only by people who have Covid-19 symptoms. His lab can process 20,000 tests each day, with a 48-hour turnaround, but he expects other labs to adopt it for their own use.
The spit tests are part of a rapid emergency response effort by the F.D.A. 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 come into medical centers to be tested, the spit kits could reduce the risk of spreading the infection to health care workers. They may also appeal to people who would feel more comfortable spitting into a cup than having swabs inserted into their nose.
“This combines the ease of saliva collection with at-home collection,” said Dr. Stephen Hahn, the F.D.A. commissioner, in an interview on Friday.
Some public health experts, however, have cautioned that at-home sampling kits can also come with downsides. One is that it can take longer for people to get test results when they use at-home kits that need to be sent to labs. Because the infection can take several days to develop, they said, the time lag could result in some people receiving false negative test results for coronavirus. Physicians, they said, should make patients aware of the limitations.