FDA gives OK to at-home saliva test for coronavirus
The Food and Drug Administration said Friday that 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 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.
Brooks said the tests should be used only by people who have COVID-19 symptoms. His lab can process 20,000 tests daily, 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 FDA to help developers of tests for the novel 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.
At a time when some states say they still face a shortage of tests, the athome spit-collection kits have the potential to widen the audience for virus screening. By keeping people with symptoms at home, 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,” Dr. Stephen Hahn, the FDA commissioner, said 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.