RUCDR Infinite Biologics laboratory at Rutgers University received modified emergency clearance on Thursday. With the test, people can collect their own saliva at home and send their saliva samples to a laboratory for results.
So far, tests for Covid-19 have generally involved swabs from the nose or throat.
In April, Rutgers University announced that the FDA had approved the saliva test it had developed with other groups for “emergency use” for the diagnosis of Covid-19.
“What’s new and next is to expand testing access for people,” Andrew Brooks, director of operations and director of technology development at RUCDR Infinite Biologics, told CNN.
Brooks said the test includes instructions on how to spit in a funnel to collect a saliva sample and seal with a cap to preserve the sample. A preservative will appear, blue in color, and once the entire sample is blue, it is returned to a biohazard bag provided with the kit and sent to a laboratory for analysis.
“Authorizing additional diagnostic tests with the option of taking samples at home will continue to increase patient access to COVID-19 tests. This provides an additional option for easy, safe and convenient collection of samples necessary for testing without going to a doctor. office, hospital or test site, “said FDA Commissioner Dr. Stephen M. Hahn on Friday.
“We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic,” said Hahn. “The FDA has authorized more than 80 COVID-19 tests and the addition of more options for home sample collection is an important step forward in diagnostic testing during this public health emergency. “
The FDA noted in its press release that the Rutgers test is currently the only authorized Covid-19 diagnostic test that uses saliva samples to test the new coronavirus. The test remains only on prescription.
Another prescription test kit, manufactured by LabCorp, received FDA approval in April and allows patients to collect their own samples by nasal swab and send them to a laboratory for testing.
CNN’s Shawn Nottingham and Allison Flexner contributed to this report.