April 13, 2020: “A new COVID-19 test developed at Rutgers University that uses saliva samples instead of nasal and throat swabs has gotten emergency approval by the Food and Drug Administration, and is expected to be put out into the field as early as Wednesday.
The test will mean people will need only spit into a tube, rather than submit to swabbing deep into their nasal passages to obtain samples — the current conventional testing method that can be uncomfortable, often painful, and has limited testing nationwide.
Officials said the saliva tests, coupled with a genetic testing service for the coronavirus also developed at Rutgers that can process thousands of samples daily, offering a route to large-scale testing that will be able to greatly increase the numbers of people screened for COVID-19.
“It truly expands the ability to collect and test more samples, not just for us, but for everyone,” said Andrew Brooks, chief operating officer and director of technology development at Rutgers’ RUCDR Infinite Biologics.
RUCDR developed the collection method and a new lab method to greatly increase the number of tests that can be done, in partnership with Spectrum Solutions and Accurate Diagnostic Labs.
The saliva tests will initially be made available to the RWJBarnabas Health network, which has partnered with Rutgers University and includes Robert Wood Johnson University Hospital in New Brunswick and University Hospital in Newark. Those tests will be initially deployed at a Middlesex County coronavirus drive-thru facility on Kilmer Road in Edison, for county residents and first responders, beginning Wednesday. Results are expected to be reported back within 24 to 48 hours, according to county officials.
The FDA granted emergency use authorization to RUCDR and its partners for the saliva collection approach on Friday, which officials said was the first such approval granted by the federal agency. The saliva samples will be analyzed at a Rutgers lab, which also received FDA approval, and will be able to analyze as many as 10,000 samples daily, by using automated lab equipment to perform “nuclear extractions” from collected specimens.
Whether by swab or saliva, the science for detecting COVID-19 is typically the same, utilizing what is known as “standard QPCR approaches.” It’s the same type of molecular analysis already being used in New Jersey. But while highly accurate, the turnaround time for the current testing is slow and the collection of samples through nose swabs is arduous and labor-intensive. The saliva tests, together with new Rutgers-based lab, will make it possible to far expand testing capabilities, said Brooks, who also is a professor in the university’s Department of Genetics.
“We can significantly increase the number of people tested each and every day, as self-collection of saliva is more quick and scalable than swab collections,” Brooks said.
In its authorization letter to Rutgers, the FDA said the test should only be performed “in a health care setting under the supervision of a trained health care provider.” The FDA has not cleared any COVID-19 tests for use at home, though several companies have announced plans to make them available. Additionally, the FDA said patients who test negative with the saliva-based kit should have their results confirmed with a second testing method.” https://www.nj.com/coronavirus/2020/04/a-new-rutgers-coronavirus-test-based-on-a-simple-spit-into-a-tube-will-come-to-a-nj-testing-site-this-week.html
