EDISON, NJ — A groundbreaking saliva test for the new coronavirus developed by researchers at Rutgers University’s Human Genetics Institute — one that uses patients’ spit samples instead of a painful nasal swab — has just been granted approval from the Food and Drug Administration and will go into use this week in New Jersey.
For the first time anywhere in the United States, the saliva tests will be offered to the general public starting Wednesday at the Edison Motor Vehicle Commission test site on Kilmer Road.
Rutgers said the White House’s COVID-19 task force is working with the university to make these tests available nationwide.
Middlesex County officials say that, to the best of their knowledge, the Edison location is the first test site in the nation to begin offering coronavirus saliva testing in a drive-thru setting.
To be tested at the Kilmer Road site, people must make an appointment in advance. More information on how to make an appointment and site hours is below. The testing is free.
The Rutgers scientists who invented the coronavirus saliva testing say the benefits are threefold. First, the test is less painful and less invasive than the existing test. Instead of having a swab far into the upper nasal cavity — it’s been described as excruciating — patients now simply provide a spit sample into a test tube, in what the researchers call “spit and seal.” Patients can also provide the spit-in-a-test tube sample themselves; they do not need to be taken by a healthcare worker.
Second, test results are much faster. Instead of three to five days, test results are available within 24 to 48 hours, a Middlesex County spokeswoman said. Third, because the saliva tests can be processed more quickly, more people can be tested in one day — potentially up to 10,000 per day.
The coronavirus saliva tests were developed at Rutgers’ RUCDR Infinite Biologics, led by chief operating officer Andrew Brooks, in partnership with Spectrum Solutions and Accurate Diagnostic Labs (ADL), both privately owned labs. RUCDR Infinite Biologics, which is part of Rutgers’ Human Genetics Institute of New Jersey, is the world’s largest university-based cell and DNA repository. RUCDR Infinite Biologics is based in Piscataway.
The saliva testing method is based on a Nobel Prize-winning laboratory technique that makes millions of copies of the SARS-CoV-2 virus nucleic acid (in this case RNA) in a sample.
As Patch reported, Rutgers unveiled the coronavirus saliva tests April 2. However, because the tests lacked FDA approval, it was only offered to patients and first responders — doctors and nurses — within the Robert Wood Johnson Barnabas Health network, a Rutgers partner.
However, this past weekend, the FDA granted what’s known as “emergency use authorization” to give the saliva tests to the general public. It’s the first time the FDA has given such emergency approval, according to a Rutgers news release. The FDA letter that gives emergency approval has been made publicly available, and it can be read it here.
According to the news release, the FDA approved the tests Saturday and, that same day, Brooks said he received a call from the White House’s COVID-19 task force offering congratulations and asking about any specific hurdles to expand the testing nationwide.
“The impact of this approval is significant,” said Brooks, who also is a professor in the Rutgers genetics department. “It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections. We can preserve precious personal protective equipment for use in patient care instead of testing. 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. All of this combined will have a tremendous impact on testing in New Jersey and across the United States.”
With that approval in hand, the saliva tests is to be rolled out to the Edison MVC test site starting Wednesday. The test tube samples will be analyzed by RUCDR Infinite Biologics at their Piscataway labs.
Two other start-up companies, MicroGen DX and Vault Health, are unveiling what they say are at-home saliva tests for coronavirus; Vault’s test is available now on their website. RUCDR Infinite Biologics is also working with Vault to distribute their tests nationwide through telemedicine.
The saliva tests will only be available there Monday, Wednesday and Friday of each week. The Edison test site is at the Kilmer Vehicle Inspection/Driving Testing Center, a COVID-19 drive-thru testing facility on 33 Kilmer Road in Edison.
Brooks also predicted the sheer volume of samples that now can be tested will also help scientists come up with a coronavirus vaccine. The Rutgers RUCDR Infinite Biologics team is working to expand the coronavirus saliva testing nationwide.
The Edison test site was chosen because it is located very close to the Piscataway research labs of RUCDR Infinite Biologics. Middlesex County also already had the existing infrastructure and operational capabilities to introduce the new type of tests.
“We believe our state-of-the-art drive-thru model can set a benchmark for testing that can benefit the state and other counties,” said Middlesex County Freeholder Director Ronald Rios. “Middlesex County has built the operations and infrastructure from the ground up to enable us to provide innovative solutions.”
To get tested:
The criteria to get tested does not appear to have changed. First, you must be a Middlesex County resident (valid driver’s license or state-issued identification is required); make an appointment online or via phone; and have either a valid doctor’s prescription or be exhibiting symptoms that include a fever of 100.4 degrees or higher (99.6 degrees for people 65 years and older), respiratory symptoms and/or shortness of breath.
Middlesex County residents who have symptoms and would like to be tested should visit Middlesexcountynj.gov/COVID19testing to make an appointment. They will be assigned a time to report to the testing site.
Registrants must bring the completed registration form and proof of residency including, but not limited to: a valid driver’s license; state issued identification; or two pieces of mail including utility bills, bank statements, or similar documentation with name and address, to the testing site.
If a resident does not have access to the internet or is having connectivity problems, they are instructed to call 732-745-3100 to make an appointment (from 10 a.m. to 4 p.m.). Appointments will only be made the day prior to a testing day.
If the person is not a Middlesex County resident, does not have a scheduled appointment or does not have symptoms, they will not receive testing.
Residents can visit the Middlesex County website at www.middlesexcountynj.gov/COVID-19 or contact 211 for information about the testing site, as well as call the Middlesex County Office of Health Services at 732-745-3100.
Residents who have questions about COVID-19 they can call 211 or the 24-hour public hotline at 800-962-1252 or 800-222-1222, or text NJCOVID to 898-211. They can also text a ZIP code to 898-211 for live text assistance.
Edison DMV Inspection Center Turned Into Coronavirus Test Site (March 30)
Rutgers Launches Fast-Results Saliva Testing For Coronavirus (April 2)
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