A much-heralded saliva test for the coronavirus developed at a Rutgers University lab has gained federal approval and will allow people to collect their own test samples at home and send them out to be processed.
The Food and Drug Administration late Thursday approved an amended emergency use authorization for Rutgers’ RUCDR Infinite Biologics allows the expansion of the saliva tests well beyond official collection locations.
The home tests are available now, officials said, through a prescription.
“People can get tests through a tele-health provider, a physician, a healthcare network or whoever is supporting the testing,” said Andrew Brooks, chief operating officer and director of technology development at RUCDR.
Unlike a pregnancy test that gives an immediate reading, the saliva samples still need to be processed at a lab. After a spit into a tube, those being tested send their saliva sample to the lab via overnight courier or the US Postal Service, he explained.
“Being able to collect a sample for COVID-19 testing at home will have a major impact in terms of screening,” said Brooks.
The expanded FDA approval will permit testing of people who cannot get to a collection center, or who are homebound because they are sick, quarantined, or at increased risk for infection, said Brooks, who is also a professor university’s Department of Genetics.
University officials said home testing will also help the Rutgers community, allowing for more convenient testing of faculty, students and staff when the time comes to reopen the campus.
FDA Commissioner Stephen M. Hahn said the availability of at-home sample collection will increase patient access to testing for COVID-19.
“This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” Hahn said.
RUCDR, which developed the collection method in partnership with Spectrum Solutions and Accurate Diagnostic Labs — along with a new lab system to increase the number of tests that can be done — claims the saliva analysis technology itself will significantly expand the ability to test more people.
The science behind the detection of COVID-19 in saliva testing is the same as conventional swab tests, using molecular analysis in a process known as polymerase chain reaction, or PCR, which amplifies tiny bits of genetic material to pick up the virus.
However, nasal and throat swab tests, which are the currently the primary collection method used for COVID-19 testing, can be uncomfortable or painful, and require trained medical personnel to conduct the tests. That has limited the screening for coronavirus across the country.
So far, the new saliva tests have already been 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. Middlesex County has also been using saliva collection at one of its testing sites.
The saliva tests are already basically self-administered. One simply spits into a tube with a funnel attached, and hands it over for processing. Officials said it not only allows far more collections in an hour, but they are also able to analyze 10,000 samples a day with the opportunity to quickly ramp that up substantially, providing results in 24 to 48 hours.
According to Rutgers, more than 60,000 saliva tests have been performed since the test system was approved last month. Home collection of samples is expected to greatly increase those numbers.
In New Jersey alone, they said thousands of samples a day are already being collected from patients from various entities, including multiple New Jersey county drive-throughs and walk-ups, the state Department of Corrections, the Department of Human Services and long-term care facilities.
Ted Sherman may be reached at firstname.lastname@example.org.