FDA Approves First At-Home Coronavirus Saliva Collection Test

Carly Baldwin
·4 min read

PISCATAWAY, NJ — In the future, if you want to be tested for the coronavirus, you may not have to venture too far from the safety of your own home.

That's because this week the Food and Drug Administration granted an emergency-use authorization to Rutgers' RUCDR Infinite Biologics for at-home use of its coronavirus saliva test.

As Patch reported, Infinite Biologics invented the now-famous "coronavirus spit test," which uses patients' saliva samples to test for the virus instead of a painful upper nasal swab. You spit into a test tube, seal it and the saliva samples are tested at the Infinite Biologics lab in Piscataway. Test results are usually returned within 24 hours.

The FDA just granted emergency in-home use of the test kits late Thursday. Infinite Biologics partnered with Vault Health to deliver the test.

One has to get the saliva test through a doctor, said Rutgers spokesman Todd Bates. You can order the saliva test kits online here: https://www.vaulthealth.com/covid and consult with a doctor via telehealth before the test is mailed to you. The test kit is $150 and it is not known if they are covered by insurance.

This is the first SARS-CoV-2 coronavirus test kit in the world that will allow people to collect their own saliva at home.

Middlesex County residents who've used the saliva test report positive results.

"I was tested at the South Brunswick site and my husband was tested at the Edison site," said Middlesex County resident Rachel Skvasik. "Both of our experiences were very easy and straightforward. We barely waited and it seemed like a very smooth process. I was tested on a Thursday and received a phone call with my results on Monday. My husband was tested this past Monday and he received a call with his results on Wednesday."

She was not surprised by her positive result: She had a fever, fatigue, headache, stomach issues, dizziness and a loss of smell/taste. Her husband's test came back negative. However, his symptoms were much milder and he also felt ill three weeks prior to being tested, she said.

"We believe my husband had it before me," she said.

Spit test is faster, much less painful than nasal swab

The Rutgers scientists who developed the coronavirus spit test say it is much less painful and invasive than a nasal swab, and test results are much faster, usually available within 24 to 48 hours. Also, because the saliva tests can be processed more quickly, more people can be tested — potentially up to 10,000 per day.

“Not only do we no longer have to put healthcare professionals at risk, but it will enable testing for people who do not have the means to get to a collection center,” said Andrew Brooks, director of technology development at RUCDR Infinite Biologics.

Brooks is also a genetics professor at Rutgers.

"And we can now preserve precious personal protective equipment for use in patient care instead of testing, and can significantly increase the number of people (tested) every day."

RUCDR Infinite Biologics says it is the world's largest university-based cell and DNA repository. It is part of the Rutgers' Human Genetics Institute.

A history of Rutgers' coronavirus saliva tests

As Patch reported, Rutgers Infinite Biologics developed the COVID spit test in March of this year, and the tests were first unveiled April 2.

However, because the tests initially 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.

Then in mid-April the FDA granted what's known as "emergency use authorization" to give the saliva tests to the general public. The same day the FDA approved them, Brooks said he received a call from the White House's COVID-19 task force offering congratulations and asking how they could expand the saliva testing nationwide.

On April 13, the saliva tests started being offered to the general public at the Edison Motor Vehicle test site on Kilmer Road, the first time anywhere in the U.S. they were publicly available. The site so far has tested thousands, say officials.

The saliva tests are also now being offered in South Brunswick, New Brunswick, Keyport, Freehold and Red Bank through the Visiting Nurse Association of Central Jersey (you must have symptoms to be tested, or have been in contact with a COVID patient).

Keep reading: Rutgers Launches Fast-Results Saliva Testing For Coronavirus (April 2)

Edison Site First In U.S. To Offer Drive-Thru Coronavirus Saliva Test (April 13)

This article originally appeared on the New Brunswick Patch