FDA authorizes first at-home saliva test for COVID-19
May 11 2020
His lab can process 20,000 tests each day, with a 48-hour turnaround, but he expects other labs to adopt it for their own use. Once patients collect their saliva sample, they return it to the lab in a sealed package for testing, the FDA added.
US health regulators approved the first saliva-based coronavirus test that allows people to collect their own sample at home. It will also allow people who can not leave their home because they are too sick or in quarantine to get tested.
Rutgers University received the federal go-ahead for an at-home, self-administered version of its COVID-19 saliva test, which Gov. Phil Murphy has argued could be integral to dramatically scaling up the state's testing capabilities.
Brooks said the tests should be used only by people who have COVID-19 symptoms.
The spit test, developed by Rutgers University, is the only authorized saliva-based COVID-19 test available, according to the FDA. When the entire preservation agent turns blue, the tube is placed into a biohazard bag and sent off to the lab.
"This will enable testing for people that do not have the means to get to a collection center and ... are at home because they are sick, quarantined, at increased risk for infection or simply concerned about exposing themselves by traveling to a collection site", Brooks added.
Now, the amended authorization will allow people to collect their own saliva at home and avoid potentially risky contact with people at testing sites. Beyond the rapid, accurate and broad testing for COVID-19 that is critically necessary, this test has other crucial benefits: it expands the availability of testing across the US, decreases the risk to medical professionals who are now directly exposed to the virus when performing a nasal swab-based sample collection, and preserves precious personal protective equipment (PPE) which is in limited supply.
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.
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 test remains prescription only.