US FDA approves home-collected saliva test for coronavirus

US FDA approves home-collected saliva test for coronavirus”

USA health regulators approved the first saliva-based coronavirus test that allows people to collect their own sample at home. Once patients collect their saliva sample, they return it to the lab in a sealed package for testing, the FDA added.

Last month, the FDA approved the first at-home test which used samples collected from the patient's nose with a nasal swab and saline.

The FDA noted in its release that the Rutgers test is now the only authorized Covid-19 diagnostic test that uses saliva samples to test for the novel coronavirus.

Like swab tests, however, the saliva-based test relies on PCR machines to process sampled genetic material; specific chemical reagents are needed to run the machines and could present supply chain problems, Angela Rasmussen, a virologist at Columbia University, told the Times.

"The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency", Hahn added.

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.

More news: Coronavirus deaths in Italy up 274, No of infected down 1,904

The medically supervised saliva collection test for COVID-19 is more sensitive and safer than the existing swab test, and is performed under the supervision of a Vault healthcare provider through a video telehealth visit, eliminating the risk of person-to-person exposure to the virus. "Twenty-four to 48 hours later, you get your test results".

The expanded FDA approval will permit testing of people who can not 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.

The test is by prescription only.

"We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic", Hahn said.

This story was first published on, "FDA authorizes the first at-home Covid-19 saliva test". In April, the lab received emergency use authorization for their saliva collection method, which allowed health care workers to begin testing New Jersey residents at select sites throughout the state, The New York Times reported April 29.

On April 20, the FDA authorised one of the largest private U.S. laboratory chains, LabCorp, to analyse nasal samples collected by patients at home.

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