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Tags: coronavirus | home test | fda | covid19

FDA Grants Approval for First At-Home Saliva Coronavirus Test

FDA Grants Approval for First At-Home Saliva Coronavirus Test

A man is tested for COVID-19 by the San Antonio Fire Department at a free walk-up test site. (Eric Gay/AP)

By    |   Saturday, 09 May 2020 10:04 AM EDT

The U.S. Food and Drug Administration on Friday authorized emergency use for an at-home, saliva coronavirus test, according to the agency's website.

The RUCDR Infinite Biologics lab at Rutgers University got an amended emergency authorization on Thursday for the test, which lets people send saliva samples to a lab.

The same lab was also granted emergency authorization in April for its saliva collection method, which New Jersey health care workers used to begin testing patients, according to The New York Times.

The FDA made note that this would be the only saliva-based coronavirus testing kit on the market. The only other coronavirus tests require people to gather nasal or throat samples and send them to a lab.

"What's new and next is expanding access to testing for people," chief operating officer and director of technology development at the RUCDR Infinite Biologics lab Andrew Brooks told CNN.

According to Brooks, users will have to spit into a tube and fasten it with a cap. When the entire preservation agent turns blue, the tube is placed into a biohazard bag and sent off to the lab.

"If people are committed to do self-collection and can facilitate that collection at home, certainly with a prescription under medical care, we can get to those that are quarantined, don't have the means for transportation or are too scared to go outside," Brooks said. "So they get the test in the mail or from a distribution center."

FDA Commissioner Dr. Stephen M. Hahn wrote in the agency's press release: "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."

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US
The U.S. Food and Drug Administration on Friday authorized emergency use for an at-home, saliva coronavirus test, according to the agency's website.
coronavirus, home test, fda, covid19
284
2020-04-09
Saturday, 09 May 2020 10:04 AM
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