FDA authorizes Rutgers University's first at-home COVID-19 saliva test
The US Food and Drug Administration on Friday issued an emergency use authorization for the first at-home COVID-19 test that uses saliva samples, the agency said in a news release.
Rutgers University's RUCDR Infinite Biologics lab received an amended emergency authorization late Thursday. With the test, people can collect their own saliva at home and send their saliva samples to a lab for results.
Testing for Covid-19 so far has usually involved nose or throat swab samples.
In April, Rutgers University announced that the FDA authorized the saliva test that it developed with other groups for "emergency use" for diagnosing Covid-19.
"What's new and next is expanding access to testing for people," Andrew Brooks, chief operating officer and director of technology development at the RUCDR Infinite Biologics lab, told CNN.
"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."
Brooks said the test includes instructions on how to spit into a funnel to collect a saliva sample and seal with a cap to preserve the sample. A preservation agent will appear, blue in color, and once the whole sample is blue, it's put back in a biohazard bag provided with the kit and sent to a lab for testing.
"Authorizing additional diagnostic tests with the option of at-home sample collection will continue to 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," FDA Commissioner Dr. Stephen M. Hahn said in the FDA's press release on Friday.
"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. "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."
The FDA noted in its release that the Rutgers test is currently the only authorized Covid-19 diagnostic test that uses saliva samples to test for the novel coronavirus. The test remains prescription only.
Another prescription-only test kit, made by LabCorp, received FDA authorization in April and allows patients to collect their own samples by nasal swab and send to a lab for testing.
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