U.S. FDA authorizes first at-home saliva test for COVID-19

U.S. FDA authorizes first at-home saliva test for COVID-19”

Rutgers University's RUCDR Infinite Biologics lab received an amended emergency authorization late Thursday.

A patient collects a saliva sample using the self-collection kit and sends it for testing to the Rutgers lab, now the only site that uses saliva samples to test for SARS-CoV-2, the coronavirus that causes Covid-19, the FDA said.

The Food and Drug Administration said Friday that it had granted emergency authorization for the first at-home saliva collection kit to test for the coronavirus.

Murphy announced on that day that the test would be administered to 1,250 residents and 4,300 staff at five developmental centers across the state.

Rutgers University and its collaborators have developed an approach that uses saliva as the primary test biomaterial for SARS-CoV2.

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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.

During public health emergencies, the FDA can use an EUA to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat or prevent serious or life-threatening diseases upon meeting certain criteria, the federal agency says. Initially, the government limited the test to health care facilities and testing sites with professional supervision.

The recently expanded list of COVID-19 symptoms are cough, difficulty breathing, fever, chills, repeated shaking with chills, headache, sore throat, muscle pain and loss of taste or smell. Because the infection can take several days to develop, they said, the time lag could result in some people receiving false negative test results for coronavirus.

The RUCDR lab has also launched a genetic testing service. "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 are committed to providing this initial wave of testing kits to physicians, laboratory experts and researchers worldwide to enable them to assist frontline workers leading the charge against this pandemic".

"That will be a huge welcome relief to those who have had to go through the process of getting that thing stuck up their nose into the front lobe of their brain", Murphy said of the saliva test. "We will help them find the answer fast", said Jason Feldman, CEO, Vault Health.

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