FDA authorizes first in-home salvia-based test for COVID-19

Coronavirus

FILE – This undated electron microscope image made available by the U.S. National Institutes of Health in February 2020 shows the Novel Coronavirus SARS-CoV-2. Also known as 2019-nCoV, the virus causes COVID-19. The sample was isolated from a patient in the U.S. On Tuesday, April 21, 2020, U.S. health regulators OK’d the first coronavirus test that allows people to collect their own sample at home, a new approach that could help expand testing options in most states. The sample will still have to be shipped for processing back to LabCorp, which operates diagnostic labs throughout the U.S. (NIAID-RML via AP)

(WRIC) — The U.S. Food and Drug Administration said on Friday that it has issued an emergency authorization for a diagnostic test that allows patients to collect saliva samples at home for COVID-19 testing.

The announcement comes after April’s emergency authorization for the first diagnostic test with a home-collection option, which uses a sample collected from the patient’s nose with a nasal swab and saline, a solution of salt and water.

According to a release, the authorization extends to the Rutgers Clinical Genomics Laboratory for their COVID-19 lab-developed test. Once a saliva sample is collected, patients ship the self-collection kit to the Rutgers Clinical Genomics Laboratory in a sealed package 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,” said FDA Commissioner Stephen M. Hahn, M.D. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. 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 Rutgers Clinical Genomics Laboratory test is currently the only authorized COVID-19 diagnostic test that uses saliva samples to test for SARS-CoV-2, the strain of coronavirus that causes COVID-19, the release added.

The test remains prescription only.

Click here to read the FDA’s full announcement.

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