Rutgers Home Saliva Test for Coronavirus Approved

The 1st diagnostic coronavirus test with the option of using home-collected saliva samples has been approved by the U.S. Food and Drug Administration (FDA).

On May 7, 2020, the FDA issued an emergency use authorization to New Jersey-based Rutgers University Clinical Genomics Laboratory for their COVID-19 laboratory-developed test.

The Rutgers at-home saliva self-collection assay, developed by RUCDR in partnership with Spectrum Solutions and Accurate Diagnostic Labs, allows for broader screening than through the standard method using nose and throat swabs at testing locations requiring physical interactions with a healthcare professional.

TaqPath SARS-CoV-2 Assay is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal, nasopharyngeal, anterior nasal, and mid-turbinate nasal swab, as well as saliva specimens from individuals suspected of COVID-19 infection.

It is important to note that this FDA notice is not a general authorization for at-home collection of patient samples using other collection methods, saliva collection devices, or tests, or for tests fully conducted at home.

Rutgers originally received the FDA’s permission on April 23, 2020, to collect saliva samples from patients at test sites, but can now sell the collection kits for individuals to use at home.

Rutgers said it has’ 75,000 of the saliva test kits ready to ship and can process 20,000 tests each day, with a 48-hour turnaround.’

“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D., in a press statement.

“This (test) 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.”

As of May 9, 2020, all 50 states, the District of Columbia, and certain U.S. Territories have successfully verified COVID-19 diagnostic tests and are offered by 245 testing services.

The FDA is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. 

Precision Vaccinations publishes coronavirus test news.