Officials with the FDA granted Emergency Use Authorization (EUA) to the first diagnostic test that will allow at-home collection of saliva samples for coronavirus disease 2019 (COVID-19) testing.
Officials with the FDA granted Emergency Use Authorization (EUA) to the first diagnostic test that will allow at-home collection of saliva samples for coronavirus disease 2019 (COVID-19) testing, according to a press release.
Rutgers RUCDR Infinite Biologics’ COVID-19 test received the amended EUA for at-home use, which follows the FDA’s recent decision to grant emergency approval to the saliva-based test for use by health care workers at testing sites. The new at-home self-collection assay was developed by RUCDR in partnership with Spectrum Solutions and Accurate Diagnostic Labs.
“The impact of this approval means that not only do we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections, we can now preserve precious [personal protective equipment] for use in patient care instead of testing and can significantly increase the number of people collected each and every day in places other than a health care setting,” Andrew Brooks, chief operating officer and director of technology development at RUCDR, who is also a professor in the Schools of Arts and Sciences Department of Genetics and Rutgers University, said in a statement.
The test utilizes saliva as the primary test biomaterial for the virus. The new method will allow for broader population screening, as current COVID-19 tests utilize nose and throat swabs. Moreover, the new testing method will not require health care professionals to be put at risk to collect samples.
With today’s EUA, patients will be able to perform at-home collection of saliva samples using a designation self-collection kit, which will then be returned to the Rutgers Clinical Genomics Laboratory in a sealed package for testing, according to the FDA.
“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19,” FDA Commissioner Stephen M. Hahn, MD, said in a statement. “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.”
1. FDA Approves First At-Home Saliva Collection Test for Coronavirus. News Release. Rutgers University; May 8, 2020. Accessed May 8, 2020. https://www.rutgers.edu/news/fda-approves-first-home-saliva-collection-test-coronaviruest.
2. Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens. News Release. FDA; May 8, 2020. Accessed May 8, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-diagnostic-test-using-home-collection-saliva