Today’s EUA for Rutgers Clinical Genomics Laboratory’s molecular test permits testing of a saliva sample collected from the patient using a designated self-collection kit. Once patients collect their saliva sample, they return it to the Rutgers Clinical Genomics Laboratory in a sealed package for testing.
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 test remains prescription only.
Today’s authorization is limited to testing performed at the Rutgers Clinical Genomics Laboratory using their molecular LDT COVID-19 authorized test for saliva specimens collected using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. It is important to note that this 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.
The FDA, 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. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
© Spectrum Solutions™ Saliva Collection Device | Photo Credit: Leslie Titus Bryant