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FDA authorizes first at-home COVID-19 diagnostic test using saliva specimens

Food and Drug Administration

The U.S. Food and Drug Administration has authorized the first coronavirus test using at-home collection of saliva samples

11 May 2020
Tom Casburn
Associate Editor

Industry news

The U.S. Food and Drug Administration has authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. The FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which had been previously added to the high complexity molecular-based LDT “umbrella” EUA, to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. This announcement builds on last month’s EUA 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.

“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 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.

The 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.

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ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. Molecular DiagnosticsMolecular diagnostics use an individual’s genetic code and gene expression to diagnose and monitor diseases. The technique is used increasingly in the field of infectious diseases and oncology, as well as areas such as coagulation, HLA typing and pharmacogenomics. Molecular diagnostics plays a pivotal role in personalized medicine.CoronavirusCoronaviruses are a large family of viruses that can cause illnesses ranging from the common cold to more severe diseases like COVID-19. Research into the biology, transmission, and treatment of coronaviruses has become a global priority, particularly since the emergence of SARS-CoV-2. Understanding the virus�s structure and behavior is essential for developing vaccines, diagnostics, and antiviral treatments. Explore our peer-reviewed product directory to discover the latest research tools, diagnostic tests, vaccines, and treatments for coronavirus, compare products, read reviews, and receive pricing directly from manufacturers.Covid-19COVID-19, caused by the SARS-CoV-2 virus, has led to a global health crisis with profound impacts on societies and economies. Research into diagnostics, vaccines, treatments, and understanding viral mechanisms continues to evolve. The pandemic has accelerated innovations in healthcare and biopharmaceuticals, including novel vaccine platforms and rapid testing technologies. Browse our peer-reviewed product directory to find top COVID-19 testing kits, research tools, vaccines, and treatments, compare products, read reviews, and receive direct pricing from manufacturers.

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