What is the SalivaDirect test?
Saliva is now authorized as a reliable tool to detect SARS-Cov-2 .The U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection.
“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game-changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, M.D. “Our current national expansion of COVID-19 testing is only possible because of FDA’s technical expertise and reduction of regulatory barriers, coupled with the private sector’s ability to innovate and their high motivation to answer complex challenges posed by this pandemic.”
Why is this test receiving so much attention?
- Easy-to-collect: This test only requires collection of saliva in a sterile container, as opposed to deep nasal swab (i.e., the nasopharyngeal (NP) swab), which can be uncomfortable for the patient and requires trained personnel wearing special personal protective equipment (PPE) to collect.
- Fewer collection supplies required: Saliva can be collected in sterile containers that are widely available, cheap and do not require special preservatives or containers. In these times, during which supplies are scarce, this is very desirable.
- Fewer steps in testing: Testing for nucleic acids by molecular amplification (i.e., PCR) generally requires the viral RNA to be removed from the specimen and purified. This is called extraction, and the reagents used for extraction have also been in short supply throughout this pandemic. The SalivaDirect test uses a simple procedure that does not require instrumentation to open the virus and remove the viral RNA. This RNA is then tested by molecular amplification.
- Instrument accessibility: Many current SARS-CoV-2 RNA tests are designed to be run on specific instruments, generally made by the manufacturer of the test. The SalivaDirect test can be performed on several types of instruments found in specialized clinical molecular laboratories, potentially allowing those laboratories to start testing without acquiring additional, expensive instruments.
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