Where is SalivaDirect™?
What is SalivaDirect™?
Regularly testing large numbers of people will play a huge role in monitoring transmission of SARS-CoV-2. Quickly detecting and isolating active cases – people who can transmit the virus, whether symptomatic or asymptomatic – is the cornerstone for limiting disease spread. In addition, accurate data on the number of active cases is necessary to inform policy makers (at local, state, and federal levels) as well as individuals what the short-term risk of spread is and how safe it is to do things like return to workplaces, attend school, and see friends and family.
Ramping up testing for effective SARS-CoV-2 surveillance has faced several barriers. One of those is the reliance on nasopharyngeal swabs, or “NP swabs.” Getting these swabs can be uncomfortable, which discourages people from getting tested frequently. NP swabs also have to be collected by someone who is trained to do so, adding a logistical barrier and putting those performing the test at risk of getting sick. Because SARS-CoV-2 rapidly spread worldwide, it has put immense strain on the supply chains that provide materials for tests, including swabs and test reagents. SalivaDirect is our answer to these problems.
SalivaDirectTM is a new method for testing people suspected of SARS-CoV-2 infection. While it still relies on a similar molecular process as earlier tests (called RT-qPCR), we made it simpler to drive down costs and place less stress on the supply chains.
Important Information about SalivaDirect™
SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.