Papers & Protocols
For diagnostic and screening purposes, only labs designated by Yale and that follow the Instructions For Use, which we will provide, can use SalivaDirect. For research purposes, our open-source protocol can be used.
Other Research Protocols
We have made other protocols available for SARS-CoV-2 research, such as saliva collection, RNA extraction, and development of positive control standards.
- SalivaDirect: A Simplified and Flexible Platform to Enhance SARS-CoV-2 Testing Capacity
SalivaDirect™: Simple and sensitive molecular diagnostic test for SARS-CoV-2 surveillance
Simply saliva: stability of SARS-CoV-2 detection negates the need for expensive collection devices
Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2
Analytical sensitivity and efficiency comparisons of SARS-CoV-2 RT–qPCR primer–probe sets
- Detection of SARS-CoV-2 RNA by multiplex RT-qPCR
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.