SalivaDirect™ Testing Services
SalivaDirect™ is a saliva-based PCR testing protocol for the detection of SARS-CoV-2. It is an open-source protocol that is highly sensitive, cost-effective and can be used with several interchangeable reagents and instruments.
Developed by the Yale School of Public Health (YSPH), the SalivaDirect™ protocol:
- Uses self-collected saliva, not nasal swabs;
- Has sensitivity and accuracy comparable to the CDC’s PCR test with RNA-extraction;
- Reduces the risk of transmission among healthcare workers;
- Is cost effective ($1-4/sample in reagents and consumables, excluding labor and overhead);
- Allows a single lab technician to manually run 93 samples in 3-4 hours (this throughput can increase if pooled or automated workflows are in place); and
- Is easily implemented in CLIA laboratories under the SalivaDirect™ Emergency Use Authorization (EUA)*, with minimal in-house validation and no direct interaction with the FDA.
(* EUA indication is for single-test and pooled testing protocols (up to 5 individuals) for individuals suspected of COVID-19 by their healthcare provider or for those without symptoms.)
SalivaDirect™ is offered by designated, high complexity CLIA certified labs. With its growing lab network SalivaDirect™, can help you to find a lab that offers its protocol.
You can find a designated lab to conduct your test by consulting the SalivaDirect™ list of designated laboratories.
Collection Method/Analysis Location: On-site self-collection for age 18+ or collection by an adult trained to collect saliva samples.
CLIA Certification: Designated laboratories are covered by the SalivaDirect™ EUA.
Sample: Saliva
Time to Results: Results within 3-4 hours upon receipt by laboratory
What’s in each test kit: (sent by designated lab chosen by customer)
Test kit contents will differ by type of test requested by customer from designated lab:
- The Unsupervised Option
- SalivaDirect™ At-Home Collection Kit for symptomatic or asymptomatic COVID-19 testing in ages 18+