Who is the SalivaDirect™ Team?
The SalivaDirect test was developed by the Yale School of Public Health with a mission:
“To mobilize academic, government, public, and private sectors to ensure the broadest access to affordable and equitable SARS-CoV-2 testing nationwide.”
Using nasal swabs quickly became the standard for Covid-19 testing in the United States and around the world. Unfortunately, this led to increased demands for nasal swabs that supply couldn’t keep up with. Nasal swabbing also places healthcare workers at risk of contracting the virus from patients when obtaining samples. Finally, many people potentially infected with Covid-19 avoided getting tested due to the difficulty and discomfort of nasal swabbing. All of these factors led the SalivaDirect team to realize that using saliva for testing samples could help overcome all the challenges of nasal swab samples. After research, the team found that not only are saliva samples equally as reliable in detecting Covid-19 as nasal swabs, but saliva samples also detect a higher viral load and can pick up asymptomatic cases.
Learn more on the SalivaDirect™ website.
What is SalivaDirect™ and why should labs become SalivaDirect™ certified?
From the SalivaDirect website, the test is described as
“an Emergency Use Authorized (EUA) PCR test that bypasses the RNA extraction step and uses interchangeable reagents and instruments that are routinely found in clinical labs.”
Features of SalivaDirectTM include:
- Uses self-collected saliva rather than nasal swabs.
- Is equally as sensitive and accurate as the CDC’s PCR test, which includes RNA extraction.
- Helps healthcare workers reduce their risk of contracting Covid-19 from patients.
- Is a very cost-effective option ($1-4/sample in reagents and consumables, excluding labor and overhead).
- Can be easily implemented in CLIA laboratories under the SalivaDirect™ EUA with minimal in-house validation and no direct interaction with the FDA.
- Allows one lab technician to manually run 93 samples in 3-4 hours; this throughput can increase if pooled or automated workflows are in place.
- Is designed and validated to be used with many common and available reagents, meaning new manufacturing is not needed if a reagent must be changed.
- Can be processed using equipment from many major manufacturers.
Because SalivaDirect has received an Emergency Use Authorization from the FDA, its use is limited to laboratories that have been formally designated as authorized laboratories by Yale School of Public Health under the EUA 202097.
How to become SalivaDirect™ certified
Learn more about how to become certified on the SalivaDirect website.