SalivaDirect™- Highly Accurate, Non-Invasive Saliva Test Developed by Yale School of Public Health
Arden, N.C. – CommunityLab is pleased to offer non-invasive, saliva-based testing for COVID-19 at its drive-up testing facility located at 2 Trident Dr. in Arden starting on Monday, May 10. Results are available within 24 hours or less. Same-day appointments are available with flexible arrival time blocks open Monday – Saturday between 9 a.m. to 6 p.m.
SalivaDirect™ is a saliva-based method developed at the Yale School of Public Health to test persons suspected of having COVID-19 for the virus, SARS-CoV-2. The method is an RNA extraction-free, real-time reverse transcription-polymerase chain reaction (rRT-PCR) qualitative test for the detection of nucleic acid from SARS-CoV-2. The accuracy of the SalivaDirect™ testing protocol is comparable to nasopharyngeal swab. The test provides analytical sensitivity of 99% and is accurate 94% of the time.
A small saliva sample (at least 0.5 mL) is collected in a sterile container without any expensive preservatives. Compared to swab testing, saliva testing improves patient compliance and ease of use. It is also more comfortable, safer, and quicker to collect than traditional nasopharyngeal swab testing.
CommunityLab completed a rigorous validation process to be approved as a designated lab for SalivaDirect™ and signed an agreement with the Yale School of Public Health on April 13, 2021. Designated labs require trained technicians conduct the testing and select from multiple validated vendors for reagents and instruments. The method is extraction-free, making it cost-effective. No special collection kit is needed which mitigates risk of supply chain shortages. Additionally, the collection procedure is safer in that there is less risk of exposure to healthcare workers collecting the samples.
COVID-19 testing performed at CommunityLab is gold-standard PCR testing and available to anyone regardless of symptoms or known exposure to the SARS-CoV-2 virus. Those interested in testing may choose either saliva-based testing or nasopharyngeal swab collection, based on their preference.
“Saliva-based testing for COVID-19 presents numerous advantages,” said Jade Henson, Community Outreach and Collection Manager at CommunityLab. “Many individuals find nasopharyngeal and mid-turbinate collection intimidating and are reluctant to receive testing. Saliva collection is non-invasive and pain-free, and therefore may appeal to individuals who have previously been hesitant to test. Saliva testing may additionally prove especially beneficial for the pediatric population.”
In addition to its drive-up testing program, CommunityLab partners with local businesses, healthcare providers, healthcare organizations, public institutions, or private corporations of any size. Their team can customize services to meet each organization’s unique needs. For more information on how to partner with CommunityLab for SalivaDirect™ COVID-19 testing, visit www.communitylabwnc.com or email [email protected]
CommunityLab, a division of Sanesco, specializes in molecular and diagnostic laboratory testing. CommunityLab is devoted to improving health, wellness, and quality of life for all people and communities in WNC. The development of CommunityLab and collaboration with the WNC community is driven by the targeted investment and support of Dogwood Health Trust.
Sanesco International Inc. is a global leader providing specialty, neuroendocrine laboratory testing for healthcare providers, hospital networks, reference laboratories, and research partners for over a decade. Sanesco’s high-complexity, CLIA-certified clinical laboratory has tested hundreds of thousands of patients, amassing one of the largest repositories of human stress response data. Most importantly, Sanesco is driven by its mission to improve quality of life.
SalivaDirect™ was issued an Emergency Use Authorization (EUA) from the US Food and Drug Administration for use by authorized high-complexity, CLIA-certified laboratories under EUA 202097. SalivaDirect™ has not been FDA cleared or approved. 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.