ADVAITE's High Complexity CLIA Lab Receives Authorization from Yale University to Offer Highly Accurate COVID-19 SalivaDirect™ Test
CHICAGO, Nov. 11, 2020 /PRNewswire/ -- ADVAITE Inc., a biotech at the forefront of the COVID-19 pandemic response, announces that the company's high complexity CLIA laboratory operating out of Chicago, IL has been authorized to offer Yale University's SalivaDirect™ test. SalivaDirect™ is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect™ was developed by the Yale School of Public Health (YSPH) and has received an Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA). The FDA limits the emergency use of SalivaDirect™ testing only to high-complexity CLIA-certified laboratories, such as ADVAITE's Chicago Laboratory, which have been formally designated as authorized laboratories by YSPH under the EUA 202097.
SalivaDirect™ provides analytical sensitivity of 99%, and specificity of 94%, establishing it as one of the gold standards for COVID-19 testing. The method has several unique differences compared to traditional PCR (polymerase chain reaction) methods, including (i) the use of saliva instead of the more invasive nasopharyngeal swab, and (ii) the lack of an additional nucleic acid extraction step, which can save valuable time when processing samples.
In a spring 2020 pilot program led by the Yale School of Public Health, the National Basketball Association (NBA), and the National Basketball Players Association (NBPA), SalivaDirect™ was successfully used to test asymptomatic people within the NBA and NBPA communities throughout the completion of the basketball season.
"The SalivaDirect COVID-19 PCR-based nucleic acid test will allow us to shift away from a defensive symptom-based strategy to a proactive surveillance-based strategy that enables communities and businesses to stay open safely during the pandemic," said Sandeep Jain M.D., Chief Scientific Officer & Co-Founder, ADVAITE Inc. "As an example of success of this strategy, mandatory saliva testing programs are currently being used in public universities to allow safe student and staff participation in campus housing, performing arts and athletics".
The addition of SalivaDirect™ to ADVAITE's existing testing and R&D capabilities uniquely positions the company at the forefront of combatting the ever-growing COVID-19 pandemic.
Other FDA EUA tests offered by the ADVAITE high complexity CLIA laboratory include:
ADVAITE's continued enhancement of its accurate and reliable testing capabilities is critical to the nation-wide effort to contain the spread of this deadly virus as the CDC confirms over 10 million cases of COVID-19 in the U.S. so far.
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SOURCE ADVAITE Inc.