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APC Health significantly expands SalivaDirect™ saliva-based COVID-19 PCR testing capacity

Game-changing test developed by Yale School of Public Health offers ease of collection, accuracy, and rapid turnaround at lower cost.

HOUSTON, TEXAS, USA, January 4, 2021 /EINPresswire.com/ -- APC Health is pleased to announce that it has significantly increased capacity for the SalivaDirect™ SARS-CoV-2 test. SalivaDirectTM, a new COVID-19 test ideal for large-scale testing developed by Yale School of Public Health, offers many advantages over traditional testing methods. SalivaDirect™ uses a high-complexity protocol that requires a certified laboratory and trained technicians to conduct the testing.

SalivaDirect™ is a real-time reverse transcription-polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2. It provides analytical sensitivity of 95%, and specificity of 100%. Unlike traditional tests, it uses saliva rather than uncomfortable and invasive nasopharyngeal swabs. Benefits of SalivaDirect™ include accuracy, patient comfort, ease and speed of collection, rapid turn-around, and no requirement for a special collection kit, making it more cost-effective and scalable.

“In response to the continued need for more high-quality, cost effective and scalable SARS-CoV-2 PCR testing we have substantially increased capacity for SalivaDirect™ testing at our lab in Pearland, Texas. By validating additional instrumentation, optimizing workflows and moving to a 7-day a week schedule we continue to increase access to highly accurate, cost-effective, and scalable testing for SARS-CoV-2 in our community. Our team is consistently delivering results within 12-48 hours of receiving samples and we are committed to providing a better alternative to existing invasive, high-cost COVID-19 testing,” says Rohan Nath, Founder and CEO of APC Health.

APC Health, recognizing the benefits of SalivaDirect™ compared to traditional tests using nasopharyngeal swabs, completed a rigorous validation process to offer this ground-breaking test and signed an agreement with the Yale School of Public Health on October 30, 2020, to provide the test. Since then the Pearland, Texas-based lab has performed thousands of SalivaDirect™ tests for urgent care clinics, senior living facilities, medical practices, and universities.

The SalivaDirect™ test is available now from APC Health LLC. For more information on how to start using SalivaDirectTM at your location, email info@apchealth.net or visit https://apchealth.net.

About APC Health LLC (https://apchealth.net):
APC Health is a CLIA certified high-complexity diagnostic laboratory specializing in PCR-based molecular testing for the detection of viruses, including Influenza A/B, COVID-19, STI, women’s health, and UTIs. Founded in 2015, the privately-owned company is in-network with most leading healthcare insurance companies.

About SalivaDirectTM (https://publichealth.yale.edu/salivadirect/):
SalivaDirectTM has not been FDA cleared or approved. The FDA authorized the test under an emergency use authorization (EUA) for use by authorized laboratories on August 15, 2020. 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.

Rohan Nath
APC Health LLC
+1 713-772-2132
rnath@apchealth.net