Novel SARS CoV-2 Saliva Collection Devices Improve Lab Efficiency and PCR Test Performance

Direct-into-PCR, GTR-STMdk eliminates the need for expensive and time consuming RNA extraction, improving the turnaround time for reporting test results. The two novel products are available to CLIA certified laboratories and IVD assay kit manufacturers pursuant to regulatory approvals in their respective US FDA Emergency User Authorization (EUA) protocols.

The dried transport media formulation in both of these devices incorporates the company’s Active Chemical Protection (ACP) technology to provide substantial improvements in SARS-CoV-2 viral RNA stability, and RT-PCR process efficiency for COVID-19 saliva testing. The company’s ACP technology incorporates a proprietary combination of small molecule inhibitors, antioxidants, metal chelators, and anti-microbials to provide total protection for SARS-CoV-2 virus and viral RNA at ambient temperatures. Proprietary ACP chemistry reduces saliva viscosity, inactivates contaminating RNases, and bacteria, and facilitates sterilization of samples at 95C making the sample safe for lab personnel and testing. ACP chemistry is guanidinium free making it compatible with lab automation and self-sterilizing PCR instrumentation.

“By creating a dry transport media formulation of our proven ACP technology, we have eliminated many of the risks and error prone steps involved with current COVID-19 saliva collection products,” said GenTegra President Bob Barrett. “Most importantly, eliminating the addition of a liquid sample stabilizer may improve low copy number detection, and may address some of the concerns of potential false negatives due to sample dilution. This may be especially true when testing asymptomatic populations where viral load in saliva may be low and when multiple samples are pooled for greater testing efficiency.”

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GenTegra, LLC