COVID-19 Diagnostic Testing For All - Using Non-Dilutive Saliva Sample Collection, Stabilization and Ambient Transport Devices

Carrington, Y. J.; Orlino, J.; Romero, A.; Gustin, J. R.; Rezaei, M.; Green, E.; Rose, S. L.; Aiyer, R. A.; Nasarabadi, S.

Covid-19 testing is not accessible for millions during this pandemic despite our best efforts. Without greatly expanded testing of asymptomatic individuals, contact tracing and subsequent isolation of spreaders remains unobtainable as a means for control. In an effort to increase RT-PCR assay testing for the presence of the novel beta-coronavirus SARS-CoV-2 as well as improve sample collection safety, GenTegra LLC has introduced two products for saliva collection and viral RNA stabilization: GTR-STM (GenTegra Saliva Transport Medium) and GTR-STMdk (GenTegra Saliva Transport Medium Direct to PCR). Both products contain a proprietary formulation based on GenTegra's novel "Active Chemical ProtectionTM" (ACP) technology that gives non-dilutive, error-free saliva sample collection using RNA stabilization chemicals already dried in the collection tube. GTR-STM can be used for safer saliva-based sample collection at home (or at a test site). Following saliva collection, the sample-containing GTR-STM can be kept at ambient temperature during shipment to an authorized CLIA lab for analysis. SARS-CoV-2 viral RNA in GTR-STM is stable for over a month at ambient temperature, easily surviving the longest transit times from home to lab. GTR-STM enhances patient comfort, convenience, compliance and reduces infectious virus exposure to essential medical and lab professionals. Alternatively, the GTR-STMdk direct-into-PCR product can be used to improve lab throughput and reduce reagent costs for saliva sample collection and testing at any lab site with access to refrigeration. GTR-STMdk reduces lab process time by 25% and reagent costs by 30% compared to other approaches. Since GTR-STMdk retains SARS-CoV-2 viral RNA stability for three days at ambient temperature, it is optimized for lab test site rather than at home saliva collection. SARS-COV-2 viral RNA levels as low as 0.4 genome equivalents/uL are detected in saliva samples using GTR-STMdk. This increased sensitivity of SARS-CoV-2 detection can expand Covid-19 testing to include asymptomatic individuals using pooled saliva. The formal Limit of Detection (LoD) of SARS-CoV-2 in GTR-STM and GTR-STMdk in human saliva in individual and pooled samples will shortly be known.