Saliva Transport Stability:

SDNA-1000 Post-Collection Saliva Sample Viability and Stability

NEW EUA MESSAGE SDNA-1000Saliva has not only been demonstrated to be a robust source of viral RNA but when preserved with Spectrum’s patented preservation solution it has been proven to protect COVID-19 transcripts for an extended period of time, making sample collection and transport to CLIA testing labs more efficient and amenable to global testing.

  • The FDA specifies the SDNA-1000 as the ONLY device that is currently authorized for saliva collection for COVID-19 testing.
    • “Saliva specimens must be collected, transported, and stored using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.
  • Rutgers’ Study proved that saliva samples can be shipped and stored at ambient temperatures with no degradation in quality.
    • To support home use of the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device, a Simulated Shipping Study was performed that was designed to evaluate the effect of temperature variation on the stability of SARS-CoV-2 RNA during transport of saliva specimens.
    • The study was conducted using residual clinical specimens that had previously been reported as SARS-CoV-2 positive or negative and stored at -80°C until the start of the study. The SARS-CoV-2 positive specimens were selected based on the Ct values obtained upon initial testing and covered the spectrum of Ct values observed with the assay.
    • The specimens were thawed and then subjected to various thermal profiles which were intended to simulate the extreme temperature conditions that may be experienced in the shipment of specimens during the summer and winter.
    • At the conclusion of each thermal profile, the samples were retested with the Rutgers TaqPath SARS-CoV-2 Assay and the results were compared to those reported upon initial testing at the time the specimens were received.
    • Nineteen out of 20 Low Positive samples (95%) and 10/10 High Positive samples were reported as positive after exposure to the summer and winter temperature excursions.
    • The mean and standard deviation of the Ct values for each gene target was similar before and after simulated shipping, with no evidence of significant degradation of the SARS-CoV-2 RNA.
    • All SARS-CoV-2 negative specimens were reported as “negative.”
    • These results demonstrate that SARS-CoV-2 RNA positive saliva specimens are stable in the SDNA-1000 Saliva Collection Device when exposed to a broad range of temperature conditions.
    • These data support the use of the SDNA-1000 Saliva Collection Device for transport and storage of specimens following home collection of saliva.
  • The SDNA-1000 easily displayed its might in shipping simulations at extreme temperatures for over 10 days with no degradation of sample efficacy, proving sample stability and integrity.

Health is a dynamic state of wellbeing. Healthcare providers and researchers have long believed that changes in our saliva record our ongoing state-of-health story. This encrypted source of individual truth, and how to best use it, delivers us all a quicker path to informed decisions and treatments free of adverse reactions.

Interestingly, saliva acts as a wide resource of genomic information useful for identifying and monitoring in real-time a disease as well as its state of progression. Saliva analysis looks at the cellular level, the biologically active compounds, making it a true representative of what is clinically relevant.

Spectrum’s technically-superior saliva collection systems have not only been engineered to lead the saliva collection industry in molecular diagnostics and clinical research applications but deliver the safest, most robust biomaterial for the earliest detection and diagnosis of disease and infection.

  • Saliva provides the earliest path to critical detection and diagnosis
  • Saliva contains the entire library of proteins, hormones, antibodies, and other molecular compounds measured in routine blood tests
  • First EUA authorized saliva collection device for COVID-19 testing & authorized device for direct-to-patient at-home sample self-collection
  • Used in supervised & unsupervised sample collection LDT workflows of symptomatic & asymptomatic users
  • Pain-free, non-invasive, & safe – ideal for those needing frequent & repeat testing
  • In-device live virus inactivation at ambient temps (COVID-19 EUA validated data)
  • Eliminates hooded containment of samples arriving at the testing lab
  • No temperature-controlled storage or transport of collected saliva samples
  • Single device for DNA & viral RNA applications
  • Safest collection approach & most robust biomaterial for detecting COVID-19
  • Delivers 99.998% highest levels of testing accuracy & sensitivity
  • Formulation identifies infections at its earliest stage from as few as 200 copies/ml (lateral flow rapid tests need 10,000-20,000 copies/ml)
  • A single preserved saliva sample provides opportunity for multiple tests
  • Over two weeks of post-collection stability with no degradation in sample efficacy
  • System maintains critical bio-sample consistency
  • Mass-testing scalability & easy device integration using validated and supported processes
  • Mitigates any risk of infection throughout the testing process
  • Pinpoint life-cycle stage of active viral infection
  • Eliminates UN3373 shipping designation with clearance from USPS, FedEx, & UPS
  • Delivers the highest levels of testing accuracy using qualified extraction chemistries

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