Breakthrough Saliva Transport Discovery:

SDNA-1000 Saliva Sample Transport Viability

Saliva 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 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 were 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 up to about 10 days, proving the sample stability and integrity.

 

Download FDA Report

Spectrum
in the News

Spectrum
in the News

About the Product

Innovative Engineering
SDNA-1000

Open-blister-pack-spectrum-saliva-dna-collection-device

Spectrum Solutions has manufactured over 10 million Saliva Collection devices for distribution worldwide. The SDNA-1000 Saliva Collection Device is Spectrum’s latest device, which will help to lead the saliva collection market in molecular and other diagnostic applications. This fit-for-purpose and technically superior whole saliva collection device has been engineered to reduce self-collection error, is bacteriostatic, and delivers the consistent high-quality, high-yield samples for any medical diagnostic or clinical research required application. The patented preservation solution stabilizes viral samples within the saliva matrix effectively reducing additional exposure-risks to health professionals. As a result, ensuring sample stability at a variety of temperatures that enable the primary sample to be shipped as well as easily stored in case repeat testing is required.

Now available and currently being used as a biosample collection option for viral DNA/RNA COVID-19 testing for hospital networks, health departments, and clinical research organizations ready to accept tens of thousands of samples per day for SARS-CoV-2 coronavirus testing and analysis. Spectrum does its product manufacturing of the SDNA-1000 saliva collection device in-house at their facility in Salt Lake City with the capacity, and proven scalability to meet the rapid growing need for COVID-19 testing devices.

Questions? Let’s Connect