PRESS RELEASE:

Saliva Collection Answers Critical Testing Hurdles Enabling Large Scale COVID-19 Testing While Protecting Health Professionals From Exposure

Researchers at Rutgers’ RUCDR Infinite Biologics leverage Spectrum DNA’s SDNA-1000 to confirm saliva matrix as a robust biosample source for successful COVID-19 detection.

Researchers from RUCDR Infinite Biologics at Rutgers University have successfully validated saliva as being a viable biosample source for COVID-19 detection when compared to nasopharyngeal or oropharyngeal swabs. The resourceful discovery has come just in time to answer the consistent exponential increase in test demand.

“This is it. This is what makes America so great,” Said Bill Phillips, Spectrum’s Chief Operating Officer. “Challenge and adversity throw up roadblocks and we partner together to discover, and deliver, not only an answer to the supply shortage for sample collection but uncover a solution that is actually better than what we were using in the first place.”

Saliva testing is a new development that under a medical provider’s direction, allows for simple self-administered sample collection that even those in quarantine or self-isolation can use. Researchers at Rutgers’s RUCDR Infinite Biologics compared swab-collected biosamples head-to-head against saliva biosamples using the Spectrum DNA whole saliva collection device and its patented blue preservation solution. Saliva not only demonstrated to be a robust source of viral RNA but when preserved with Spectrum’s patented preservation solution it was seen 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. Adding in the capability for self-collection uncovers additional opportunity to protect medical teams helping to reduce the risk of further exposure and spread, as opposed to nasal swab biosample collection requiring up close medical assistance.

“It had been previously reported on how saliva was being successfully used for viral DNA/RNA extraction. Due to this state of emergency and medical supply shortage we decided to test it for ourselves using Spectrum saliva collection devices. Our side-by-side test comparison of over 75 patient samples demonstrated that the use of saliva to extract viral RNA was in fact a robust source for COVID-19 detection and equal in performance to the authorized swab-based collection samples,” said Andrew Brooks, PhD COO, RUCDR Infinite Biologics and Professor of Genetics at Rutgers University. “In addition, the preservation solution from the Spectrum whole saliva collection device preserved the COVID-19 viral RNA for testing enabling for easier logistics from sample collection to the testing laboratory.”

“As demand for COVID-19 testing continues to dramatically climb, supplies for many of the critical components are just not keeping pace. The discovery that saliva is a viable and more convenient source of biomaterial for testing will immediately help hospital networks and labs bypassing the critical shortage of supplies including nasal and throat swabs for COVID-19 testing,” said Stephen J. Fanning, CEO of Spectrum Solutions. “A saliva test will also allow for a broad and more expansive population screening for the virus than what has been possible to date during this global health crisis.”

These exciting results have a tremendous impact on testing. We encourage any clinical laboratory or reference laboratory wanting to validate our protocols and submit for their EUA testing authorization to contact Spectrum for guidance. The more of us authorized for testing, the faster we can deliver testing relief to those desperately waiting for answers,” said Dr. Brooks.

RUCDR is currently testing for COVID-19 using the Spectrum DNA SDNA-1000 whole saliva collection device leveraging two easily accessible COVID-19 detection assays under EUA from the FDA. Any laboratory with the ability to test for COVID-19 and the willingness to contribute their assistance during this state of emergency can contact Spectrum for access to saliva testing support documentation, approved operating procedures, and protocols required to file a EUA.

Spectrum Solutions COVID-19 Saliva Collection Kit-09

© Spectrum Solutions™ | Photo Credit: Leslie Titus Bryant

Researchers at Rutgers’ RUCDR Infinite Biologics leverage Spectrum DNA’s SDNA-1000 to confirm saliva matrix as a robust biosample source for successful COVID-19 detection.

Researchers from RUCDR Infinite Biologics at Rutgers University have successfully validated saliva as being a viable biosample source for COVID-19 detection when compared to nasopharyngeal or oropharyngeal swabs. The resourceful discovery has come just in time to answer the consistent exponential increase in test demand.

“This is it. This is what makes America so great,” Said Bill Phillips, Spectrum’s Chief Operating Officer. “Challenge and adversity throw up roadblocks and we partner together to discover, and deliver, not only an answer to the supply shortage for sample collection but uncover a solution that is actually better than what we were using in the first place.”

Saliva testing is a new development that under a medical provider’s direction, allows for simple self-administered sample collection that even those in quarantine or self-isolation can use. Researchers at Rutgers’s RUCDR Infinite Biologics compared swab-collected biosamples head-to-head against saliva biosamples using the Spectrum DNA whole saliva collection device and its patented blue preservation solution. Saliva not only demonstrated to be a robust source of viral RNA but when preserved with Spectrum’s patented preservation solution it was seen 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. Adding in the capability for self-collection uncovers additional opportunity to protect medical teams helping to reduce the risk of further exposure and spread, as opposed to nasal swab biosample collection requiring up close medical assistance.

“It had been previously reported on how saliva was being successfully used for viral DNA/RNA extraction. Due to this state of emergency and medical supply shortage we decided to test it for ourselves using Spectrum saliva collection devices. Our side-by-side test comparison of over 75 patient samples demonstrated that the use of saliva to extract viral RNA was in fact a robust source for COVID-19 detection and equal in performance to the approved swab-based collection samples,” said Andrew Brooks, PhD COO, RUCDR Infinite Biologics and Professor of Genetics at Rutgers University. “In addition, the preservation solution from the Spectrum whole saliva collection device preserved the COVID-19 viral RNA for testing enabling for easier logistics from sample collection to the testing laboratory.”

“As demand for COVID-19 testing continues to dramatically climb, supplies for many of the critical components are just not keeping pace. The discovery that saliva is a viable and more convenient source of biomaterial for testing will immediately help hospital networks and labs bypassing the critical shortage of supplies including nasal and throat swabs for COVID-19 testing,” said Stephen J. Fanning, CEO of Spectrum Solutions. “A saliva test will also allow for a broad and more expansive population screening for the virus than what has been possible to date during this global health crisis.”

These exciting results have a tremendous impact on testing. We encourage any clinical laboratory or reference laboratory wanting to validate our protocols and submit for their EUA testing approval to contact Spectrum for guidance. The more of us approved for testing, the faster we can deliver testing relief to those desperately waiting for answers,” said Dr. Brooks.

RUCDR is currently testing for COVID-19 using the Spectrum DNA SDNA-1000 whole saliva collection device leveraging two easily accessible COVID-19 detection assays under EUA from the FDA. Any laboratory with the ability to test for COVID-19 and the willingness to contribute their assistance during this state of emergency can contact Spectrum for access to saliva testing support documentation, approved operating procedures and protocols required to file a EUA.

Spectrum Solutions COVID-19 Saliva Collection Kit-09

© Spectrum Solutions™ | Photo Credit: Leslie Titus Bryant

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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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