Breakthrough Saliva Discovery:

Evidence proves saliva a more consistent & sensitive biosample when testing for COVID-19

Saliva is one of our biggest foes in the COVID-19 pandemic, because of its role in spreading the virus. But it could also prove to be our very best friend too offering a way to diagnose the disease without using invasive nasal swabs.

When COVID-19 testing began in earnest, the most common biosample used to test for the virus was the nasopharyngeal approach, which required a medical professional to conduct a (usually painful) nasal swab on a patient. This, coupled with risk to healthcare workers and a global shortage of swabs for sampling caused researchers around the world to seek viable alternatives.

Rutgers Study Proves Viability of Saliva Samples for COVID-19 Tests

Dr. Andrew Brooks, COO at RUCDR

[Dr. Andrew Brooks, COO at RUCDR]

A clinical study by Rutgers’ RUCDR Infinite Biologics evaluated the use of saliva as a specimen type for detection of SARS-CoV-2 in patients who are suspected of COVID-19. The study exclusively used the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. Results successfully validated saliva as being a viable biosample source for COVID-19 detection when compared to nasopharyngeal or oropharyngeal swabs. The resourceful discovery came just in time to deliver a better testing solution as traditional testing supplies became increasingly difficult to find including swabs and personal protective equipment. FDA issued EUA based on these findings.

  • Breakthrough Results: There was 100% positive and negative agreement between the results obtained from testing of saliva and those obtained from nasopharyngeal and oropharyngeal swabs. 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 inactivate the virus while protecting the COVID-19 transcripts for over 10 days in extreme climate conditions making sample collection and transport to CLIA testing labs more efficient and amenable to global at-home testing. Self-collection additionally uncovered and delivered the additional element of safety and extended protection to medical teams helping reduce the risk of further exposure and spread.
  • Researcher Quote: “The impact of this approval is significant,” said Andrew Brooks, chief operating officer and director of technology development at RUCDR, who also is a professor in the School of Arts and Sciences Department of Genetics at Rutgers University–New Brunswick. “It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections. We can preserve precious personal protective equipment for use in patient care instead of testing. We can significantly increase the number of people tested each and every day as self-collection of saliva is more quick and scalable than swab collections. All of this combined will have a tremendous impact on testing … across the United States.”
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University of Queensland:

Is Saliva Friend?Foe?

Diagnostics-saliva COVID-19The coronavirus disease 2019 (COVID-19) outbreak, caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) became a global ongoing pandemic. Timely, accurate, and non-invasive SARS-CoV-2 detection in both symptomatic and asymptomatic patients, as well as the determination of their immune status, will facilitate effective large-scale pandemic control measures to prevent the spread of COVID-19. This review focuses on the role of saliva as both a foe (a common mode of viral transmission via salivary droplets and potentially aerosols) and a friend (as a non-invasive diagnostic tool for viral detection and immune status surveillance) in combating COVID-19.

This review explores the potential role of saliva in the COVID-19 pandemic, as both a mechanism for the spread of the disease and a readily accessible diagnostic tool for detecting the presence of the virus, as well as an individual’s immune status.

  • Results: saliva can be used to diagnose the novel coronavirus infection, and even help monitor immunity to the virus.
  • Saliva is a “potent” biofluid source option for the detection of SARS-CoV-2 since it is non-invasive, easy-to-access, and low-cost.
  • Saliva can be stored at -80 °C for several years with little degradation.
  • Researcher Quote: “Ironically, saliva is a leading way that disease is transmitted, via droplets on surfaces and in the air, but it can also be incredibly useful to us for diagnosing the virus and monitoring a person’s health,” said Dr. Pingping Han, a postdoctoral research fellow in UQ’s School of Dentistry. “Indeed, saliva may be useful for both diagnosing the presence and sequelae of COVID-19 infection, as well as identifying and tracking the development of immunity to the virus.”

 

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Received: 21 April 2020 / Revised: 6 May 2020 / Accepted: 7 May 2020 / Published: 9 May 2020
Han, P.; Ivanovski, S. Saliva—Friend and Foe in the COVID-19 Outbreak. Diagnostics 2020, 10, 290.

Yale University:

Saliva offers GREATER detection sensitivity and consistency than nasal swabs.

Yale University Research Study Proof Point- Saliva More Sensitive for COVID-19 Detection Than Naso-Swabs50 researchers at Yale University sought to validate saliva as a new diagnostic approach over nasopharyngeal swabs because swabs offer low sensitivity, exposure risks to healthcare workers, and global shortages of swabs and personal protective equipment.

  • Results: Saliva samples taken from just inside the mouth provided greater detection sensitivity and consistency throughout the course of an infection than the broadly recommended nasopharyngeal (NP) approach.
  • The study also concluded: there was less variability in results with the self-sample collection of saliva.
  • Researcher Quote: “Taken together, our findings demonstrate that saliva is a viable and more sensitive alternative to nasopharyngeal swabs and could enable at-home self-administered sample collection for accurate large-scale SARS-CoV-2 testing,” said first author Anne Wyllie, an associate research scientist at the Yale School of Public Health and a member of its Public Health Modeling Unit.
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About the Product

Innovative Engineering
SDNA-1000

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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.

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