6 April 2020 - - Researchers from RUCDR Infinite Biologics at Rutgers University, using the Spectrum DNA SDNA-1000 Whole Saliva Collection Device, have successfully validated saliva as being a viable biosample source for COVID-19 detection when compared to nasopharyngeal or oropharyngeal swabs, US-based Spectrum Solutions, LLC's Spectrum DNA division said.

The resourceful discovery has come just in time to answer the consistent exponential increase in test demand.

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' 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, opposed to nasal swab biosample collection requiring up-close medical assistance.

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 an EUA.

Spectrum Solutions has manufactured over 10 m 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.

Ensuring sample stability at a variety of temperatures enables the primary sample to be shipped as well as easily stored in case repeat testing is required.

The product is available now and currently being used as a biosample collection option for viral DNA/RNA COVID-19 testing--allowing hospital networks, health departments, and clinical research organisations 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.

Headquartered in Salt Lake City, Utah, Spectrum Solutions and its medical device and services division, Spectrum DNA, focus on innovative, end-to-end product development, manufacturing, and global fulfillment solutions.

With concentrated industry expertise, Spectrum DNA specializes in engineering innovative molecular diagnostic solutions that simplify the biosample collection process while offering donors complete physical and digital chain-of-custody.

With on-site production facilities, we are a single-source provider of full-service medical device manufacturing, custom and private label packaging, kitting, and direct-to-donor global fulfillment.

Its new biosample collection devices, patented technology, and services provide measurable process optimization, unprecedented efficiency, and unmatched global scalability.