EUA200090 states, “Saliva specimens must be collected, transported and stored using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.”
Spectrum Solutions, LLC today announced the FDA Emergency Use Authorization (EUA) approval for the immediate use of saliva in COVID-19 testing exclusively using the Spectrum SDNA-1000 saliva collection device which has been proven to protect and preserve RNA used for the detection of infection.
The issued EUA for saliva as a viable biosample in COVID-19 testing came from the result of a detailed saliva vs. swab study strategically looking for an answer to the devastating swab and media supply shortages felt not only nationwide but globally. The study conclusion uncovered a novel, and technically robust testing alternative using saliva collected with Spectrum’s SDNA-1000 saliva collection device. These results fast-tracked EUA approval for RUCDR Infinite Biologics – Rutgers Clinical Genomics Laboratory and its Perkin Elmer nucleic acid extraction and ThermoFisher TaqPath SARS-CoV-2 automated processes using the Spectrum Solutions SDNA-1000 device.
“Using saliva to test for COVID-19 overcomes many of the challenges the nation faces that are inherent to current testing methods including supply shortages and risks to exposure for healthcare professionals,” said Stephen Fanning, CEO of Spectrum Solutions. “Now, under a medical professional’s direction, the saliva collection can be self-administered by individuals who may be in quarantine or self-isolation, removing the need to be in close contact with medical staff.”
“The Spectrum Solutions SDNA-1000 Saliva Collection Device was chosen to collect, transport and store saliva specimens for the TaqPath SARS-CoV-2 Assay proof-point study given RUCDR’s experience with Spectrum products across a wide range of applications currently employed,” said Dr. Andrew Brooks, Chief Operating Officer at RUCDR Infinite Biologics and Professor of Genetics at Rutgers University. “The preservation solution was a main focus of the study to ensure that the virus would be inactivated to the point that we would be able to maintain and stabilize the RNA transcripts for sensitive and specific QPCR analysis in order to determine whether a person has the virus. The device’s intuitive ease-of-use to facilitate minimally supervised or in most cases complete self-collection is a tremendous advance to current COVID-19 sample collection strategies. Together, these benefits will significantly add to expanding access to critical testing needs.”