New Jersey-based Rutgers University’s RUCDR Infinite Biologics and its collaborators have been granted emergency use authorization (EUA status) for their saliva-based COVID-19 test by the US Food and Drug Administration (FDA).
The new COVID-19 test uses saliva as the main test biomaterial for the SARS-CoV-2 coronavirus.
The EUA status permits the immediate use of saliva in COVID-19 testing by using the Spectrum SDNA-1000 saliva collection device. Developed by Spectrum Solutions, the SDNA-1000 saliva collection device is said to have been proven to protect and preserve RNA used for detecting an infection.
Stephen Fanning – Spectrum Solutions CEO said: “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.
“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.”
RUCDR Infinite Biologics along with Spectrum Solutions and Accurate Diagnostic Labs (ADL) worked together to develop the new saliva collection method, which is expected to enable screening of a broader population compared to the present method of nose and throat swabs.
The EUA status from the FDA was granted to the saliva-based COVID-19 test based on the findings of a saliva vs swab study that proved saliva collected with Spectrum’s SDNA-1000 saliva collection device to be a technically robust testing alternative.
The results led to an accelerated EUA status 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 SDNA-1000 device.
Dr Andrew Brooks – Chief Operating Officer at RUCDR Infinite Biologics and Professor of Genetics at Rutgers University, said: “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.
“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.”