November 17, 2020
SARS-CoV-2 Plus ELITe MGB® Assay has been submitted to the U.S. Food & Drug Association’s for Emergency Use Authorization , following the Molecular Diagnostic Template for Commercial Manufacturers.
SARS-CoV-2 Plus ELITe MGB Assay is for the in vitro qualitative detection and differentiation of RNA from the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (Flu A), Influenza B (Flu B) and Respiratory Syncytial Virus (RSV) in nasopharyngeal/ oropharyngeal swabs and nasal specimens from patients suspected of COVID-19 by a healthcare provider.
The SARS-CoV-2 Plus ELITe MGB Assay is developed and manufactured in Bothell, Wash., and it uses RNase P as an endogenous control for increased test reliability. It is designed for use on a variety of existing lab instruments, including the ELITe InGenius®.
“This fall, the United States has seen an alarming surge of COVID-19 cases, and now more than ever, it’s critical we focus on making reliable testing accessible for all health systems,” said Christoph Gauer, ELITechGroup CEO. “By submitting our SARS-CoV-2 Plus ELITe MGB® Assay to the FDA for EUA approval, we will provide critical tests that can accurately differentiate from the novel coronavirus and anticipated flus for adults and children.”
Additional information can be found here.