ELITechGroup Submits SARS-CoV-2 Plus ELITe MGB Assay for FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 18 Nov 2020

ELITech Group has submitted its new SARS-CoV-2 Plus ELITe MGB Assay to the US Food & Drug Association (FDA) for Emergency Use Authorization (EUA). The 4 in 1 test will help fight against the novel coronavirus amidst its growing spread and the flu season.

The 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 assay uses RNase P as an endogenous control for increased test reliability and is designed for use on a variety of existing lab instruments, including the ELITe InGenius.

Image: SARS-CoV-2 Plus ELITe MGB Assay (Photo courtesy of ELITechGroup)

"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."