ELITechGroup Submits SARS-CoV-2 Plus ELITe MGB Assay for FDA Emergency Use Authorization
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By HospiMedica International staff writers Posted on 18 Nov 2020 |
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Image: SARS-CoV-2 Plus ELITe MGB Assay (Photo courtesy of ELITechGroup)
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.
"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."
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.
"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."
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