ELITechGroup Submits SARS-CoV-2 Plus ELITe MGB Assay for FDA Emergency Use Authorization
By LabMedica International staff writers Posted on 18 Nov 2020 |
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."
Latest COVID-19 News
- New Immunosensor Paves Way to Rapid POC Testing for COVID-19 and Emerging Infectious Diseases
- Long COVID Etiologies Found in Acute Infection Blood Samples
- Novel Device Detects COVID-19 Antibodies in Five Minutes
- CRISPR-Powered COVID-19 Test Detects SARS-CoV-2 in 30 Minutes Using Gene Scissors
- Gut Microbiome Dysbiosis Linked to COVID-19
- Novel SARS CoV-2 Rapid Antigen Test Validated for Diagnostic Accuracy
- New COVID + Flu + R.S.V. Test to Help Prepare for `Tripledemic`
- AI Takes Guesswork Out Of Lateral Flow Testing
- Fastest Ever SARS-CoV-2 Antigen Test Designed for Non-Invasive COVID-19 Testing in Any Setting
- Rapid Antigen Tests Detect Omicron, Delta SARS-CoV-2 Variants
- Health Care Professionals Showed Increased Interest in POC Technologies During Pandemic, Finds Study
- Set Up Reserve Lab Capacity Now for Faster Response to Next Pandemic, Say Researchers
- Blood Test Performed During Initial Infection Predicts Long COVID Risk
- Low-Cost COVID-19 Testing Platform Combines Sensitivity of PCR and Speed of Antigen Tests
- Finger-Prick Blood Test Identifies Immunity to COVID-19
- Quick Test Kit Determines Immunity Against COVID-19 and Its Variants