Coronavirus company news summary - FDA to authorise Ortho Clinical Diagnostics’ Covid-19 IgG antibody test - QuantuMDx launches Q-POC rapid point of care diagnostic system - Verdict Medical Devices
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Coronavirus company news summary – FDA to authorise Ortho Clinical Diagnostics’ Covid-19 IgG antibody test – QuantuMDx launches Q-POC rapid point of care diagnostic system

12 Jul 2021

Ortho Clinical Diagnostics has announced that its VITROS anti-SARS-CoV-2 IgG quantitative test is the first quantitative Covid-19 IgG antibody test to receive Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Ortho’s new quantitative test targets the S1 spike protein to identify individuals with an adaptive immune response to the SARS-CoV-2 virus. It provides 100% specificity and sensitivity.

QuantuMDx Group, a UK-based point-of-care diagnostics developer, has announced the launch of Q-POC, a rapid, PCR point-of-care diagnostic system. QuantuMDx’s Q-POC system and its SARS-CoV-2 detection assay are now CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC). The Q-POC SARS-CoV-2 assay has been examined at St George’s, University of London, to measure clinical performance against tests in current use. The Development and Assessment of Rapid Technology (DART) study has found 96.9% sensitivity, 98.3% specificity, and 0% cross-reactivity with common commensal or potentially interfering organisms.

Researchers at RMIT University have collaborated with partners, including the Australian biomedical start-up Soterius, to develop an instant biosensor that can detect the SARS-CoV-2 virus and its variants. The non-invasive Soterius Scout sensor delivers results in just a minute, thereby helping frontline workers and the wider community by alerting them to undertake a Covid-19 test and self-isolate if required. A prototype is being developed further by Soterius in partnership with RMIT, the Burnet Institute, MIP Diagnostics and D+I and Vestech, and is expected to be released in early 2022. The technology will be manufactured in Australia and will be delivered to hospitals first, with future applications in other settings including aged care, airports, quarantine hotels and schools.