Beaton to it12 Jun 2020 11:18
Immunodiagnostic Systems Holdings plc.
12 June 2020
Automated assay to detect SARS-CoV-2 antibodies
Immunodiagnostic Systems Holdings plc (IDS), a specialty solution provider to the clinical laboratory diagnostic market, announces a new automated COVID-19 IgG assay (The Test) has achieved CE marking and is expected to be available for sale by the end of this month.
The Test, which arises from the partnership between IDS and Technogenetics, is designed to run on the automated IDS-iSYS analyser. Today IDS and Technogenetics reached a commercial agreement under which IDS shall sell, market and support this Test on a global basis. For territories which do not accept CE marked products, the requisite regulatory approvals will be required.
Test Overview
· Detects specific IgG antibodies indicating past exposure to the COVID-19 virus and immune response;
· Quantitative test determines antibody concentration (titer), not just a 'yes/no' result;
· Highly accurate with a sensitivity of 100%1 and a specificity of 99.4%2, thus meeting the performance criteria specified by MHRA and the Royal College of Pathology, as well as the most common international performance requirements;
· Test results available within 25 minutes.
Unlike many COVID-19 serology assays currently available, this Test is a quantitative assay. It can determine the antibody concentration in patient serum, rather than giving a 'yes/no' result for prior exposure to the virus. Although the clinical level of functional immunity conferred by SARS-CoV-2 IgG antibodies has not yet been determined, we believe quantitative tests may ultimately be valuable in determining immunity status based on the levels of antibody in the blood.
All steps of the Test are automated with no manual reagent preparation required, ensuring minimal hands-on time for lab staff and a high daily throughput.