LONDON: Immunodiagnostic Systems Holdings plc (IDS), a specialty solution provider to the clinical laboratory diagnostic market, announced fully automated SARS-CoV-2 IgG antibody test will be available for sale.
The test can now be purchased by customers in the UK, the EU, and a number of other countries which accept the CE mark as the basis of regulatory approval. “We have commenced the process of working with various national reference centers and governmental bodies to ensure a roll-out according to national guidelines,” a statement said.
Jaap Stuut, CEO of IDS commented: “We are pleased to announce the release to the market of our automated SARS-CoV-2 antibody test, running on the IDS-iSYS analyser. IDS will now seek to commercialise this test via our direct sales force in Europe, and through our extensive distribution network elsewhere, and we look forward to joining the efforts to minimise the impact of the COVID-19 virus.”
The Test, which arises from the partnership between IDS and Technogenetics, is designed to run on the installed base of over 600 automated IDS-iSYS analysers. The Test:
- Detects specific IgG antibodies indicating past exposure to the COVID-19 virus and immune response;
- Is a quantitative test which determines antibody concentration (titer);
- Is highly accurate with a sensitivity of 100% and a specificity of 99.4%;
- Provides Test results available within 25 minutes.
Unlike many COVID-19 serology assays currently available, this Test is a quantitative assay, thus it can determine the antibody concentration in patient serum. 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.