12 Jun 2020 07:00
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.
IDS-iSYS analysers are already installed in over six hundred laboratories worldwide, including many NHS hospitals. The majority of these analysers are in territories which use the CE mark as the basis for regulatory approval. Each system is capable of running over 10,000 tests per month.
Jaap Stuut, CEO of IDS commented
"We are pleased that our collaboration with Technogenetics has achieved the important milestone of CE-marking a quantitative, fully automated SARS-CoV-2 antibody test running on the IDS-iSYS analyser. We anticipate launching this assay throughout Europe later this month. IDS has increased production levels of its analysers, and we have sufficient inventory levels to facilitate higher analyser placement levels driven by new customers wishing to run the Test."
About IDS
IDS is a specialist in-vitro diagnostic provider to the clinical laboratory market. IDS develops, manufactures and markets innovative immunoassays and automated immuno-analyser technologies to provide improved diagnostic outcomes for patients. IDS is headquartered in Boldon, UK, and listed on the Alternative Investment Market of the London Stock Exchange.
About Technogenetics
Technogenetics is an innovative company, based in Lodi, Italy, that has been active for over 30 years in the areas of diagnostic research and biotechnology. Since December 2015, Technogenetics is part of the KHB Group, headquartered in Shanghai, and is engaged in complex and ambitious challenges with the aim of offering the market increasingly efficient and advanced diagnostic solutions. KHB is listed on the Shenzhen Stock Exchange.
1 Diagnostic sensitivity of the Test was calculated across 110 samples drawn from symptomatic Italian patients in March and April 2020. For blood samples taken 21 days or more after onset of symptoms, diagnostic sensitivity was 100% (all samples positive). The diagnosis of Sars-CoV-2 infection of those patients was confirmed in nasopharyngeal swab samples by RT-PCR, specific for the SARS-CoV-19 virus
2 Initial data demonstrated an overall diagnostic specificity of 99.4%, with 331 of 333 presumptive negative samples testing negative with the Test. These negative samples came from both pre-epidemic blood donors, as well as routine laboratory samples taken during the epidemic, some with influenza or other potentially interfering pathologies.
For further information:
Immunodiagnostic Systems Holdings plc Tel: +44 (0) 191 519 6111
Jaap Stuut, Chief Executive Officer
Paul Martin, Group Finance Director
Peel Hunt LLP Tel: +44 (0) 20 7418 8900
James Steel
Oliver Jackson