Immunodiagnostics Systems' new Covid-19 test achieves CE marking

(Sharecast News) - Clinical laboratory diagnostics solutions provider Immunodiagnostic Systems' new automated Covid-19 gig assay has achieved CE marking and is now expected to be made available for sale by the end of June.
Immunodiagnostic said the test, a result of its partnership with IDS and Technogenetics, will be sold, marketed and supported by IDS on a global basis.

Unlike many Covid-19 serology assays currently available, the AIM-listed firm said its test was a quantitative assay, which 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, Immunodiagnostic believes quantitative tests may ultimately be valuable in determining immunity status based on levels of antibody in the blood.

Immunodiagnostic stated the test was "highly accurate" with a sensitivity of 100% and a specificity of 99.4%, meeting the performance criteria specified by the Medicines and Healthcare products Regulatory Agency and the Royal College of Pathology.

Chief executive Jaap Stuut said: "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.

"We anticipate launching this assay throughout Europe later this month."

As of 1050 BST, Immunodiagnostic shares had skyrocketed 80.48% to 379p.