In-vitro diagnostics developer Ortho Clinical Diagnostics has received the CE mark for its Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test, also called the Covid-19 IgG antibody test.
According to Ortho, the test detects IgG antibodies against SARS-CoV-2 and has 100% specificity.
Ortho Clinical Diagnostics CEO Chris Smith said: “Ortho is proud that both of our Covid-19 Total and IgG tests are achieving 100% specificity.
“During this health crisis, good is simply not good enough. This high level of specificity is a testament to Ortho’s strong belief that every test is a life.”
CE marking for the IgG antibody test closely follows the receipt of an earlier CE mark and subsequent introduction of the company’s Ortho’s Covid-19 Total test that detects immunoglobulin A, immunoglobulin M and immunoglobulin G antibodies against SARS-CoV-2 in blood.
Last month, the Covid-19 IgG antibody test received emergency use authorisation (EUA) from the US Food and Drug administration (FDA).
New York Blood Center president and CEO D Hillyer said: “The observed 100% specificity with Ortho’s VITROS SARS-CoV-2 tests allows an extremely high level of confidence so that people will not be identified as having an immune response to the virus when, in fact, they do not.
“Statistically, the chance of error rises dramatically even with a very small decline from 100% in specificity, given our understanding of the prevalence of the Covid-19 virus today.”
In July last year, Ortho Clinical Diagnostics received the European CE Mark for its VITROS NT-proBNP II assay designed to help diagnose heart failure.
In December 2017, the company received FDA approval for its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (Vitros HIV Combo test).