NEW YORK ─ Ortho Clinical Diagnostics said Monday it had received a CE mark for its Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test, also called the COVID-19 IgG antibody test, which detects IgG antibodies against SARS-CoV-2.
According to Ortho, the test has 100 percent specificity.
CE marking for the IgG antibody test closely follows the receipt of a previous CE mark and subsequent introduction of the company's Ortho’s COVID-19 Total test, which detects immunoglobulin A, immunoglobulin M, and immunoglobulin G antibodies against SARS-CoV-2 in blood.
"The observed 100 percent 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,” Christopher Hillyer, president and CEO of the New York Blood Center, said in a statement. "Statistically, the chance of error rises dramatically even with a very small decline from 100 percent in specificity, given our understanding of the prevalence of the COVID-19 virus today."
Ortho said both tests help healthcare professionals understand whether a patient has been exposed to and developed antibodies to the SARS-CoV-2 coronavirus. Together the antibody tests provide a greater choice of testing options in tracking and surveillance, patient management, and screening convalescent plasma, the firm said.
Ortho said it has a global installed base of more than 5,600 immunodiagnostic systems. Both antibody tests run on the firm's high-throughput, fully automated analyzers, including the Vitros XT 7600 Integrated System, Vitros 3600 Immunodiagnostic System, and Vitros 5600 Integrated System, and the tests will soon be available on its Vitros ECi/ECiQ Immunodiagnostic Systems.
The Raritan, New Jersey-based in vitro diagnostic company is manufacturing the COVID-19 IgG antibody tests at its facility in Pencoed, UK. It has begun shipping its antibody test to customers in highly impacted geographies and plans to manufacture several million coronavirus antibody tests in the coming weeks and each month.