NEW YORK — Ortho Clinical Diagnostics said on Tuesday that it has received a CE mark for its total antibody SARS-CoV-2 test.
The test is designed to detect immunoglobulin A, immunoglobulin M, and immunoglobulin G antibodies against SARS-CoV-2 in blood and has demonstrated 100 percent specificity and sensitivity. It runs on the Raritan, New Jersey-based company's Vitros XT 7600 Integrated System, Vitros 3600 Immunodiagnostic System, and Vitros 5600 Integrated System, and it will soon be available for use with the Vitros ECi/ECiQ Immunodiagnostic Systems.
The test was granted Emergency Use Authorization by the US Food and Drug Administration last month.
Ortho Clinical said it intends to manufacture several million of the total antibody tests each month in its New York and Wales facilities.