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Ortho Clinical Diagnostics Nabs CE Mark for Semi-Quantitative SARS-CoV-2 Antibody Tests

NEW YORK ─ Ortho Clinical Diagnostics said on Monday that it has obtained CE marking for its Vitros Anti-SARS-CoV-2 Total 2 Antibody assay and Vitros Anti-SARS-CoV-2 IgG 2 Antibody assay for the qualitative and semi-quantitative detection of COVID-19 antibodies, enabling use of the tests in the European Union and other regions that accept the designation. 

The assays help clinicians understand each patient's adaptive immune response to SARS-CoV-2, acquired through infection or vaccination, Ortho said. The tests can be used to assess titers of neutralizing antibodies that are responsible for a protective immune response and to identify plasma suitable for convalescent plasma therapy, the company added.

Ortho's Total 2 and IgG 2 antibody assays provide easy-to-read results that eliminate the need for repeat testing and improve lab workflow, the firm said. The assays run on Ortho's high-throughput, fully automated analyzers including its flagship Vitros XT 7600 Integrated System, Vitros 3600 Immunodiagnostic System, Vitros 5600 Integrated System, and Vitros ECi and ECiQ Immunodiagnostic Systems.

Raritan, New Jersey-based Ortho noted that its high-volume Vitros systems are installed in more than 5,600 laboratories around the world and run a broad menu of more than 150 different tests from blood and body fluid samples. Additional analyzers can be quickly installed to increase capacity because they do not require an external water source to operate, Ortho noted.

The company said it plans to manufacture several million COVID-19 antibody tests each month in Pencoed, Wales.

Last April, the US Food and Drug Administration granted Emergency Use Authorizations for Ortho's total COVID-19 antibody test and SARS-CoV-2 IgG antibody tests. In January, the firm announced it had received FDA EUA for its Vitros SARS-CoV-2 Antigen test.