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Ortho Clinical Diagnostics Obtains CE Mark for Quantitative SARS-CoV-2 Antibody Test

NEW YORK ─ Ortho Clinical Diagnostics on Wednesday announced that it has obtained the CE mark for its Vitros Anti-SARS-CoV-2 IgG Quantitative Antibody test and has launched it for use in the European Union and other regions that accept the designation.

The assay provides qualitative and quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma and is processed on Ortho's Vitros system, the firm said.

The test has 100 percent specificity and 94 percent sensitivity greater than 15 days after symptom onset, Ortho said.

"Ortho's new quantitative IgG antibody test provides healthcare teams and researchers with a standardized data ruler to assess immune response acquired through infection or from vaccines over time, offering additional data to help manage and understand this devastating virus," Chockalingam Palaniappan, Ortho Clinical's chief innovation officer, said in a statement.

Raritan, New Jersey-based Ortho said that its assay provides numerical values traceable to a World Health Organization international standard that helps standardize SARS-CoV-2 serological methods and allows for unified data comparison across laboratories.

Up to 6.8 million Ortho COVID-19 tests can be processed daily on its installed base of more than 5,600 analyzers, the firm said.

The company said it is planning to manufacture up to 8 million quantitative IgG antibody tests per month. In April, it announced a $53.7 million US government agency contract to support a more than threefold increase in US production of its COVID-19 antibody and antigen diagnostic tests.

The company obtained the CE mark in November and US Food and Drug Administration Emergency Use Authorization in January for its Vitros SARS-CoV-2 Antigen Test for active infection.