Ortho Clinical Diagnostics launches quantitative COVID-19 IgG Antibody Test with CE Mark

May 6, 2021  –  Ortho Clinical Diagnostics (Raritan, NJ) announced that its quantitative COVID-19 IgG antibody test has achieved CE Mark.

Ortho’s new VITROS Anti-SARS-CoV-2 IgG Quantitative (QN) Antibody assay provides numerical values traceable to the World Health Organization (WHO) International Standard, which helps standardize SARS-CoV-2 serological methods and allows for unified data comparison across laboratories. This will help clinicians determine the level of an individual’s immune response to SARS-CoV-2 after infection or vaccination and provide public health leaders with a standardized tool to measure changes in patients’ antibody levels to better track the spread of the virus.

With 100% specificity and excellent sensitivity, the VITROS Anti-SARS-CoV-2 IgG QN Antibody assay is intended for the qualitative detection and quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma and is processed on Ortho’s VITROS system. Up to 6.8 million of Ortho’s COVID-19 tests can be processed daily on Ortho’s globally installed base of over 5,600 analyzers.

Ortho plans to manufacture up to eight million quantitative IgG antibody tests each month.

Ortho’s VITROS SARS-CoV-2 Antigen Test, which achieved CE Mark in November 2020 and was authorized for use in the U.S. in January 2021, offers reliable detection of acute COVID-19 infection with high sensitivity and specificity.

Ortho’s antigen test can be processed at a rate of up to 130 tests per hour on a single analyzer, bolstering the ability of hospitals and reference labs to address testing backlogs, supply shortages, and delayed results that have undermined previous testing efforts.

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