Ortho Launches Quantitative COVID-19 IgG Antibody Test with CE Mark

Ortho Clinical Diagnostics (Raritan, NJ, USA) has 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 key advantage 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 trusted 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 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," said Chockalingam Palaniappan, PhD, chief innovation officer, Ortho Clinical Diagnostics.