The Covid-19 IgG Antibody Test by Ortho Clinical Diagnostics gets CE Mark

The WHO standardisation helps in the regulation of Covid-19 virus serological methods and allows for cross-lab data comparison. The new assay is designed to detect IgG antibodies to SARS-CoV-2 in human serum and plasma in a qualitative and quantitative manner. The test would make it easier to determine a person’s immune response after being infected with the SARS-CoV-2 virus or having a vaccine.

It will be used as a standardised method for public health staff to measure improvements in Covid-19 patients’ antibody levels and monitor the disease’s spread. Chockalingam Palaniappan, the Ortho Clinical Diagnostics chief innovation officer, said, “Ortho’s new quantitative IgG antibody test provides healthcare teams and researchers with a standardised 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.”

The test, which has a 100% accuracy and a high sensitivity, is run on the company’s VITROS device. On the more than 5,600 analysers that Ortho Clinical Diagnostics has built around the world, up to 6.8 million of its Covid-19 samples can be processed in a day. Each month, the company plans to manufacture up to eight million quantitative IgG antibody tests.

The VITROS Anti-SARS-CoV-2 IgG Quantitative test is a recent addition to Ortho’s Coronovirus portfolio, and it can be used to diagnose and treat coronavirus infections as well as monitor people’s immune responses. The new VITROS Anti-SARS-CoV-2 IgG Quantitative (QN) Antibody assay from Ortho Clinical Diagnostics has gained CE certification, indicating that it meets the World Health Organization (WHO) International Standard.