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May 6, 2021

Ortho Clinical Diagnostics gets CE mark for Covid-19 IgG antibody test

Ortho Clinical Diagnostics has received CE mark for the new VITROS Anti-SARS-CoV-2 IgG Quantitative (QN) Antibody assay designed to offer values in line with the World Health Organisation (WHO) International Standard.

The WHO standardisation aids in regulating Covid-19 virus serological methods and permits unified data comparison across labs.

The new assay is indicated for the qualitative and quantitative identification of IgG antibodies to SARS-CoV-2 in human serum and plasma.

The test will facilitate analysis of a person’s immune response level on being infected with the SARS-CoV-2 virus or on receiving a vaccination. It will serve as a standardised tool for public health workers to assess changes in the antibody levels of Covid-19 patients and track the disease spread.

Ortho Clinical Diagnostics chief innovation officer Chockalingam Palaniappan 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, with a specificity of 100% and substantial sensitivity, is processed on the company’s VITROS system.

Ortho Clinical Diagnostics noted that as many as 6.8 million of its Covid-19 tests can be processed in a day on the more than 5,600 analysers that the company has installed acround the world.

The company intends to produce up to eight million quantitative IgG antibody tests monthly.

The VITROS Anti-SARS-CoV-2 IgG Quantitative test is the new addition to Ortho’s Covid-19 portfolio for detecting and treating Covid-19 infections as well as monitoring people’s immune response.

In March, Ortho Clinical Diagnostics received CE mark for two of its assays for qualitative and semi-quantitative detection of Covid-19 antibodies.

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