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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.

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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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