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March 9, 2021

Ortho’s two Covid-19 antibody assays receive CE Mark

Ortho Clinical Diagnostics has received CE Mark for two of its assays for qualitative and semi-quantitative detection of Covid-19 antibodies.

Ortho Clinical Diagnostics has received CE Mark for two of its assays for qualitative and semi-quantitative detection of Covid-19 antibodies.

The new VITROS Anti-SARS-CoV-2 Total 2 Antibody assay and VITROS Anti-SARS-CoV-2 IgG 2 Antibody assay offer a measurement value of SARS-CoV-2 antibodies with easily readable results that eradicate the requirement for repeated testing and enhance lab workflow.

Ortho’s Total 2 and IgG 2 antibody assays generate a positive (reactive) or negative (non-reactive) result with 100% specificity and exceptional sensitivity.

The assays could help clinicians to understand each patient’s adaptive immune response (developed naturally after infection or via vaccination) to SARS-CoV-2.

They can also be used for evaluating titers of neutralising antibodies responsible for protective immune response and to detect plasma suitable for convalescent plasma therapy.

Ortho Clinical Diagnostics chief innovation officer Chockalingam Palaniappan said: “Across the world, there continues to be a great need for Covid-19 testing to understand if a person is infected, how they are responding to treatment or a vaccine, or to help assess the spread of the disease.

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“As a trusted partner to our customers from the beginning of this pandemic, Ortho will continue to bring to market solutions that help them quickly provide critical results to clinicians while keeping their lab running as efficiently as possible.”

The assays run on the company’s high-throughput, fully-automated analysers, including its VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System, and VITROS ECi/ECiQ Immunodiagnostic Systems.

The VITROS Systems are installed in more than 5,600 laboratories across the world. They can run more than 150 different blood and body fluid sample tests.

As they are installed globally, reporting times could be enhanced as lab staff need no additional training and the instruments are already linked to present laboratory information systems and software.

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