Pure-play in vitro diagnostics (IVD) company Ortho Clinical Diagnostics has secured CE mark approval for its VITROS Anti-SARS-CoV-2 Total 2 Antibody assay.

The company has also secured CE mark approval for the VITROS Anti-SARS-CoV-2 IgG 2 Antibody assay for the qualitative and semi-quantitative identification of Covid-19 antibodies.

Ortho’s Total 2 and IgG 2 antibody assays provide a measurement value of SARS-CoV-2 antibodies with easy-to-read results, in addition to generating a positive (reactive) or negative (non-reactive) results.

According to the company, the assays help in eliminating the need for repeat testing and improve lab workflow.

Both antibody assays, which demonstrated 100% specificity and better sensitivity, will allow clinicians to better understand each patient’s adaptive immune response to SARS-CoV-2.

The tests will also help evaluate titers of neutralising antibodies, which are used for the detection of plasma suitable for convalescent plasma therapy.

Ortho Clinical Diagnostics chief innovation officer Dr 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.

“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 fully automated analysers such as VITROS XT 7600 integrated system, VITROS 3600 immunodiagnostic system, VITROS 5600 integrated system and VITROS ECi/ECiQ Immunodiagnostic systems are suitable to run both the antibody assays.

Ortho stated that its analysers generally run a menu of more than 150 different tests from blood and body fluid samples.

In October last year, the company secured CE mark approval for its VITROS SARS-CoV-2 antigen test for the identification of SARS-CoV-2 infection.