Ortho Clinical Diagnostics (NSDQ:OCDX) announced today that its new Vitros SARS-CoV-2 antibody assays received CE Mark approval.
Raritan, N.J.-based Ortho Clinical Diagnostics’ Vitros anti-SARS-CoV-2 total 2 antibody assay and the Vitros anti-SARS-CoV-2 IgG 2 antibody assay both received European approval for the qualitative and semi-quantitative detection of COVID-19 antibodies, according to a news release.
Both antibody assays generate a positive or negative result while also offering a measurement value for SARS-CoV-2 antibodies with easy-to-read results that are designed to eliminate the need for repeat testing and improve lab workflow. They can also be used to assess titers of neutralizing antibodies that generate the protective immune response and they can identify plasma suitable for convalescent plasma therapy.
The assays run on Ortho’s high-throughput, fully-automated analyzers, including the Vitros XT 7600 integrated system, the Vitros 3600 immunodiagnostic system, the Vitros 5600 integrated system and the Vitros ECi/ECiQ immunodiagnostic systems.
Ortho intends to manufacture millions of COVID-19 antibody tests per month at a Pencoed, Wales facility.
“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,” Ortho chief innovation officer Chockalingam Palaniappan said in the news release. “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.”