Ortho receives CE Mark for enhanced Vitros immunodiagnostic products NT-proBNP II Assay, an aid in diagnosing and assessing heart failure

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, announced the CE Mark of an enhanced version of its Vitros NT-proBNP II assay, part of Ortho’s expansive cardiac menu. The analytical characteristics and clinical performance of the Vitros NT-proBNP II assay allow clinicians to efficiently assess heart failure patients. The assay is designed for the aid in diagnosis of heart failure and for the risk stratification of acute coronary syndrome and heart failure.

It is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients who have stable coronary artery disease and in the assessment of heart failure severity in patients diagnosed with heart failure.

The CE Mark of the Vitros NT-proBNP II assay comes following Ortho’s recent launch of its High Sensitivity Troponin I assay, also CE Marked and a critical tool for clinicians who are seeking improved strategies to more rapidly and accurately identify patients suffering from a heart attack. Both the Vitros NT-proBNP II and Troponin I assays can run on Ortho’s Vitros XT 7600 Integrated System, the Vitros 5600 Integrated System, Vitros 3600 Immunodiagnostic System and the Vitros ECi/ECiQ Immunodiagnostic Systems.

Comment: The assay is also designed for risk stratification — grouping patients based on their risk and rising risk — of acute coronary syndrome and heart failure. The enhanced version of the assay has improved assay quality through the use of monoclonal antibodies and an enhanced resistance to potential interferences..