Ortho-Clinical Diagnostics has announced the FDA clearance and availability in the United States, Europe, and other international markets of an immunoassay that detects a key cardiac biomarker. The VITROS NT-proBNP assay, for use on the VITROS ECi/ECiQ immunodiagnostic system, quantitatively measures NT-proBNP (N-terminal pro Brain Natriuretic Peptide).
The VITROS NT-proBNP assay provides advanced testing capabilities to aid in the diagnosis of congestive heart failure (CHF) and risk stratification of acute coronary syndrome and congestive heart failure, and as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.
The VITROS NT-proBNP assay represents a further expansion of the Ortho-Clinical Diagnostics immunoassay cardiology menu. The assay is performed using the VITROS Immunodiagnostic Products NT-proBNP Reagent Pack and VITROS Immunodiagnostic Products NT-proBNP Calibrators. The VITROS NT-proBNP assay further enhances the VITROS ECi /ECiQ Immunodiagnostic Systems’ existing cardiology offering of Troponin-I, CK-MB, and Myoglobin.
“The diagnosis of congestive heart failure is often difficult because of non-specific indicators and similarity to other disease states,” says Mark Straley, vice president, worldwide marketing, Ortho-Clinical Diagnostics. “Procedures for diagnosis are often expensive and invasive for the patient. The VITROS NT-proBNP assay will provide physicians with a means to aid in the differential diagnosis of congestive heart failure. Ortho-Clinical Diagnostics is proud to be a leader in the cardiac marker market with this and other important assays.”
NT-proBNP is included in the practice guidelines of the European Society of Cardiology Task Force and the American College of Cardiology/American Heart Association. The VITROS NT-proBNP assay improves laboratory operations and confidence in results with rapid time to first result of 16 minutes and sample stability up to 3 days at room temperature. It shows clinical agreement to the Roche Elecsys® proBNP immunoassay.
According to Ortho-Clinical Diagnostics, the VITROS NT-proBNP assay is designed and integrated with the VITROS ECi /ECiQ System to help ensure quality results using Intellicheck® Technology and excellent assay performance with MicroWell™ and proprietary Enhanced Chemiluminescence detection technology. The reagent pack is stable on board for up to 12 weeks with calibration stability of up to 28 days. The reportable range is 5 – 35,000 pg/mL (0.590 – 4130 pmol/L) which helps minimize unnecessary dilutions and repeats. Excellent precision is demonstrated across the NT-proBNP reportable range. The assay performance and integration with the VITROS ECi /ECiQ Immunodiagnostic System provides security in results, and improvements in workflow, turnaround times, and labor efficiency and effectiveness.