A-016 Clinical Performance Comparison Between the Vitros Immunodiagnostic Products NT-proBNP II and Roche Elecsys proBNP II Assays to Aid in the Diagnosis of Heart Failure

Abstract

Abstract Background The International Collaborative of NT-proBNP (ICON) study established NT-proBNP levels for the diagnosis and exclusion of acute heart failure for patients presenting to the emergency department (ED). Following the development of the Vitros Immunodiagnostic Products NT-proBNP II assay, a multi-center prospective study was conducted at 20 EDs across the United States. The study enrolled subjects presenting with dyspnea and clinical suspicion of heart failure (HF). Clinical performance of the Vitros Immunodiagnostic Products NT-proBNP II assay using the cutoffs established in the ICON study was compared to that of the Roche Elecsys proBNP II assay using samples from the multi-center study. Methods Clinical sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) were determined by comparing the assay result interpretation using the corresponding cutoffs against the adjudicated diagnosis of HF/non-HF. Clinical performances were then compared between the VITROS NT-proBNP II and the Roche Elecsys proBNP II assays. Analyses were performed using both the age-independent and age-dependent cutoffs within and across age groups. Results After applying the rule-in cutoffs from the ICON study to the Vitros NTproBNP II and the Roche Elecsys proBNP II assay results, the clinical performance of the Vitros NT-proBNP II assay was comparable to that of the Roche Elecsys proBNP II assay (see Table 1). Conclusion The use of the ICON cutoffs resulted in high assay specificity to rulein HF and excellent sensitivity to ruleout HF. The Vitros NT-proBNP II assay demonstrated comparable clinical performance to the Roche Elecsys proBNP II assay.