The NT-proBNP-Access assay had very high diagnostic accuracy for acute heart failure (AUC 0.914), though slightly lower than the NT-proBNP-Elecsys assay (AUC 0.922, P=0.006).
Observational (n=1,400)
Blinded
Yes
Does the NT-proBNP-Access assay accurately diagnose acute heart failure in patients presenting with acute dyspnea to the emergency department compared to the NT-proBNP-Elecsys assay?
The NT-proBNP-Access assay provides high diagnostic accuracy for acute heart failure but yields values approximately 25% higher than the Elecsys assay, suggesting a need for assay-specific clinical decision cutoffs to avoid diagnostic discordance.
Absolute Event Rate: 0.914% vs 0.922%
p-value: p=0.006
Abstract Background The performance of the novel NT-pro-B-type natriuretic peptide (NT-proBNP)-Access assay in the early diagnosis of acute heart failure (AHF) is unknown. Methods In a prospective multicenter diagnostic study enrolling patients presenting with acute dyspnea to the emergency department (ED), NT-proBNP-Access was measured in a blinded fashion and directly compared to NT-proBNP-Elecsys concentrations. The primary endpoint was diagnostic accuracy quantified by Area-under-the-Receiver-Operating-Curve (AUC). Secondary endpoints were the performance of the guideline-recommended clinical decision values (rule-out: 300 pg/mL, rule-in: age-adjusted 450/900/1800 pg/mL) for AHF. Results Among 1400 patients (46 % women, median age 76 years), AHF was the adjudicated diagnosis in 744 patients (53%). Overall, the NT-proBNP-Access assay yielded significantly higher NT-proBNP concentrations versus the NT-proBNP-Elecsys assay (median 2087 (IQR 420-7150) pg/mL versus 1568 (IQR 271-5501) pg/mL, p0.001). The NT-proBNP-Access assay had very high diagnostic accuracy (AUC: 0.914, 95%CI 0.898-0.93), which was slightly lower versus the NT-proBNP-Elecsys assay (AUC 0.922 (95%CI 0.908-0.937, p=0.006). Using guideline-recommended clinical decision values fewer patients were ruled-out (18.7% vs. 26.3%) with similar sensitivity (98.9% vs. 98.5%), and more patients were ruled-in (58.1% vs 52.1%) with lower specificity (77.6% vs. 84.8%, p 0.001) with the NT-proBNP-Access assay versus NT-proBNP-Elecsys. Diagnostic concordance was high (85.3%), major mismatch (no AHF versus AHF) uncommon (0.6%), but minor mismatch common (14.1%, e.g., grey zone versus no AHF). Conclusions The NT-proBNP-Access assay had very high diagnostic accuracy for AHF. Levels were about 25% higher with NT-proBNP-Access versus NT-proBNP-Elecsys, resulting in diagnostic discordance in 1 out of 7 patients using guideline-recommended decision values.Comparison of NT-proBNP-Access & Elecsys Triage pathway to diagnose AHF
Belkin et al. (2025) conducted an observational in Acute heart failure (AHF) (n=1,400). NT-proBNP-Access assay vs. NT-proBNP-Elecsys assay was evaluated on Diagnostic accuracy quantified by Area-under-the-Receiver-Operating-Curve (AUC) (p=0.006). The NT-proBNP-Access assay had very high diagnostic accuracy for acute heart failure (AUC 0.914), though slightly lower than the NT-proBNP-Elecsys assay (AUC 0.922, P=0.006).