The NT-proBNP-Access assay demonstrated very high diagnostic accuracy for acute heart failure (AUC 0.914), which was 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 improve diagnostic accuracy for acute heart failure in patients presenting with acute dyspnea?
The NT-proBNP-Access assay provides high diagnostic accuracy for acute heart failure but yields values approximately 25% higher than the Elecsys assay, requiring awareness of potential minor diagnostic discordance when using standard cutoffs.
Absolute Event Rate: 0.914% vs 0.922%
p-value: p=0.006
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. OBJECTIVES: The objective of the study was to assess the diagnostic accuracy of NT-proBNP-Access in patients presenting with acute dyspnea and compare it to the established NT-proBNP-Elecsys assay. METHODS: In a prospective multicenter diagnostic study enrolling patients presenting with acute dyspnea to the emergency department, NT-proBNP-Access was measured in a blinded fashion and compared to NT-proBNP-Elecsys concentrations. The primary endpoint was diagnostic accuracy quantified by area under the receiver operating characteristics curve (AUC). Secondary endpoints were the performance of the guideline-recommended clinical decision values (rule-out: 450/900/1,800 pg/mL) for AHF. RESULTS: Among 1,400 patients (53% AHF), the NT-proBNP-Access assay yielded significantly higher NT-proBNP concentrations vs the NT-proBNP-Elecsys assay (median 2,087 pg/mL vs 1,568 pg/mL P < 0.001). The NT-proBNP-Access assay had very high diagnostic accuracy (AUC: 0.914; 95% CI: 0.898-0.93), which was slightly lower than the NT-proBNP-Elecsys assay (AUC: 0.922; 95% CI: 0.908-0.937; P = 0.006). Using guideline-recommended clinical decision values, the NT-proBNP-Access assay ruled out fewer patients compared to NT-proBNP-Elecsys (18.7% vs 26.3%) with similar sensitivity (98.9% vs 98.5%). Conversely, more patients were ruled in (58.1% vs 52.1%), with lower specificity (77.6% vs 84.8%; P < 0.001). Diagnostic concordance was high (85.3%), with major mismatch (no AHF vs AHF) uncommon (0.6%), but minor mismatch (gray zone vs rule in/rule out and vice versa) common (14.1%). CONCLUSIONS: The NT-proBNP-Access assay had a very high diagnostic accuracy for AHF. Levels were approximately 25% higher with NT-proBNP-Access vs NT-proBNP-Elecsys, resulting in minor diagnostic discordance in 1 of 7 patients using guideline-recommended decision values.
Belkin et al. (Wed,) conducted a observational in Acute heart failure (n=1,400). NT-proBNP-Access assay vs. NT-proBNP-Elecsys assay was evaluated on Diagnostic accuracy for acute heart failure (AUC) (95% CI 0.898-0.93, p=0.006). The NT-proBNP-Access assay demonstrated very high diagnostic accuracy for acute heart failure (AUC 0.914), which was slightly lower than the NT-proBNP-Elecsys assay (AUC 0.922, P=0.006).