Clinical Performance of an N-Terminal Pro-B-Type Natriuretic Peptide Assay in Acute Heart Failure Diagnosis.
Document Type
Article
Publication Date
11-4-2024
Publication Title
The journal of applied laboratory medicine
Abstract
BACKGROUND: We evaluated the Vitros® Immunodiagnostic Products N-terminal pro B-type natriuretic peptide (NT-proBNP) II assay for aiding in diagnosis of heart failure (HF) in patients with acute dyspnea.
METHODS: Serum concentrations of NT-proBNP were measured in patient samples from 20 emergency departments across the United States. Study endpoints included sensitivity, specificity, likelihood ratios, and predictive values for diagnosis of acute HF according to age-stratified cutoffs (450, 900, and 1800 pg/mL), and a rule-out age-independent cutoff (300 pg/mL). Additional measures were area under the curve (AUC) for receiver operating characteristic (ROC) curves. Results were also interpreted in patient subgroups with relevant comorbidities, and gray zone/intermediate assay values.
RESULTS: Of 2200 patients, 1095 (49.8%) were diagnosed with HF by clinical adjudication. Sensitivity and specificity for Vitros NT-proBNP II ranged from 84.0% to 92.1%, and 81.4% to 86.5%, respectively, within and across age groups, and positive predictive values were 80.4% to 85.7%. Using the rule-out cutoff, the negative predictive value was 97.9%, with a negative likelihood ratio of 0.02. In subgroups with comorbidities potentially affecting NT-proBNP concentrations, sensitivities ranged from 82.6% to 89.5%, and AUCs for ROC curves were 0.899 to 0.915.
CONCLUSIONS: The Vitros NT-proBNP II assay demonstrated excellent clinical performance using age-stratified cutoffs along with other clinical information for supporting diagnosis of HF, and can rule out HF with a high negative predictive value using the age-independent cutoff. The assay retained utility in patient subgroups with conditions that influence NT-proBNP concentration, and for those with gray zone results.
CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT03548909.
First Page
jfae107
Recommended Citation
Daniels LB, Ajongwen P, Christenson RH, Clark CL, Diercks DB, Fermann GJ, et al Clinical performance of an n-terminal pro-b-type natriuretic peptide assay in acute heart failure diagnosis. J Appl Lab Med. 2024 Nov 4:jfae107. doi: 10.1093/jalm/jfae107. Epub ahead of print. PMID: 39495056
DOI
10.1093/jalm/jfae107
ISSN
2576-9456
PubMed ID
39495056