Daniels Lori B, Ajongwen Patience, Christenson Robert H, Clark Carol L, Diercks Deborah B, Fermann Gregory J, Mace Sharon E, Mahler Simon A, Pang Peter S, Rafique Zubaid, Runyon Michael S, Tauras James, deFilippi Christopher R
Department of Medicine, University of California, San Diego, La Jolla, CA, United States.
Department of Biostatistics & Clinical Data Management/Science, QuidelOrtho Corporation, Raritan, NJ, United States.
J Appl Lab Med. 2025 Mar 3;10(2):325-338. doi: 10.1093/jalm/jfae107.
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.
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.
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.
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.
我们评估了维特洛斯®免疫诊断产品N末端B型利钠肽原（NT-proBNP）II检测法在急性呼吸困难患者心力衰竭（HF）诊断中的辅助作用。
在美国20个急诊科的患者样本中检测NT-proBNP的血清浓度。研究终点包括根据年龄分层临界值（450、900和1800 pg/mL）以及排除年龄无关临界值（300 pg/mL）诊断急性HF的敏感性、特异性、似然比和预测值。其他指标为受试者操作特征（ROC）曲线的曲线下面积（AUC）。还对有相关合并症的患者亚组以及灰色区域/检测值处于中间范围的情况进行了结果解读。
在2200例患者中，经临床判定1095例（49.8%）被诊断为HF。维特洛斯NT-proBNP II检测法在各年龄组内及不同年龄组间的敏感性范围为84.0%至92.1%，特异性范围为81.4 %至86.5%，阳性预测值为80.4%至85.7%。使用排除临界值时，阴性预测值为97.9%，阴性似然比为0.02。在可能影响NT-proBNP浓度的合并症亚组中，敏感性范围为82.6%至89.5%，ROC曲线的AUC为0.899至0.915。
维特洛斯NT-proBNP II检测法使用年龄分层临界值及其他临床信息支持HF诊断时表现出优异的临床性能，并且使用与年龄无关的临界值可高阴性预测值排除HF。该检测法在影响NT-proBNP浓度的疾病患者亚组以及检测结果处于灰色区域的患者中仍有用处。
NCT03548909。
