Koechlin Luca, Boeddinghaus Jasper, Lopez-Ayala Pedro, Nestelberger Thomas, Wussler Desiree, Mais Felix, Twerenbold Raphael, Zimmermann Tobias, Wildi Karin, Köppen Anne Marie, Miró Òscar, Martin-Sanchez F Javier, Kawecki Damian, Geigy Nicolas, Keller Dagmar I, Christ Michael, Buser Andreas, Giménez Maria Rubini, Bernasconi Luca, Hammerer-Lercher Angelika, Mueller Christian
Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Basel, Switzerland; Department of Cardiac Surgery, University Hospital Basel, University of Basel, Basel, Basel, Switzerland; GREAT network, Basel, Basel, Switzerland.
Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Basel, Switzerland; GREAT network, Basel, Basel, Switzerland; Division of Internal Medicine, University Hospital Basel, University of Basel, Basel, Basel, Switzerland; BHF/University Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.
Am Heart J. 2023 Jan;255:58-70. doi: 10.1016/j.ahj.2022.10.007. Epub 2022 Oct 13.
We aimed to assess the diagnostic utility of the Dimension EXL LOCI High-Sensitivity Troponin I (hs-cTnI-EXL) assay.
This multicenter study included patients with chest discomfort presenting to the emergency department. Diagnoses were centrally and independently adjudicated by two cardiologists using all available clinical information. Adjudication was performed twice including serial measurements of high-sensitivity cardiac troponin (hs-cTn) I-Architect (primary analysis) and serial measurements of hs-cTnT-Elecsys (secondary analysis) in addition to the clinically used (hs)-cTn. The primary objective was to assess and compare the discriminatory performance of hs-cTnI-EXL, hs-cTnI-Architect and hs-cTnT-Elecsys for acute myocardial infarction (MI). Furthermore, we derived and validated a hs-cTnI-EXL-specific 0/1h-algorithm.
Adjudicated MI was the diagnosis in 204/1454 (14%) patients. The area under the receiver operating characteristics curve for hs-cTnI-EXL was 0.94 (95%CI, 0.93-0.96), and comparable to hs-cTnI-Architect (0.95; 95%CI, 0.93-0.96) and hs-cTnT-Elecsys (0.93; 95%CI, 0.91-0.95). In the derivation cohort (n = 813), optimal criteria for rule-out of MI were <9ng/L at presentation (if chest pain onset >3h) or <9ng/L and 0h-1h-change <5ng/L, and for rule-in ≥160ng/L at presentation or 0h-1h-change ≥100ng/L. In the validation cohort (n = 345), these cut-offs ruled-out 56% of patients (negative predictive value 99.5% (95%CI, 97.1-99.9), sensitivity 97.8% (95%CI, 88.7-99.6)), and ruled-in 9% (positive predictive value 83.3% (95%CI, 66.4-92.7), specificity 98.3% (95%CI, 96.1-99.3)). Secondary analyses using adjudication based on hs-cTnT measurements confirmed the findings.
The overall performance of the hs-cTnI-EXL was comparable to best-validated hs-cTnT/I assays and an assay-specific 0/1h-algorithm safely rules out and accurately rules in acute MI.
ClinicalTrials.gov number, NCT00470587.
我们旨在评估Dimension EXL LOCI高敏肌钙蛋白I（hs-cTnI-EXL）检测的诊断效用。
这项多中心研究纳入了因胸部不适前往急诊科就诊的患者。由两位心脏病专家使用所有可用临床信息进行集中且独立的诊断判定。判定进行了两次，除了临床使用的（高敏）肌钙蛋白外，还包括高敏心肌肌钙蛋白（hs-cTn）I-Architect的系列测量（主要分析）和hs-cTnT-Elecsys的系列测量（次要分析）。主要目的是评估和比较hs-cTnI-EXL、hs-cTnI-Architect和hs-cTnT-Elecsys对急性心肌梗死（MI）的鉴别性能。此外，我们推导并验证了一种hs-cTnI-EXL特异性的0/1小时算法。
判定为MI的患者有204/1454例（14%）。hs-cTnI-EXL的受试者工作特征曲线下面积为0.94（95%CI，0.93 - 0.96），与hs-cTnI-Architect（0.95；95%CI，0.93 - 0.96）和hs-cTnT-Elecsys（0.93；95%CI，0.91 - 0.95）相当。在推导队列（n = 813）中，排除MI的最佳标准为就诊时<9ng/L（如果胸痛发作>3小时）或<9ng/L且0小时至1小时变化<5ng/L，纳入标准为就诊时≥160ng/L或0小时至1小时变化≥100ng/L。在验证队列（n = 345）中，这些临界值排除了56%的患者（阴性预测值99.5%（95%CI，97.1 - 99.9），敏感性97.8%（95%CI，88.7 - 99.6）），纳入了9%的患者（阳性预测值83.3%（95%CI，66.4 - 92.7），特异性98.3%（95%CI，96.1 - 99.3））。基于hs-cTnT测量进行判定的次要分析证实了这些结果。
hs-cTnI-EXL的总体性能与经过最佳验证的hs-cTnT/I检测相当，且一种检测特异性的0/1小时算法能够安全地排除并准确地纳入急性MI患者。
ClinicalTrials.gov编号，NCT00470587。
