OBJECTIVES To determine the diagnostic accuracy of a high-sensitivity cardiac troponin I (hs-cTnI) assay in patients presenting to the Emergency Department (ED) with suspected acute coronary syndromes. Specifically, we evaluated the use of a single blood test at the time of arrival in the ED, using low hs-cTnI cut-offs. METHODS In a prospective diagnostic test accuracy study at 14 centers, we included patients presenting to the ED with suspected ACS within 12 h of symptom onset. We drew blood for hs-cTnI (Siemens ADVIA Centaur, overall 99th percentile 47 ng/L, limit of quantification [LoQ] 2.50 ng/L) on arrival. Patients underwent serial cardiac troponin testing over 3-6 h. The primary outcome was an adjudicated diagnosis of acute myocardial infarction (AMI). We evaluated the incidence of major adverse cardiac events (MACE: death, AMI or revascularization) after 30 days. Test characteristics for hs-cTnI were calculated using previously reported cut-offs set at the LoQ and 5 ng/L. RESULTS We included 999 patients, including 131 (13.1%) with an adjudicated diagnosis of AMI. Compared to the LoQ (100.0% sensitivity [95% CI 95.9-100.0%]), 99.7% negative predictive value [NPV; 95% CI 97.6-100.0%]), a 5 ng/L cut-off had slightly lower sensitivity (99.2%; 95% CI 95.8-100.0%) and similar NPV (99.8%; 95% CI 98.6-100.0%) but would rule out more patients (28.6% at the LoQ vs 50.4% at 5 ng/L). MACE occurred in 2 (0.7%) patients with hs-cTnI below the LoQ and 7 (1.4%) patients with hs-cTnI < 5 ng/L. Accounting for time from symptom onset or ECG ischemia did not further improve sensitivity. CONCLUSION The Siemens ADVIA Centaur hs-cTnI assay has high sensitivity and NPV to rule out AMI with a single blood test in the ED. At the LoQ cut-off a sensitivity > 99% can be achieved. At a 5 ng/L cut-off it may be possible to rule out AMI for over 50% patients.

中文翻译：

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使用新的高灵敏度肌钙蛋白I检测方法的检测限，对急性心肌梗死进行单项试验排除。

目的确定高敏性心肌肌钙蛋白I（hs-cTnI）检测对急诊科（ED）疑似急性冠脉综合征的患者的诊断准确性。具体来说，我们使用低hs-cTnI截止值评估了到达ED时单次血液检查的使用。方法在14个中心进行的一项前瞻性诊断测试准确性研究中，我们纳入了在症状发作12小时内就诊给ED的可疑ACS患者。我们在抵达时为hs-cTnI（西门子ADVIA半人马座，总99％百分位数47 ng / L，定量限[LoQ] 2.50 ng / L）抽取了血液。患者在3至6小时内接受了系列心肌肌钙蛋白测试。主要结果是对急性心肌梗死（AMI）的诊断性诊断。我们评估了主要不良心脏事件的发生率（MACE：死亡，30天后进行AMI或血运重建）。hs-cTnI的测试特征是使用先前报告的设定为最低检测限和5 ng / L的临界值计算的。结果我们纳入了999例经诊断为AMI的患者，其中131例（13.1％）。与LoQ（灵敏度为100.0％[95％CI 95.9-100.0％]）相比，阴性预测值为99.7％[NPV; 95％CI 97.6-100.0％]，5 ng / L临界值的灵敏度略低（99.2％; 95％CI 95.8-100.0％）和类似的NPV（99.8％; 95％CI 98.6-100.0％），但会排除更多的患者（LoQ为28.6％，而5 ng / L为50.4％）。MACE发生在2例（0.7％）hs-cTnI低于LoQ的患者中，7例（1.4％）患者的hs-cTnI <5 ng / L。从症状发作或心电图缺血起计时间并不能进一步提高敏感性。结论西门子ADVIA Centaur hs-cTnI检测具有很高的灵敏度和NPV，可通过ED中的单次血液检查排除AMI。在最低定量限下，可以实现> 99％的灵敏度。截止浓度为5 ng / L时，有可能排除50％以上患者的AMI。