Body Richard, Morris Niall, Collinson Paul
Emergency Department, Central Manchester University Hospitals NHS Foundation Trust, Oxford Road, Manchester M13 9WL, United Kingdom; Cardiovascular Sciences Research Group, The University of Manchester, Manchester Academic Health Science Centre, Oxford Road, Manchester M13 9PL, United Kingdom; Healthcare Sciences Department, Manchester Metropolitan University, Oxford Road, Manchester, United Kingdom.
Emergency Department, Central Manchester University Hospitals NHS Foundation Trust, Oxford Road, Manchester M13 9WL, United Kingdom; Cardiovascular Sciences Research Group, The University of Manchester, Manchester Academic Health Science Centre, Oxford Road, Manchester M13 9PL, United Kingdom.
Clin Biochem. 2020 Apr;78:4-9. doi: 10.1016/j.clinbiochem.2020.02.014. Epub 2020 Mar 2.
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.
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.
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.
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.
确定高敏心肌肌钙蛋白I（hs-cTnI）检测对急诊科（ED）疑似急性冠脉综合征患者的诊断准确性。具体而言，我们评估了在患者抵达ED时进行单次血液检测，并采用低hs-cTnI临界值的情况。
在一项于14个中心开展的前瞻性诊断试验准确性研究中，我们纳入了症状发作12小时内到ED就诊的疑似急性冠脉综合征患者。患者抵达时采集血液检测hs-cTnI（西门子ADVIA Centaur检测法，总体第99百分位数为47 ng/L，定量限[LoQ]为2.50 ng/L）。患者在3 - 6小时内接受了系列心肌肌钙蛋白检测。主要结局是经判定的急性心肌梗死（AMI）诊断。我们评估了30天后主要不良心脏事件（MACE：死亡、AMI或血运重建）的发生率。hs-cTnI的检测特征是使用先前报告的设定在LoQ和5 ng/L的临界值计算得出的。
我们纳入了999例患者，其中131例（13.1%）经判定诊断为AMI。与LoQ（灵敏度100.0% [95% CI 95.9 - 100.0%]，阴性预测值[NPV] 99.7% [95% CI 97.6 - 100.0%]）相比，5 ng/L的临界值灵敏度略低（99.2%；95% CI 95.8 - 100.0%），NPV相似（99.8%；95% CI 98.6 - 100.0%），但能排除更多患者（LoQ时为28.6%，5 ng/L时为50.4%）。hs-cTnI低于LoQ的患者中有2例（0.7%）发生MACE，hs-cTnI < 5 ng/L的患者中有7例（1.4%）发生MACE。考虑症状发作时间或心电图缺血情况并未进一步提高灵敏度。
西门子ADVIA Centaur hs-cTnI检测法在ED中通过单次血液检测排除AMI具有高灵敏度和NPV。在LoQ临界值时可实现灵敏度> 99%。在5 ng/L临界值时，有可能为超过50%的患者排除AMI。
