Diagnostic Evaluation of a High-Sensitivity Troponin I Point-of-Care Assay
Diagnostic Evaluation of a High-Sensitivity Troponin I Point-of-Care Assay
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DOI：
10.1373/clinchem.2019.307405
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发表时间：
2019-12-01
影响因子：
9.3
通讯作者：
Zeller, Tanja
中科院分区：
文献类型：
--
作者：
Soerensen, Nils A.;Neumann, Johannes T.;Zeller, Tanja
背景：在世界范围内，越来越多的疑似心肌梗死的患者出现在急诊科。使用即时肌钙蛋白检测可能使这一高危人群更快地做出决策，并减轻急救设施的负担。在这里，我们评估诊断性能的点护理高灵敏度肌钙蛋白1测定。方法：我们进行了一项前瞻性队列研究，纳入了2013年7月至2016年7月就诊于急诊科的疑似心肌梗死患者。在669例患者的衍生数据集中开发了一种高灵敏度肌钙蛋白I即时检测的诊断算法，并在另外610例患者中进行了验证。结果：得出的现场检测0/1小时算法包括：入院肌钙蛋白I < 4 ng/L和0 - 1 h < 3 ng/L用于排除；入院肌钙蛋白I >= 90 ng/L或0 - 1 h >= 20 ng/L用于非st段抬高型心肌梗死的诊断。应用于验证队列显示阴性预测值为99.7% (95% CI, 98.1%-100.0%)， 48.0%的患者被排除，而14.6%的患者被排除，阳性预测值为86.5% （95% CI, 77.6%-92.8%）。即时护理高灵敏度检测的诊断性能与指南推荐使用的实验室高灵敏度肌钙蛋白检测高度相似。结论：基于高灵敏度肌钙蛋白I即时检测的0/1 h诊断算法的临床应用是安全的，其诊断性能与基于实验室的高灵敏度肌钙蛋白I检测相当。(C) 2019美国临床化学协会
BACKGROUND: Increasing numbers of patients are presenting worldwide to emergency departments with suspected myocardial infarction. The use of point-of-care troponin assays might enable faster decision-making in this high-risk population and reduce the burden on emergency facilities. Here, we evaluate the diagnostic performance of a point-of-care high-sensitivity troponin I assay.METHODS: We conducted a prospective cohort study including patients presenting to the emergency department with suspected myocardial infarction from July 2013 to July 2016. A diagnostic algorithm for a high-sensitivity troponin I point-of-care assay was developed in a derivation data set with 669 patients and validated in an additional 610 patients.RESULTS: The derived 0/1 h algorithm for the point-of-care assay consisted of an admission troponin I < 4 ng/L and a delta from 0 h to 1 h < 3 ng/L for rule out and an admission troponin I >= 90 ng/L or a delta from 0 h to 1 h >= 20 ng/L for rule in of non-ST-elevation myocardial infarction. Application to the validation cohort showed a negative predictive value of 99.7% (95% CI, 98.1%-100.0%) and 48.0% of patients ruled out, whereas 14.6% were ruled in with a positive predictive value of 86.5% (95% CI, 77.6%-92.8%). The diagnostic performance of the point-of-care high-sensitivity assay was highly comparable to guideline-recommended use of a laboratory-based high-sensitivity troponin assay.CONCLUSIONS: The clinical application of a 0/1 h diagnostic algorithm based on a high-sensitivity troponin I point-of-care assay is safe, and diagnostic performance is comparable to a laboratory-based high-sensitivity troponin I assay. (C) 2019 American Association for Clinical Chemistry