Departments of Medicine and.
Clin Chem. 2014 Mar;60(3):455-62. doi: 10.1373/clinchem.2013.211706. Epub 2013 Oct 10.
How to select a presumably normal population for the establishment of 99th percentile cutoffs for cardiac troponin assays has not been adequately addressed. Lack of attention to this question can result in misleading medical decision cutoffs.
From our review of the peer-reviewed literature, including international recommendations, no uniform procedure is followed and no uniform guideline has been published by experts or regulatory agencies to guide researchers or manufacturers of cardiac troponin assays in their quest to define the health or "normality" of a reference population that is used to establish an accurate 99th percentile value. As we progress globally into the era of high-sensitivity cardiac troponin assays, we propose several suggested approaches to define presumably normal individuals by use of clinical and biomarker surrogates.
Our uniform approach to defining who is normal and who may not be normal will help to define diagnostic and risk outcomes assessments in the management of patients with suspected myocardial injury, both for use in current clinical practice and clinical research, as well as for the potential future use of cardiac troponin in primary prevention.
如何选择一个假定的正常人群来建立心脏肌钙蛋白检测的第 99 百分位截断值尚未得到充分解决。如果不重视这个问题，可能会导致误导性的医学决策截断值。
从我们对同行评议文献的审查，包括国际建议中，我们发现没有遵循统一的程序，也没有专家或监管机构发布统一的指南，来指导心脏肌钙蛋白检测的研究人员或制造商，以确定用于建立准确的第 99 百分位值的参考人群的健康或“正常”状态。随着我们在全球范围内进入高敏心脏肌钙蛋白检测时代，我们提出了几种使用临床和生物标志物替代物来定义假定正常个体的建议方法。
我们统一的定义正常人和可能不正常人群的方法，将有助于定义疑似心肌损伤患者的诊断和风险评估结果，不仅用于当前的临床实践和临床研究，也为心脏肌钙蛋白在初级预防中的潜在未来用途提供了帮助。
