Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA;
Department of Pathology, University of Maryland, Baltimore, MD.
Clin Chem. 2018 Apr;64(4):645-655. doi: 10.1373/clinchem.2017.277186. Epub 2018 Jan 17.
This document is an essential companion to the third iteration of the National Academy of Clinical Biochemistry [NACB, now the American Association for Clinical Chemistry (AACC) Academy] Laboratory Medicine Practice Guidelines (LMPG) on cardiac markers. The expert consensus recommendations were drafted in collaboration with the International Federation of Clinical Chemistry and Laboratory Medicine Task Force on Clinical Applications of Bio-Markers (IFCC TF-CB). We determined that there is sufficient clinical guidance on the use of cardiac troponin (cTn) testing from clinical practice groups. Thus, in this expert consensus document, we focused on clinical laboratory practice recommendations for high-sensitivity (hs)-cTn assays. This document utilized the expert opinion class of evidence to focus on the following 10 topics: () quality control (QC) utilization, () validation of the lower reportable analytical limits, () units to be used in reporting measurable concentrations for patients and QC materials, () 99th percentile sex-specific upper reference limits to define the reference interval; () criteria required to define hs-cTn assays, () communication with clinicians and the laboratory's role in educating clinicians regarding the influence of preanalytic and analytic problems that can confound assay results, () studies on hs-cTn assays and how authors need to document preanalytical and analytical variables, () harmonizing and standardizing assay results and the role of commutable materials, () time to reporting of results from sample receipt and sample collection, and () changes in hs-cTn concentrations over time and the role of both analytical and biological variabilities in interpreting results of serial blood collections.
本文件是美国临床化学协会（AACC）临床化学实践指南（LMPG）第三版[NACB，现为美国临床化学协会（AACC）学院]关于心脏标志物的重要配套文件。专家共识建议是与国际临床化学和实验室医学联合会生物标志物临床应用工作组（IFCC TF-CB）合作起草的。我们确定，临床实践小组已经有足够的关于心肌肌钙蛋白（cTn）检测使用的临床指导。因此，在本专家共识文件中，我们重点关注高敏（hs）-cTn 检测的临床实验室实践建议。本文件利用专家意见类证据，重点关注以下 10 个主题：（）质量控制（QC）的使用，（）验证可报告的分析下限，（）用于报告患者和 QC 材料可测量浓度的单位，（）定义参考区间的 99 百分位性别特异性上限参考值；（）定义 hs-cTn 检测的标准，（）与临床医生的沟通以及实验室在告知临床医生分析前和分析问题对检测结果的影响方面的作用，（）hs-cTn 检测的研究以及作者如何记录分析前和分析变量，（）协调和标准化检测结果以及可交换材料的作用，（）从样本接收和样本采集到报告结果的时间，（）hs-cTn 浓度随时间的变化以及分析和生物学变异性在解释连续采血结果中的作用。
