Influence of Population Selection on the 99th Percentile Reference Value for Cardiac Troponin Assays
Influence of Population Selection on the 99th Percentile Reference Value for Cardiac Troponin Assays
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DOI：
10.1373/clinchem.2011.171082
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发表时间：
2012-01-01
影响因子：
9.3
通讯作者：
Apple, Fred S.
中科院分区：
文献类型：
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作者：
Collinson, Paul O.;Heung, Yen Ming;Apple, Fred S.
目的：在一个定义明确的参考人群中，我们试图确定患者选择对2个敏感和1个高敏感（hs）心肌肌钙蛋白测定的第99个参考百分位数的影响。方法：从当地7个具有代表性的社区实践中随机抽取年龄在0 ~ 45岁之间的个体。通过问卷收集了参与者的详细信息。健康参考人群定义为没有血管疾病、高血压或大量饮酒史的个体；没有接受心脏药物治疗；血压< 140/90 mmHg，空腹血糖< 110 mg/dL（约6 mmol/L），估计肌酐清除率> 60 mL.min(-1) (1.73 m(2))(-1)，超声心动图结果显示心功能正常。样品保存在-70℃，直到分析心肌肌钙蛋白I （cTnI）和心肌肌钙蛋白int （cTnT）和n端前b型利钠肽。结果：对545名参与者的初始基线人群应用逐渐严格的人群选择策略，直到根据研究标准剩下的个体完全健康为止，减少了所见异常值的数量，并导致罗氏hs-cTnT检测和敏感的Beckman cTnI检测获得的第99百分位值逐渐下降，但敏感的Siemens Ultra cTnI检测则没有。此外，在基线人群中，hs-cTnT （P = 0.0018）和Beckman cTnI测定（P < 0.0001）发现的性别差异随着更严格的人群选择标准而逐渐减少。结论：参考人群选择策略显著影响肌钙蛋白测定的第99百分位参考值以及观察到的肌钙蛋白浓度的性别差异。(C) 2011美国临床化学学会
OBJECTIVE: We sought to determine the effect of patient selection on the 99th reference percentile of 2 sensitive and 1 high-sensitivity (hs) cardiac troponin assays in a well-defined reference population.METHODS: Individuals > 45 years old were randomly selected from 7 representative local community practices. Detailed information regarding the participants was collected via questionnaires. The healthy reference population was defined as individuals who had no history of vascular disease, hypertension, or heavy alcohol intake; were not receiving cardiac medication; and had blood pressure < 140/90 mmHg, fasting blood glucose < 110 mg/dL (approximately 6 mmol/L), estimated creatinine clearance > 60 mL.min(-1).(1.73 m(2))(-1), and normal cardiac function according to results of echocardiography. Samples were stored at -70 degrees C until analysis for cardiac troponin I (cTnI) and cardiac troponinT(cTnT) and N-terminal pro-B-type natriuretic peptide.RESULTS: Application of progressively more stringent population selection strategies to the initial baseline population of 545 participants until the only individuals who remained were completely healthy according to the study criteria reduced the number of outliers seen and led to a progressive decrease in the 99th-percentile value obtained for the Roche hs-cTnT assay and the sensitive Beckman cTnI assay but not for the sensitive Siemens Ultra cTnI assay. Furthermore, a sex difference found in the baseline population for the hs-cTnT (P = 0.0018) and Beckman cTnI assays (P < 0.0001) progressively decreased with more stringent population selection criteria.CONCLUSIONS: The reference population selection strategy significantly influenced the 99th percentile reference values determined for troponin assays and the observed sex differences in troponin concentrations. (C) 2011 American Association for Clinical Chemistry