Concordance, variance, and outliers in 4 contemporary cardiac troponin assays: implications for harmonization.
Concordance, variance, and outliers in 4 contemporary cardiac troponin assays: implications for harmonization.
复制标题
4 种当代心肌肌钙蛋白测定的一致性、方差和异常值：对协调的影响。
DOI：
10.1373/clinchem.2011.175059
复制
发表时间：
2012
影响因子：
9.3
通讯作者：
C. Pretorius
中科院分区：
文献类型：
--
作者：
J. Ungerer;L. Marquart;P. O’Rourke;Urs Wilgen;C. Pretorius
背景
需要数据来标准化和协调心肌肌钙蛋白检测之间的差异，以支持其在心肌梗死诊断中的普遍地位。我们描述了方法之间的差异、第99百分位数临界阈值的可比性以及4种心肌肌钙蛋白测定中离群值的发生率。
方法
在4个平台上对2358份患者样本进行了心肌肌钙蛋白测定，重复两次：Abbott Architect i2000 SR、Beckman Coulter E12、Roche Cobas e601和Siemens ADVIA Centaur XP。
结果
观察到的3种心肌肌钙蛋白I（cTnI）方法之间以及cTnI和心肌肌钙蛋白T（cTnT）方法之间的总方差大于分析不精密度的预期值（3.0%-3.7%）。cTnI检测试剂之间26%的方法间变异以及cTnI和cTnT检测试剂之间127%的方法间变异是总变异的主要贡献者。根据第99百分位数，cTnI检测试剂之间的结果错误分类为3%-4%，cTnI和cTnT之间的结果错误分类为15%-17%。Roche cTnT检测试剂盒比Abbott cTnI检测试剂盒多识别出49%的阳性样本。Abbott、Beckman Coulter、Roche和Siemens分别在1例患者（0.06%）、8例患者（0.45%）、10例患者（0.56%）和3例患者（0.17%）中检测到方法之间的离群值。
结论
心肌梗死的通用定义不应取决于分析物或分析仪的选择，在这方面应用心肌肌钙蛋白时，需要考虑本文所述的方法间和方法内差异。应说明无法通过分析不精密度解释的方法之间的差异以及根据相应第99次重复测定结果的不一致分类。
BACKGROUND
Data to standardize and harmonize the differences between cardiac troponin assays are needed to support their universal status in diagnosis of myocardial infarction. We characterized the variation between methods, the comparability of the 99th-percentile cutoff thresholds, and the occurrence of outliers in 4 cardiac troponin assays.
METHODS
Cardiac troponin was measured in duplicate in 2358 patient samples on 4 platforms: Abbott Architect i2000SR, Beckman Coulter Access2, Roche Cobas e601, and Siemens ADVIA Centaur XP.
RESULTS
The observed total variances between the 3 cardiac troponin I (cTnI) methods and between the cTnI and cardiac troponin T (cTnT) methods were larger than expected from the analytical imprecision (3.0%-3.7%). The between-method variations of 26% between cTnI assays and 127% between cTnI and cTnT assays were the dominant contributors to total variances. The misclassification of results according to the 99th percentile was 3%-4% between cTnI assays and 15%-17% between cTnI and cTnT. The Roche cTnT assay identified 49% more samples as positive than the Abbott cTnI. Outliers between methods were detected in 1 patient (0.06%) with Abbott, 8 (0.45%) with Beckman Coulter, 10 (0.56%) with Roche, and 3 (0.17%) with Siemens.
CONCLUSIONS
The universal definition of myocardial infarction should not depend on the choice of analyte or analyzer, and the between- and within-method differences described here need to be considered in the application of cardiac troponin in this respect. The variation between methods that cannot be explained by analytical imprecision and the discordant classification of results according to the respective 99th percentiles should be addressed.