五种心脏肌钙蛋白 I 检测方法的性能特征。

Performance characteristics of five cardiac Troponin I assays.

机构信息

ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, United States.

出版信息

Clin Chim Acta. 2010 Aug 5;411(15-16):1095-101. doi: 10.1016/j.cca.2010.04.008. Epub 2010 Apr 14.

DOI:10.1016/j.cca.2010.04.008

PMID:20398643

Abstract

BACKGROUND

The aim of this study was to evaluate the performance characteristics of cardiac Troponin I (cTnI) assays on the Access 2, Advia Centaur, Architect i1000(SR), Architect i2000(SR), and Vitros ECi analyzers.

METHODS

To determine the 99th percentile, plasma and serum samples were drawn from 400 apparently healthy subjects. Functional sensitivity was evaluated by testing 10 panels of serum pools in duplicate for 10days using 2 reagent lots. Imprecision was also assessed using commercial quality control materials. For method comparison, 100 plasma samples were tested by all methods with the Architect i2000(SR) assay as the comparison method.

RESULTS

The 99th percentile ranged from 0.013 to 0.020microg/l. Calculated CVs at the 99th percentile were 23-52%. cTnI concentrations at a 10% CV ranged from 0.039 to 0.101microg/l. Total CVs determined using quality control materials were 2.4-10.0%. Method comparison results by Deming regression had slopes of 1.03-1.51. The mean bias for cTnI samples between 0.01 and 1.0microg/l ranged from 0 to 0.2microg/l.

CONCLUSIONS

No method demonstrated a concentration with a 10% CV that was less than the 99th percentile for healthy adults. All methods compare well to the Architect i2000(SR) assay with the Advia Centaur having the highest positive bias.

摘要

背景

本研究旨在评估心脏肌钙蛋白 I(cTnI)检测试剂盒在 Access 2、Advia Centaur、Architect i1000(SR)、Architect i2000(SR)和 Vitros ECi 分析仪上的性能特征。

方法

为了确定第 99 百分位值，从 400 名貌似健康的个体抽取血浆和血清样本。通过使用 2 个试剂批次重复检测 10 个血清池的 10 个面板，评估功能灵敏度。使用商业质控材料评估精密度。为了方法比较，用所有方法检测 100 个血浆样本，以 Architect i2000(SR)检测方法为比较方法。

结果

第 99 百分位值范围为 0.013 至 0.020μg/l。第 99 百分位值的计算 CV 为 23-52%。10%CV 时 cTnI 浓度范围为 0.039 至 0.101μg/l。使用质控材料确定的总 CV 为 2.4-10.0%。Deming 回归法的方法比较结果斜率为 1.03-1.51。0.01 至 1.0μg/l 之间 cTnI 样本的平均偏差范围为 0 至 0.2μg/l。