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五种自动化血清皮质醇免疫测定法的性能特征

Performance characteristics of five automated serum cortisol immunoassays.

作者信息

Roberts Richard F, Roberts William L

机构信息

ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT 84108, USA.

出版信息

Clin Biochem. 2004 Jun;37(6):489-93. doi: 10.1016/j.clinbiochem.2004.01.009.

Abstract

BACKGROUND

Serum cortisol measurements are used to help diagnose conditions of cortisol deficiency and excess. Automated, nonisotopic immunoassays are used in most clinical laboratories.

METHODS

Linearity, imprecision, and method comparison studies for serum cortisol assays were performed with the Access, Advia Centaur, AxSYM, Elecsys 2010, and IMMULITE 2000 analyzers.

RESULTS

All methods demonstrated acceptable linearity with the AxSYM method showing the least deviation from target values. The Elecsys 2010 method was the most precise for all three levels of quality control material. Method comparison studies demonstrated good concordance among methods except for two patient samples that gave results on the Elecsys 2010 that were significantly higher than the other methods. Differences in assay calibration were observed.

CONCLUSIONS

Overall, all methods performed well. Additional calibration standardization efforts are required to truly harmonize the results from each assay. The Elecsys 2010 method is less specific than other automated methods based on two discordant patient results.

摘要

背景

血清皮质醇检测用于辅助诊断皮质醇缺乏和过量情况。大多数临床实验室采用自动化非同位素免疫分析法。

方法

使用Access、Advia Centaur、AxSYM、Elecsys 2010和IMMULITE 2000分析仪对血清皮质醇检测进行线性、不精密度和方法比较研究。

结果

所有方法均显示出可接受的线性,AxSYM方法与目标值的偏差最小。Elecsys 2010方法对所有三个质量控制水平的材料最为精确。方法比较研究表明,除两个患者样本外,各方法之间具有良好的一致性,这两个患者样本在Elecsys 2010上的检测结果显著高于其他方法。观察到检测校准存在差异。

结论

总体而言,所有方法表现良好。需要进一步进行校准标准化工作,以真正统一各检测方法的结果。基于两个不一致的患者结果,Elecsys 2010方法的特异性低于其他自动化方法。

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