两种糖化血红蛋白检测系统的方法学比对和偏倚评估

发布时间：2018-06-10 16:09

本文选题：血红蛋白A + 糖基化　；参考：《实用医学杂志》2009年18期

【摘要】：目的:对日立7170A和DREWDS5糖化血红蛋白分析仪这两种糖化血红蛋白检测方法进行方法学比对和偏倚评估,为实验室提供准确可靠的实验数据。方法:以日立7170A/为参考系统(X),以DREWDS5糖化血红蛋白分析仪为待比系统(Y)。依据美国临床实验室标准化协会EP9-A2文件要求,分别在上述两种检测系统中测定标本糖化血红蛋白浓度,记录检验结果,检查离群点,计算线性方程和相关系数和直线回归方程,以临床实验室改进规范88(CLIA’88)规定的室间质量评价允许误差范围的1/2为标准,在不同医学决定水平判断不同检测系统的偏差于临床是否可以接受。结果:实验方法与参考方法两者相关性良好,二者之间的偏差在临床允许误差内。结论:当使用2个以上检测系统检测同一检验项目时,应进行方法比对和偏倚评估,判断其临床可接受性能,以保证检验结果的可比性。
[Abstract]:Objective: to compare the methods and evaluate the bias between Hitachi 7170A and DREWDS5 glycosylated hemoglobin analyzer, so as to provide accurate and reliable experimental data. Methods: Hitachi 7170A/ was used as reference system and DREWDS 5 glycosylated hemoglobin analyzer was used as reference system. According to the requirements of EP9-A2 documents of the American Association of Clinical Laboratory Standardization, the saccharified hemoglobin concentrations of the samples were measured in the above two testing systems, the test results were recorded, the outliers were checked, and the linear equations, correlation coefficients and linear regression equations were calculated. Based on the standard of 1 / 2 of the allowable error range of the indoor quality evaluation as stipulated in clinical laboratory improvement specification 88 / CLIA88, the deviation of different testing systems is judged to be acceptable in clinical practice at different medical decision levels. Results: there was a good correlation between the experimental method and the reference method, and the deviation between the two methods was within the clinical allowable error. Conclusion: when two or more testing systems are used to detect the same test items, the comparison of methods and bias evaluation should be carried out to judge the clinical acceptability of the test results, so as to ensure the comparability of the test results.
【作者单位】：广东省中医院二沙岛分院检验科;广州医学院06级检验系;
【分类号】：R446.1

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