摘要
目的评价血清总蛋白常规方法与参考方法的一致性,旨在为临床提供准确结果。方法采用血清总蛋白参考方法和常规方法同时测量GBW09186~188、RELA22A、22B、18A、18B、17A、17B、40份单人份血清样本,参考EP9-A3,将两种方法检测结果进行比对;参考EP14-A3文件,对常规方法使用的校准品进行互换性分析。结果参考方法测量标准物质和比对样本的偏倚为-1.66%~0.51%,常规方法测量偏倚为-2.34%~-0.30%,参考方法偏倚均小于常规方法。Bland-Altman图所有数据均匀地分布在均值附近且大部分(41/43)在95%置信区间(CI)内,说明两种方法有良好的一致性。3种回归分析中45g/L医学决定水平处的偏倚大于临床可接受范围,其余医学决定水平处的偏倚均小于临床可接受范围。常规方法使用的校准品测量值和其预测值的偏倚分别为1.23%、-1.65%,2个校准品均超出95%CI,校准品无互换性。结论血清总蛋白常规方法存在系统误差,且在低值处的正确度略有偏差。
Objective To evaluate the consistency of serum total protein routine methods with the reference method,in order to provide more accurate results for the clinical practice.Methods Serum total protein reference method and conventional method were applied to measure GBW09186-188,RELA22A,22B,18A,18B,17A,17B and 40 individual serum samples.According to EP9-A3,the detection results of the two methods were compared.An interchangeability analysis of the calibrators used by conventional methods was performed with reference to EP14-A3.Results The bias of the reference method for measuring standard materials and comparison samples was-1.66%-0.51%,while the bias of the conventional method was-2.34%-0.30%.The bias of the reference method was smaller than that of the conventional method.All the data points in the Bland-Altman plot were uniformly distributed around the mean value and very high percentage of them(41/43)were within 95%confidence interval,indicating a good consistency between the two methods.Based on results of the three regression analyses,the bias at the 45g/L medical decision level was greater than the clinically acceptable range,and the bias at the other medical decision levels was smaller than the clinically acceptable range.The bias between the measured value and the predicted value of the calibrators used in the conventional method was 1.23%and-1.65%,respectively.Both calibrators exceeded 95%CI,and the calibrators were not interchangeable.Conclusion The conventional method for serum total protein shows systematic errors,and there is a slight deviation in accuracy at low values.
作者
孙江漫
孟祥兆
李敏
邵燕
尹显艳
于洪远
SUN Jiangman;MENG Xiangzhao;LI Min;SHAO Yan;YIN Xianyan;YU Hongyuan(Beijing Aerospace General Hospital Clinical Laboratory,Beijing 100076)
出处
《标记免疫分析与临床》
CAS
2024年第5期927-930,共4页
Labeled Immunoassays and Clinical Medicine
作者简介
孙江漫(1990-),女,硕士研究生,主管技师,主要从事临床化学标准化研究;通讯作者:于洪远,副主任技师,主要从事科研教学、生化免疫检验及标准化。
