检验医学 ›› 2012, Vol. 27 ›› Issue (12): 1058-1061.

• 生物化学检验论著 • 上一篇    下一篇

替代方法评价两种检测系统测定糖化血清蛋白结果的一致性

黄永富   

  1. 1.扬州大学第四临床医学院南通瑞慈医院检验医学中心,江苏 南通 226010;2.南通市临床检验中心,江苏 南通226000
  • 收稿日期:2012-10-08 出版日期:2012-12-30 发布日期:2012-12-04
  • 作者简介:黄永富,男,1971年生,硕士,副主任技师,主要从事临床检验诊断学和质量控制技术研究。

  Evaluation on consistency of glycosylated serum protein testing results between two biochemical analytical systems

  1. 1. Thefourth Clinical Medical College Affiliated to Yangzhou University,Department of Clinical Laboratory,Nantong Rich Hospital,Jiangsu Nantong 226010,China;2.Laboratory Medicine Center of Nantong City,Jiangsu Nantong 226000,China
  • Received:2012-10-08 Online:2012-12-30 Published:2012-12-04

摘要:   目的 评价德灵和奥林巴斯2种生化检测系统间糖化血清蛋白(GSP)测定结果的一致性。 方法 分别校准用于测定GSP的德灵和奥林巴斯2种检测系统,并在该分析批内确认室内质控在控。根据美国临床实验室标准化协会(CLSI)GP29-A文件要求分割实验样本,收集患者血清后一分为二,在2种检测系统上分别对室间质评中不能提供能力验证(PT)的检测项目GSP进行双份测定,分析浓度尽可能分布于检测项目方法的整个检测范围内,最后计算2种检测系统检测结果的均值(〖AKx-D〗)、均值的差值(d)及允许差异值(D),判断2种检测系统是否能得出一致性的结果。 结果 奥林巴斯检测系统上GSP检测结果均落在德灵检测系统的允许差异值范围(〖AKx-D〗±D)内。2种检测系统在1.0~16.0 mmol/L范围内测定GSP的相关性良好,其结果一致性可以接受。 结论 德灵和奥林巴斯2种检测系统测定GSP的结果基本一致,临床上可任选1种用于GSP测定。对于目前暂没开展室间质评计划的项目,根据CLSI GP29-A文件进行样本分割实验(SST)并评价检测结果的一致性,是一种评价2种检测系统结果一致性方便而快捷的手段。

关键词: 糖化血清蛋白, 样本分割实验, 检测系统, 结果一致性

Abstract:   Objective To evaluate the consistency of glycosylated serum protein(GSP) testing results between 2 biochemical analytical systems,Dada and Olympus. Methods Each biochemical analytical system was separately calibrated and ensured the daily internal quality control under control limits. According to Clinical and Laboratory Standards Institute(CLSI) GP29-A document,the split-sample testing(SST) was carried on. Each serum sample,whose concentration was selected in the methodology measurable range,was divided into 2 parts and made duplicate testingfor GSP,which could notprovide proficiency testing(PT) on external quality assessment,on the each biochemical analytical system. The mean(〖AKx-D〗),difference(d) and allowable difference values(D) werefinally calculated to evaluate the results′ consistency. Results The GSP results on Olympus detection system were within the allowable differences of Dade detection system(〖AKx-D〗±D).Two biochemical analytical systems had good correlation of GSP testing in the concentration rangefrom 1.0 mmol/L to 16.0 mmol/L,and their results′ consistency was accepted. Conclusions All the results could be accepted between the 2 biochemical analytical systems,and one of them could be selected to testGSP. SSTis a convenientandfastalternative assessmentprocedure to evaluate the consistencyfor GSP testing results,whose proficiency testing is notavailable atpresent.

Key words: Glycosylated serum protein, Split-sample testing, Analytical system, Resultconsistency