常规方法检测血清总胆红素的正确度评价  

Accuracy evaluation of the routine method detected serum total bilirubin

作　　者：徐建华[1] 庄俊华[1] 郑松柏[1] 徐宁[1] 陈丹娜[1] 王建兵[1] 柯培锋[1] 陈鹏飞[1] 黄宪章[1] 

机构地区：[1]广东省中医院检验医学部,广州510120

出　　处：《临床检验杂志》2012年第12期946-949,共4页Chinese Journal of Clinical Laboratory Science

基　　金：国家重大新药创制专项(中药新药临床实验室评价技术平台研究)(2008ZX09312);广东省医学科学技术研究基金项目(A2010218);"十二五"国家科技支撑计划项目(2012BAI37B01)

摘　　要：目的探讨并比较常规方法检测血清总胆红素(T-Bil)的正确度的评价方法。方法参照CLSI EP15-A2文件,用常规方法测定有证参考物质、国际参考实验室室间比对计划(RELA)样本、卫生部临床检验中心室间质评样本T-Bil水平,用BioRad Unity实验室室间质评数据分析本实验室与对等组和方法组间的偏移及标准差指数(SDI),与参考方法比对等方案评估常规测量T-Bil的正确度。结果 NIST SRM 909b参考物质、2010～2011年RELA样本、2012年卫生部临检中心第1次室间质评样本测定结果均在可接受范围内。2012年1～6月Unity实验室间质评数据结果偏移及SDI指数均满足要求。与参考方法比对结果相关性好(Y=1.129 9X-5.734 3,r=0.999 8),小于300μmol/L时,偏移可接受;大于300μmol/L时,偏移较大(10%～13%),不可接受。用去离子水稀释5倍使其浓度约达到50～100μmol/L后重测,偏移可接受,满足临床需要。结论 "单点浓度"的正确度评价具有局限性,临床实验室应分析全测量范围内的正确度情况,与参考方法比对是实现常规测量正确度评价的有效方法之一。Objective To explore the evaluation method of accuracy of the routine method for detection of serum total biliiubin （T- Bil）. Methods According to the CLSI EP15-A2 documents, the T-Bil levels of samples for reference materials, IFCC Ring Trials for Reference Laboratories （RELA）, and external quality assessment from National Center of Clinical Laboratories were detected by the routine method. The biases and standard deviation index （SDI） between the routine method and the same method group from Bio Rad Unity laboratory quality assessment platform were analyzed, and the accuracy of the routine method was evaluated and compared with the reference method. Results The T-Bil levels of RELA samples （2010 - 2011 ）, NIST SRM 909b reference materials, and samples for external quality assessment （the first time in 2012） from National Center of Clinical Laboratories detected by the routine method were all acceptable. The biases and SDI were also acceptable when compared with the data （January to June, 2012） from Bio-Rad U- nity laboratory quality assessment platform. There was well correlation between the routine method and the reference method （ Y = 1. 129 9X -5. 734 3, r = 0. 999 8）. When the concentration of T-Bil was less than 300 μmol/L, the bias could be accepted. Howev- er, when the T-Bil concentration was more than 300 μmol/L, the biases were from 10% to 13%, and could not be accepted. After the samples with high concentration of T-Bil were diluted 5 times with deionized water and redetected, the biases could be accepted and met the clinical requirement. Conclusion The accuracy evaluation of ＂single point concentration＂ had its limitations. In clinical la- boratories, the accuracy of the whole measurement range should be analyzed, and the comparison with the reference method was one of valid methods to perform the accuracy evaluation of the routine method.

关 键 词：总胆红素 可比性 正确度 参考方法 

分 类 号：R446.1[医药卫生—诊断学]