罗氏Modular P800型生化分析仪测量总胆红素的方法学性能评价及参考区间的建立  

Evaluation of the Method for Determination of Total Bilirubin with Roche Modular P800 Biochemistry Analyzer and Establishment of the Reference Intervals

作　　者：王建兵[1] 潘婉仪[1] 徐建华[1] 郭龙华[1] 孙蕾[1] 黄宪章[1] 梁伟雄[1] 庄俊华[1] 

机构地区：[1]广东省中医院检验科,广州510120

出　　处：《现代检验医学杂志》2009年第1期81-83,共3页Journal of Modern Laboratory Medicine

基　　金：国家科技支撑计划项目（2006BA114B00）子项目.

摘　　要：目的通过对罗氏Modular P800生化分析仪检测血清总胆红素（TBIL）的方法学性能评价和建立参考区间的研究，探讨临床化学定量检测的方法学性能评价方案和实验方法。方法取罗氏正常水平质控和病理水平质控物，分别进行批内20次和连续20d总胆红素的检测，统计分析批内变异（Cy）和日间CV；将高、低值血清按一定比例混合，检测TBIL，回归分析确定分析测量范围（AMR）；将中值血清按一定比例稀释后检测TBIL，分析稀释后样本测量值和预期结果的符合程度，得出临床可报告范围（CRR）；回顾分析376名健康人群血清样本TBIL的检测结果，统计分析建立参考区间。结果正常水平、病理水平质控批内CV分别为0．63％，0．58％；日间CV分别为2．46％，1．68％；AMR为0．5～741．0μmol／L；CRR为0．5～59280μmol／L；TBIL的参考区间为2．1～22．3μmol／L。结论Modular系统检测性能能满足临床要求，评价方案简单易行；参考区间与厂家提供的参数不同，说明厂家提供的参考区间不可直接引用。Objective To study the evaluation on method performance for determination of total bilirubin with Roche Modular P800 biochemistry analyzer and establish the reference intervals of TBIL,in order to explore a method performance evaluation project and experimental method for clinical chemistry quantity assays. Methods The within-run and betweenday coefficient of variation（CV） were performed with roche normal and pathologic level controls. The analytic measurement range（AMR） was determined with mixed serum. The level of TBIL in middle level serum was detected after diluted according to a specific ratio. The clinical reportable range（CRR） was established according to the coincidence degree of sample before and after dilution. The reference interval of TBIL was established with 376 normal peoples. Results The CV of within day for roche normal and pathologic level controls was 0. 63% and 0. 58%,the CV of between-day was 2. 46% and 1.68% AMR was 0. 5-741.0 μmol/L;CRR was 0.5-59 280 μmol/L;the reference intervals was 2.1-22.3 μmol/L. Conclusions The system measurement characteristics can satisfy the requirement of clinic. Reference intervals is not coincidence with reference intervals which provided by manufactory. Which indicate the manufacturers instruction can not be directly used in laboratory.

关 键 词：总胆红素 参考区间 分析测量范围 

分 类 号：R446[医药卫生—诊断学]