不同试剂检测血清DBIL的可比性及偏倚性临床研究  

Comparability and Bias Evaluation of Serum DBIL Levels Determined by Different Regents

作　　者：王惠萱[1] 贾雄飞[1] 陈忠明[1] 滕毅[1] 余文婕[1] 唐建国[1] 朱光旭[1] 周洁[1] 

机构地区：[1]解放军昆明总医院检验科,昆明650032

出　　处：《现代检验医学杂志》2010年第4期62-64,共3页Journal of Modern Laboratory Medicine

基　　金：国家高技术研究发展计划（863计划）,编号：2006AA020901,生物和医药领域：生物化学诊断试剂临床研究.

摘　　要：目的 进行国产DBIL（直接胆红素）诊断试剂与进口DBIL诊断试剂对DBIL测定结果的可比性及偏倚评估.方法 按美国标准化实验室委员会文件,即NCCLS EP9-A文件,进行试剂的临床验证研究.本研究分别用国产中生直接胆红素体外诊断试剂和进口罗氏直接胆红素体外诊断试剂在日本OLYMPUS AU5421自动生化分析仪上进行病人血清DBIL检测.以此检验国产DBIL试剂的质量、性能及检验品质.研究以进口罗氏试剂为对照组,国产中生北控生物试剂为实验组.每份标本正序、倒序各测定1次,连测10 d,每天10份,共计100份标本.记录测定结果,做统计学分析.结果 进口罗氏和国产中生两种DBIL检验试剂对临床标本DBIL的检测结果显示,方法内重复性检查DX′1≤4DX′,DY′1≤4DY′,离群点检查Eij≤4E,Eij′≤4E′,线性回归R2=0.999 7,系统误差的估计值及其置信区间｜Clow,Chigh｜＜允许误差,系统误差符合临床要求.结论 国产中生北控生物科技股份有限公司DBIL诊断试剂与进口罗氏诊断公司DBIL诊断试剂分别对DBIL进行测定时,两者间具有良好的可比性和相关性.Objective To evaluate the comparability and the bias of serum DBIL（Direct Bilirubin） results determined by do- mestic DBIL diagnostic reagent and imported diagnostic reagent. Methods According to the NCCLS EPg-A document,ten serum samples with high-,middle- and low-DBIL value were selected and the control group was determined by the imported Roche Diagnostic reagent, the experimental group was detected by the domestic Zhongsheng diagnostic reagent. The DBIL determination of each sample was carried out by OLYMPUS AU5421 automatic biochemical analyzer in order and reverse order with Zhongsheng DBIL reagent and Roche DBIL reagent respectively. All the 100 patient samples were analyzed in 10 continuous working days. Results About the two types of DBIL diagnostic reagent,Roche and Zhongsheng,the DBIL detection of clinical specimens showed that the repetitive inspections within methods were DX＇1≤4DX ,and DY1≤4DY. Outlier checks were Eij≤4E and Eij≤4Ei. Linear regression R2 = 0. 991 9. Systematic error estimates and confidence interval ｜Bcivw,Bchigh ｜ were less than Permissible error and Systematic error was in line with the clinical requirements. Conclusion There was a well comparability and positive correlation between the results of DBIL determined by the domestic BIOSINO BIO Technology Co. DBIL diagnostic reagent and roche diagnostics corporation DBIL diagnostic reagent.

关 键 词：直接胆红素 诊断试剂 可比性 偏倚评估 

分 类 号：R446.112[医药卫生—诊断学]