不同试剂检测血清TBIL的关键技术临床研究  

Comparability and the Bias Evaluation of Serum TBIL Levels Determined by Different Reagents

作　　者：王惠萱[1] 李雪梅[1] 贾雄飞[1] 滕毅[1] 佘文婕[1] 唐建国[1] 周洁[1] 王珂[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5期69-71,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＂生物化学关键试剂临床研究＂课题生物和医药领域.

摘　　要：目的 进行国产TBIL（总胆红素）诊断试剂与进口TBIL诊断试剂对血清TBIL测定结果的可比性及偏倚评估.方法 按NCCLS EP9-A文件,用病人血清标本和国际公认的经过FDA认证的优良试剂作对照,对新研发的国产试剂进行比对研究.本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.每天选择高、中、低值临床血清标本8份,分别用国产中生北控生物有限公司研发的总胆红素体外诊断试剂和进口日本和光生物公司生产的总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总胆红素测定.每份标本正序、倒序各测定1次,连测5 d每天8份,共计40份标本.记录测定结果,做统计学分析.结果 进口和光和国产中生两种TBIL体外诊断试剂对临床标本TBIL的检测结果显示,方法内重复性检查DX′i≤（4DX′）,DY′i≤（4DY′）,离群点检查Eij≤（4E）,Eij＇≤4（E′）,线性回归R2=0.988 9,系统误差的估计值及其置信区间｜（B）Clow,（B）Chigh｜＜允许误差,系统误差符合临床要求.结论 产中生北控生物科技股份有限公司TBIL诊断试剂与进口日本和光公司TBIL诊断试剂分别对TBIL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 total bilirubin （TBIL） results determined by domestic TBIL diagnostic reagent and imported diagnostic reagent. Methods According to the NCCLS EP9-A document, eight serum samples with high-,middle-and low-TBIL value were selected and the TBIL concentrations determination were carried out by OLYMPUS AU5421 automatic biochemical analyzer with Zhongsheng TBIL Reagent and Heguang TEIL Reagent respectively. The control group was Heguang reagent ,the experimental group was Zhongsheng reagent. All the 40 patient samples were analyzed in 5 continuous working days. These results were recorded and statistical analysis was performed. Results Two types of TEIL diagnostic reagent,Heguang and Zhongsheng on detection of clinical specimens TBIL showed that ,methods within the repetitive inspection,DX′i≤（4DX′）,DY′i≤（4DY′）,Outlier checks Eij≤（4E）,Eij＇≤4（E′） ,Linear regression R2= 0. 988 9. Systematic errors estimates and confidence interval｜（B）Clow,（B）Chigh｜〈 Permissible error, systematic errors were in line with the clinical requirements. Conclusion About the determination of the results of TBIL determined by Domestic BIOSINO BIO Technology Co. TBIL Diagnostic Reagent and JAP Heguang Corporation TBIL Diagnostic Reagent, there is a well comparability and positive correlation between the results resulted from two kinds of reagents.

关 键 词：总胆红素 诊断试剂 可比性 偏倚评估 

分 类 号：R446.112[医药卫生—诊断学]