荧光定量PCR检测HBV-DNA室内质控物的制备及初步应用  

Preparation and Clinical Application of Internal Quality Control Substance of HBV DNA by Real Time Quantitative PCR

作　　者：姚磊[1] 韩艳辉[1] 罗富康[1] 张征[1] 康铃[1] 

机构地区：[1]重庆第三军医大学新桥医院检验科,重庆400037

出　　处：《中国误诊学杂志》2006年第5期807-809,共3页Chinese Journal of Misdiagnostics

摘　　要：目的:制备HBV-DNA荧光定量PCR检测的室内质控物,并对其应用价值进行初步评价。方法:留取单一乙肝模式的混合血清样本,并用正常人血清将收集的血清稀释至所需的浓度,用与待检血清相同的仪器、同一品牌的HBV-DNA定量试剂盒进行检测,确定其靶值,计算x-、s、CV,绘制质控图。结果:自制的室内质控物高低值的变异范围分别为1.10%、1.01%(CV<5%),稳定性好。结论:临床实验室可以用单一乙肝模式的混合血清制备HBV-DNA定量检测的质控物,其制备容易,测定结果稳定,有一定的临床实用价值。Objective： To develop an internal quality control substance of HBV-DNA by real time quantitative PCR and to evaluate its clinical value. Methods： HBsAg, HBeAg, anti HBe, HBsAg, anti-HBe, anti-HBc positive sera were collected as materials, then diluted using normal sera. Then the inter assay coefficient of variation （CV） was determined by the same instrument and the same brand of kits. Results： The inter assay CV ranges of high and low levels for internal quality control substance were 1.10% and 1.01% （CV〈5%） respectively, and the stability was fine. Conclusion： The internal quality control substance of HBV-DNA is applicable in clinical laboratory.

关 键 词：肝炎病毒 乙型/遗传学 DNA 病毒/分析 聚合酶链反应 

分 类 号：R373.21[医药卫生—病原生物学]