两种乙型肝炎病毒核酸定量试剂对315例样本检测结果的比较  

Test results of 315 serum samples by two reagents for quantification of hepatitis B virus DNA

作　　者：吴星[1] 周诚[1] 黄维金[1] 蓝海云[1] 辜文洁[1] 梁争论[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国生物制品学杂志》2013年第8期1151-1153,1160,共4页Chinese Journal of Biologicals

基　　金：十一五专项乙型肝炎质量控制及评价研究(2009ZX-10006-802)

摘　　要：目的采用国内和国外乙型肝炎病毒核酸(HBV DNA)定量检测试剂盒检测315份血清样本,比较两种试剂检测能力的差异。方法采用Abbott Architect i2000化学发光检测试剂盒检测315份样本的乙型肝炎血清学五项指标后,再用进口(简称"Roche试剂")及国产(简称"国产试剂")乙型肝炎病毒核酸定量试剂盒进行复检,比较两种试剂检测结果的一致性。结果两种试剂定性结果阳性符合率为60.6%(134/221),阴性符合率为100%(94/94),总符合率为72.4%,检测结果差异有统计学意义(P<0.01);无论对HBsAg阳性或阴性样本,Roche试剂的阳性检出率均明显高于国产试剂(P均<0.01),灵敏度为导致二者检测结果产生差异的主要原因;定量结果相关性和一致性分析表明,两种试剂定量检测结果有较好的一致性。结论不同试剂盒检测HBV DNA灵敏度差异较大,本实验国产HBV DNA定量试剂盒灵敏度较低,质量有待提高。Objective To test 315 serum samples by domestic and imported reagents for quantification of hepatitis B virus（HBV） DNA and compare the test abilities of two reagents.Methods A total of 315 serum samples were determined for five serological indexes of hepatitis B by using Abbott Architect i2000 chemoluminescent kit,then the HBV DNA results obtained by imported（Roche）and domestic kits were compared.Results The positive and negative coincidence rates of Roche and domestic reagents were 60.6%（134 / 221）and 100%（94 / 94）,respectively,while the total coincidence rate was 72.4%,indicating a significant difference（P 0.01）.The positive rates of both HBsAg-positive and-negative samples confirmed by Roche reagent were significantly higher than those by domestic reagent（both P 0.01）,which was mainly due to the sensitivities of the two reagents.However,the quantification results by the two reagents showed high consistence.Conclusion Compared with imported reagent,the domestic HBV DNA quantification reagent used in this study showed low sensitivity,of which the quality should be further improved.

关 键 词：肝炎病毒 乙型 核酸 荧光定量 

分 类 号：R373.21[医药卫生—病原生物学] R446.1[医药卫生—基础医学]