一种新型国产乙型肝炎病毒核酸定量检测试剂的临床应用效能评价  

Clinical application efficiency of a new type domestic hepatitis B virus nucleic acid quantitative detection kit

作　　者：张志珊[1] 蒋燕成[1] 陈婉花[1] 苏智军[2] ZHANG Zhishan;JIANG Yancheng;CHEN Wanhua;SU Zhijun(Department of Clinical Laboratory,the First Hospital of Quanzhou Affiliated to Fujian Medical University,Quanzhou 360002,Fujian Province,China;Department of Infection,the First Hospital of Quanzhou Affiliated to Fujian Medical University,Quanzhou 360002,Fujian Province,China)

机构地区：[1]福建医科大学附属泉州市第一医院检验科,福建泉州362000 [2]福建医科大学附属泉州市第一医院感染科,福建泉州362000

出　　处：《新乡医学院学报》2020年第7期641-644,共4页Journal of Xinxiang Medical University

基　　金：福建省自然科学基金资助项目(编号:2016Y9065);泉州市高层次人才创新创业项目(编号:2018C067R)。

摘　　要：目的评估一种新型国产磁珠法乙型肝炎病毒(HBV)核酸定量检测试剂的检测效能。方法收集2016年8~12月在福建医科大学附属泉州市第一医院接受乙型肝炎抗病毒治疗或复诊的90例患者的血清,根据HBV DNA载量将患者分为<50×10^3、(50~100)×10^3、(1~9)×10^5、(1~9)×106、(1~9)×10^7、(1~9)×10^8、(1~9)×10^9、(1~9)×10^10、(1~9)×1011 IU·L^-1组,每组10例。应用国产和原装进口罗氏乙型肝炎病毒核酸定量检测试剂盒分别检测各组患者血清样本,评估2种试剂盒的检测一致性;再用2种试剂盒分别检测滴度为1.7×10^7、1.7×106、1.7×10^5、6×10^4 IU·L^-1的世界卫生组织标准化HBV DNA样本各24次,评估2种试剂盒的可溯源性和可重复性;由同一操作者分别使用2种试剂盒进行检测,并从3名操作者中随机抽取1人,隔日对同一样本重复检测3次。结果3名操作者使用2种试剂盒检测的结果比较差异均无统计学意义(P>0.05),2种试剂盒3名操作者间的检测结果比较差异无统计学意义(P>0.05)。同一操作者对2种试剂盒3次检测的结果比较差异均无统计学意义(P>0.05)。2种试剂盒检测HBV DNA标准品的重复性均较好,国产试剂检测的4个滴度的组内相关系数(ICC)值分别为0.80(F=9.12,P<0.05)、0.84(F=10.34,P<0.05)、0.81(F=13.11,P<0.05)和0.85(F=7.32,P<0.05),罗氏试剂检测的4个滴度的ICC值分别为0.95(F=12.11,P<0.05)、0.92(F=9.02,P<0.05)、0.94(F=10.04,P<0.05)、0.92(F=13.44,P<0.05)。Bland-Altman图显示2种试剂盒检测结果差值90%的位点位于95%置信区间参考范围内,2种检验方法一致性良好。结论新型国产磁珠法HBV核酸定量检测试剂盒与罗氏检测试剂盒的临床检测一致性良好,但国产试剂盒检测重复性略低,表明国产试剂盒的临床应用效能已可与临床“金标准”的进口试剂相媲美,在今后的临床实践中有可能替代目前价格较为昂贵的进口试剂。Objective To evaluate the clinical application efficiency of a new type domestic hepatitis B virus(HBV)nucleic acid quantitative detection kit.Methods The serum samples of 90 patients with hepatitis B who received antiviral treatment or follow-up visit in the First Hospital of Quanzhou Affiliated to Fujian Medical University from August to December 2016 were collected.According to HBV DNA load,the patients were divided into<50×10^3,(50-100)×10^3,(1-9)×10^5,(1-9)×106,(1-9)×10^7,(1-9)×10^8,(1-9)×10^9,(1-9)×10^10,(1-9)×1011 IU·L^-1 group,with 10 patients in each group.The Roche and domestic HBV DNA quantitative detection kit were used to detect the serum samples of patients in each group and the detection consistency of the two kits was evaluated.Then the Roche and domestic HBV DNA quantitative detection kit were used to detect the viral load of World Health Organization standard sample of HBV DNA(the titers was 1.7×10^7,1.7×106,1.7×10^5,6×10^4 IU·L^-1)for 24 times and the traceability and repeatability of the two kit were evaluate.The two kits were used by the same operator for detecting the standard sample respectively;one of the three operators was randomly selected to detect the same sample for three times every other day.Results There was no significant difference in the detection result between the two kits which were used by three operators(P>0.05);there was no significant difference in the detection results among the three operators of the two kits(P>0.05).There was no significant difference in the three detection results of the same operator(P>0.05).The repeatability of the two kits for detecting HBV DNA standard samples was good;the intraclass correlation coefficient(ICC)values of domestic detection kits in detecting the four titers of standard samples were 0.80(F=9.12,P<0.05),0.84(F=10.34,P<0.05),0.81(F=13.11,P<0.05)and 0.85(F=7.32,P<0.05),respectively;the ICC value of Roche detection kit in detecting the four titers of standard samples were 0.95(F=12.11,P<0.05),0.92(F=9.02,P<0.05),0.94(F=1

关 键 词：乙型肝炎 定量检测 一致性 重复性 

分 类 号：R446[医药卫生—诊断学]