Ultrio plus和Ultrio核酸检测体系的HBV检出效果评价  

Efficiency of Procleix Ultrio~ plus assay in detecting HBV in blood donors compared with Procleix Ultrio~ Assay

作　　者：邓雪莲[1] 周璐[1] 邹亚轩[1] 高慧卉[1] 陈辉[1] 臧亮[1] 梁晓华[1] 

机构地区：[1]大连市血液中心,辽宁大连116001

出　　处：《中国输血杂志》2017年第8期897-900,共4页Chinese Journal of Blood Transfusion

基　　金：卫生部医药卫生科技发展研究中心专项课题(卫技中[2012]12号28-8-3);大连市科技计划指导性项目(大科计发[2013]50号);大连市快速提升医疗软实力专项计划(大卫办发[2015]59号)

摘　　要：目的评价Ultrio plus和Ultrio核酸检测体系对HBV的检出效果。方法统计2013年1月1日-2015年12月31日间Ultrio的检测数据和2015年12月1日-2016年4月30日间Ultrio plus的检测数据,比较2种检测体系的单纯NAT初始反应率、鉴别率和和单纯HBV DNA的阳性率;对HBs Ag-/NAT+和HBs Ag+/NAT-2组标本分别采用Ultrio plus和Ultrio进行2次重复联检及1次鉴别试验,比较2者检出率的差异。采用SPSS13.0统计软件,应用Pearson卡方检验和/或Mc Nemar test进行差异性分析。结果 2013年1月1日-2015年12月31日间Ultrio筛查标本121 315份,2015年12月1日-2016年4月30日间Ultrio plus筛查标本24 909份。Ultrio plus的单纯NAT初始反应率、鉴别率及单纯HBV DNA的阳性率依次为1∶461、48.1%和1∶996,显著高于Ultrio的1∶831、21.9%和1∶4 044(P<0.05);对于HBs Ag+标本的核酸检出也由Ultrio检测时间段的78.2%明显提升至95.8%(P<0.05)。对于228份NAT+/HBs Ag-组和85份NAT-/HBs Ag+组筛选标本,Ultrio plus的检出能力也明显优于Ultrio(P<0.05)。结论 Ultrio plus核酸检测体系对大连地区献血者的HBV检出效果明显高于Ultrio;需要探索合理的核酸反应性确认程序和策略以完善献血者的评估。Objective To evaluate the efficiency of Procleix Uhrio plus assay （ Ultrio plus） in detecting HBV in blood donors compared with Procleix Ultrio assay （Ultrio）. Methods Detection data of Ultrio plus between 1st Jan, 2013 and 31th Dec, 2015 and Uhrio between 1st Dec, 2015 and 30th Apr, 2016 were collected, to compare the ratios of NAT initial reactivity （NAT-IR）, discrimination-positive and HBV DNA-yields of Ultrio plus with Ultrio. Two sample groups categorized as HBsAg-/NAT＋ and HBsAg＋/NAT- were retested twice by Uhrio plus and Ultrio and once by companion dis- crimination, respectively. Detection rates of HBV DNA-yield should be analyzed by Fisher＇s Exact test and/or McNemar test with SPSS13.0 statistic soft. Results There were 121 315 samples screened by Uhrio from 1st Jan, 2013 to 31th Dec, 2015 and 24 909 samples by Uhrio from 1st Dec, 2015 and 30th Apr, 2016. The ratios of NAT-IR, discrimination-reactive and HBV DNA-yields of Ultrio plus were 1：461, 48. 1% and 1：996 respectively, obviously higher than those of Uhrio （ 1：831, 21.9% and 1：4 044） （P〈0. 05）. The NAT-yield rate of the former detection of HBsAg carriers increased significantly from 78.2% of the latter screening period to 95.8%. Meanwhile, Ultrio plus also represented remarkable capability in detecting HBV DNA among two sample groups consisting of 228 NAT＋/HBsAg- samples and 85 NAT-/HBsAg＋ samples （P〈0. 05）. Conclusion Ultrio plus having a notable efficiency of HBV detection in blood donors benefits to enhance blood safety c-mpared with Ultrio. It is necessary to develop reasonable procedure and strategy for NAT-IR confirmation to improve donor evaluation.

关 键 词：HBV DNA 血液筛查 核酸检测 检测能力评价 

分 类 号：R457.1[医药卫生—治疗学] R446[医药卫生—临床医学]