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Ultrio plus和Ultrio核酸检测体系的HBV检出效果评价 被引量:1

Efficiency of Procleix Ultrio plus assay in detecting HBV in blood donors compared with Procleix Ultrio Assay
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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HBsAg-/NAT+和HBsAg+/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McNemartest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121315份,2015年12月1日-2016年4月30日间Ultrio plus筛查标本24909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1:4044(P〈0.05);对于HBsAg+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+/HBsAg-组和85份NAT-/HBsAg+组筛选标本,Ultrio plus的检出能力也明显优于Ultrio(P〈O.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.
作者 邓雪莲 周璐 邹亚轩 高慧卉 陈辉 臧亮 梁晓华 DENG Xuelian, ZHOU Yaxuan, GAO Huihui, ZHOU Lu, WANG Dong, ZANG Liang, LIANG Xiaohua. (Dalian Blood Center, Dalian 116001, China. )
机构地区 大连市血液中心
出处 《中国输血杂志》 北大核心 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)
关键词 HBV DNA 血液筛查 核酸检测 检测能力评价 HBV DNA blood screening nucleic acid testing detecting capability evaluation
作者简介 共同通信作者:邓雪莲(1974.12-),女,主任技师,研究方向为输血相关传染性疾病的风险评估,电话:0411-82653557,Email:dengxuelian@dlbe.org.cn 共同通信作者:梁晓华(1968.07-),女,主任技师、教授,硕士研究生导师,主要从事血液免疫和血液安全的研究,电话:0411-82654596,Email:liangxh@dl.cn
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  • 1刘宇宁,伍晓菲,贾尧,蔡菊英,刘晓音,王迅.乙型肝炎病毒表面抗原血液复查阳性结果确认方案的研究[J].临床输血与检验,2011(4):303-306. 被引量:15
  • 2Niederhausera C,Taleghani BM,Graziani M,et al.Blood donorscreening:how to decrease the risk of transfusion-transmitted hepa-titis B virusSwiss Med Wkly,2008,138(9-10):134-141. 被引量:1
  • 3Yugi H,Mizui M,Anaka J,et al.Hepatitis B Virus(HBV)screeningstrategy to ensure the safety of blood for transfusion through a combi-nation of immunological testing and nucleic acid amplification testing-Japanese experience.J Clinical Virol2,0063,6(Suppl 1):S56-64. 被引量:1
  • 4Busch MP.Transfusion-transmitted viral infections:building bridgesto transfusion medicine to reduce risks and understand epidemiolo-gy and pathogenesis.Transfusion2,006,46(9):1624-1640. 被引量:1
  • 5Delwart E,Kuhns MC,Busch MP.Surveillance of the genetic varia-tion in incident HIV,HCV,and HBV infections in blood and plas-ma donors:implications for blood safety,diagnosticst,reatment,andmolecular epidemiology.J Med Virol,20067,8(Suppl 1):S30-35. 被引量:1
  • 6Laperche S.Blood safety and nucleic acid testing in Europe.EuroSurveill,2005,10(2):3-4. 被引量:1
  • 7Busch MP,Glynn SA,Stramer SL,et al.A new strategy for estimatingrisks of transfusion-transmitted viral infections based on rates of detec-tion of recently infected donors.Transfusion2,0054,5(2):254-264. 被引量:1
  • 8Alvarez M,Oyonarte S,Rodríguez PMe,t al.Estimated risk of trans-fusion-transmitted viral infections in Spain.Transfusion,2002,42(8):994-998. 被引量:1
  • 9Coleman PF.Detecting hepatitis B surface antigen mutants.Emer-ging Infect Dis,2006,12(2):198-203. 被引量:1
  • 10Nantachit N,Thaikruea L,Thongsawat S,et al.Evaluation of a mul-tiplex human immuno-deficiency virus-Ie,patitis C virusa,nd hep-atitis B virus nucleic acid testing assay to detect viremic blood do-nors in northern Thailand.Transfusion,20074,7(10):1803-1807. 被引量:1

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