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临床输血与检验

临床输血与检验 ›› 2016, Vol. 18 ›› Issue (1): 66-70.DOI: 10.3969/j.issn.1671-2587.2016.01.020

• 调查研究 • 上一篇    下一篇

MPX V2.0试剂在血液核酸筛查中的应用

高犁,钱惠忠,许友山,胡越,夏卫   

  1. 214000 江苏省无锡市中心血站检验科
  • 收稿日期:2015-08-12 出版日期:2016-02-20 发布日期:2016-10-10
  • 作者简介:高犁（1985–）,男,江苏无锡人,检验师,硕士,主要从事感染与免疫、分子免疫研究,（Tel）18626385322（E-mail）253183992@qq.com。

Application of MPX V2.0 Reagent to Blood DNA Screening in Wuxi

GAO Li, QIAN Hui-Zhong, XU You-Shan, HU Yue, et al   

  1. Wuxi Red Cross Blood Center,Wuxi 214003
  • Received:2015-08-12 Online:2016-02-20 Published:2016-10-10

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摘要： 目的通过与MPX V1.0试剂的比对,评估罗氏诊断公司MPX V2.0试剂在血液筛查中的可行性和适用性。方法在罗氏Cobas核酸检测平台上,分别使用MPX V1.0或MPX V2.0试剂对9 418人次HBsAg、抗-HCV、抗-HIV、TP ELISA阴性的无偿献血者血液标本进行核酸定性检测,并对NAT阳性样本进行鉴别确认试验和电化学发光检测。结果9 418人次标本经MPX V1.0检出混样阳性样本10例,6例拆分阳性样本,检出总阳性率0.064%;MPX V2.0检出9例混样阳性,6例拆分阳性,检出总阳性率0.064%;MPX V2.0对MPX V1.0,相对阴性符合率99.98%,相对总符合率99.96%;MPX V1.0和MPX V2.0均检测为阳性者4例,MPX1.0和MPX V2.0单独阳性者各2例。用确认试验鉴别4例 HBV DNA 阳性 ,结果1例 HCV RNA阳性,3例不确定;发现1例低CT值（MPX V1.0 CT=16.4,MPX V2.0 CT=18）样本,经MPX V2.0判定为HCV感染,推测为HCV感染窗口期,之后经追踪检测证实。结论MPX V2.0试剂与MPX V1.0试剂拆分率接近,检出总阳性率一致,相对总符合率较高;两种试剂均有对低病毒载量（<20 U/ml）样本的漏检,灵敏度仍待提高;MPX V2.0可直接区分病毒感染类型,更有利于对阳性献血者的解释和追踪随访,以指导其早期就诊。

关键词: 血液安全, 核酸检测, 血液筛查, MPX, V2.0试剂

Abstract: ObjectiveTo assess the feasibility and applicability of roche diagnostics MPX V2.0 in screening of blood nucleic acid technology(NAT) by its comparison with MPX V1.0. MethodsMPX V1.0 or MPX V2.0 reagent was used for NAT screening according to 9 418 ELISA-negative donors(HBsAg-,anti-HCV-, anti-HIV- and TP-). NAT positive samples were confirmed with electrochemical luminescence detection. Results8 samples were positive in 9 418 donors, in which 6 samples were observed MPX V1.0 positive and 6 , MPX V2.0 positive. We found one sample with low CT（MPX V1.0 CT=16.4,MPX V2.0 CT=18）and positive HCV-Ag (MPX V2.0). We believed that this donor was in the window phase of HCV infection confirmed by the second test one month later. ConclusionEither MPX V1.0 or MPX V2.0 reagent may miss low viral load samples (<20IU/mL). The sensitivity needs to be improved. MPX V2.0 can directly distinguish the type of viral infection based on fluorescence. MPX V2.0 is advantageous over MPX V1.0 to explain the positive donors and make early diagnosis.

Key words: Blood, Security, Nucleic, acid, technology, Blood, screening, MPX, V2.0

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