新型和高度灵敏的免疫测定的总乙型肝炎表面抗原，包括与

StephenW

Journal of Gastroenterology

March 2017, Volume 52, Issue 3,                        pp 376–384

Novel and highly sensitive immunoassay for total hepatitis B surface antigen, including that complexed with hepatitis B surface antibody

• Authors
• Authors and affiliations
  
  

• Akihiro Matsumoto
• Masayasu Imaizumi
• Yasuhito Tanaka
• Shuhei Nishiguchi
• Hiroshi Yatsuhashi
• Takehiko Ishida
• Kazushige Moriyama
• Katsumi Aoyagi
• Eiji TanakaEmail author
  

• Akihiro Matsumoto
  
  • 1
    
• Masayasu Imaizumi
  
  • 2
    
• Yasuhito Tanaka
  
  • 3
    
• Shuhei Nishiguchi
  
  • 4
    
• Hiroshi Yatsuhashi
  
  • 5
    
• Takehiko Ishida
  
  • 6
    
• Kazushige Moriyama
  
  • 2
    
• Katsumi Aoyagi
  
  • 2
  • 6
    
• Eiji Tanaka
  
  • 1
    
  Email author

• 1.Department of MedicineShinshu University School of MedicineMatsumotoJapan
• 2.New Product Development DepartmentFujirebio Inc.HachiojiJapan
• 3.Department of Virology and Liver UnitNagoya City University Graduate School of Medical SciencesNagoyaJapan
• 4.Division of Hepatobiliary and Pancreatic Disease, Department of Internal MedicineHyogo College of MedicineNishinomiyaJapan
• 5.Clinical Research CenterNational Hospital Organization, Nagasaki Medical CenterOmuraJapan
• 6.Research and Development DepartmentAdvanced Life Science Institute Inc.WakoJapan
  

Original Article—Liver, Pancreas, and Biliary TractFirst Online: 26 July 2016

DOI:            10.1007/s00535-016-1244-7

Cite this article as: Matsumoto, A., Imaizumi, M., Tanaka, Y. et al. J Gastroenterol (2017) 52: 376. doi:10.1007/s00535-016-1244-7
            

•                          238                         Downloads
  

   


AbstractBackground

Hepatitis B surface antigen (HBsAg) is used as a clinical marker of hepatitis B virus (HBV) infection. However, conventional HBsAg assays have so far failed to accurately detect HBsAg in blood because of interference by patient-derived antibodies against HBsAg (HBsAb).

Methods

We developed a novel, fully automated assay system that can detect total HBsAg in blood, including antigens complexed with HBsAb. The immunoassay inactivates HBsAb via a simple pretreatment step to dissociate the HBsAg molecule from HBsAg–HBsAb complexes and thereby estimate total HBsAg. Accordingly, the test has been termed the “immunoassay for total antigen including complex via pretreatment (iTACT)-HBsAg.”

Results

The recovery rate of HBsAg in the presence of HBsAb was greater than 87 % at a cutoff value set at 5.0 mIU/mL on the basis of data from 545 healthy controls. Analyses using serial serum samples from 25 HBV carriers who became negative for HBsAg during follow-up showed that the iTACT-HBsAg could detect HBsAg over a period of years despite a loss in detection by conventional assays and was able to detect HBsAg in 39 (53 %) of 73 samples with HBsAb.

Conclusions

The new iTACT-HBsAg assay appears to detect total HBsAg with high sensitivity, even in the presence of HBsAb, and may useful in identifying subclinical or occult HBV carriers.

KeywordsImmunoassayHepatitis B surface antigenImmunoassay for total antigen including complex via pretreatment

StephenW

胃肠病学杂志

2017年3月，第52卷，第3期，第376-384页
新型和高度灵敏的免疫测定的总乙型肝炎表面抗原，包括与乙型肝炎表面抗体复合

    作者
    作者和关系

    Akihiro MatsumotoMasayasu ImaizumiYasuhito TanakaShuhei NishiguchiHiroshi YatsuhashiTakehiko IshidaKazushige MoriyamaKatsumi AoyagiEiji TanakaEmail author

    Akihiro Matsumoto
        1
    Masayasu Imaizumi
        2
    田中安
        3
    西内平河
        4
    Yoshashihashi
        5
    石田彦
        6
    Moriyama
        2
    Katsumi Aoyagi
        26
    田中贵子
        1电子邮件作者

    大学院医学部松本大学
    2.新产品开发部Fujirebio Inc.Hachioji日本
    3.病毒学与肝脏单位名古屋市立大学大学院医学科学研究科
    内科医学部肝胆和胰腺疾病分类
    5.临床研究中心国立医院组织，长崎医疗中心日本村
    6.研究开发部高级生命科学研究所

原文 - 肝脏，胰腺和胆道

首先在线：
    2016年7月26日

DOI：10.1007 / s00535-016-1244-7

引用本文：
    Matsumoto，A.，Imaizumi，M.，Tanaka，Y.et al。 J Gastroenterol（2017）52：376。doi：10.1007 / s00535-016-1244-7

    238下载

抽象
背景

乙型肝炎表面抗原（HBsAg）用作乙型肝炎病毒（HBV）感染的临床标志物。然而，由于患者来源的抗体对HBsAg（HBsAb）的干扰，常规的HBsAg测定迄今未能精确检测血液中的HBsAg。
方法

我们开发了一种新的，全自动化测定系统，可以检测血液中的总HBsAg，包括与HBsAb复合的抗原。免疫测定通过简单的预处理步骤使HBsAg失活，以从HBsAg-HBsAb复合物中解离HBsAg分子，从而估计总HBsAg。因此，该试验称为“包括通过预处理的复合物（iTACT）-HBsAg的总抗原的免疫测定”。
结果

基于来自545健康对照的数据，在HBsAb存在下HBsAg的回收率大于87％，截止值设定为5.0mIU / mL。使用来自25个HBV携带者的血清样品进行分析，在随访期间HBsAg阴性，表明iTACT-HBsAg可以在数年的时间内检测到HBsAg，尽管通过常规检测方法的检测损失，并且能够在39（53）中检测到HBsAg ％）的73个样品与HBsAb。
结论

新的iTACT-HBsAg检测似乎检测总HBsAg高灵敏度，即使在HBsAb的存在，并可能有助于识别亚临床或隐匿性HBV携带者。
关键词
免疫测定乙型肝炎表面抗原免疫测定总抗原，包括通过预处理的复合物

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