乙型肝炎表面抗原血清清除后有或没有发展为肝细胞癌的患

StephenW

Potential of ultra-highly sensitive immunoassays for hepatitis B surface and core-related antigens in patients with or without development of hepatocellular carcinoma after hepatitis B surface antigen seroclearance
Fumitaka Suzuki  1 , Tetsuya Hosaka  1 , Masayasu Imaizumi  2 , Mariko Kobayashi  3 , Chiharu Ohue  4 , Yoshiyuki Suzuki  1 , Shunichiro Fujiyama  1 , Yusuke Kawamura  1 , Hitomi Sezaki  1 , Norio Akuta  1 , Masahiro Kobayashi  1 , Satoshi Saitoh  1 , Yasuji Arase  1 , Kenji Ikeda  1 , Hiromitsu Kumada  1
Affiliations
Affiliations

    1
    Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
    2
    Product Development Department, Fujirebio Inc, Hachioji, Tokyo, Japan.
    3
    Research Institute for Hepatology, Toranomon Hospital, Tokyo, Japan.
    4
    Research and Development Department, Advanced Life Science Institute, Inc., Hachioji, Tokyo, Japan.

    PMID: 33270344 DOI: 10.1111/hepr.13602

Abstract

Aims: Hepatitis B surface antigen (HBsAg) seroclearance indicates a "functional cure" in chronic hepatitis B virus (HBV) infection (CHB). However, several cases of hepatocellular carcinoma (HCC) development have been reported after HBsAg seroclearance. We evaluated the potential of HBsAg and hepatitis B core-related antigen (HBcrAg), measured by the ultra-highly sensitive assays, in cases with HCC development after HBsAg seroclearance.

Methods: We enrolled 17 patients with CHB who achieved HBsAg seroclearance, defined by the conventional assay using Architect HBsAg QT kit (5 HCC patients and 12 non-HCC patients). HBsAg and HBcrAg were measured in their stored serum samples using ultra-highly sensitive assays featuring "immunoassay for total antigen including complex via pretreatment (iTACT)" technology.

Results: All 5 patients who developed HCC were positive for HBsAg or HBcrAg by iTACT-HBsAg or iTACT-HBcrAg at all follow-up points. HBcrAg levels in the HCC group, using iTACT-HBcrAg, were significantly higher than those in the non-HCC group at HBsAg seroclearance (3.6 LogU/mL (2.8-4.2) vs. 2.6 (<2.1-3.8), p=0.020). The best cutoff value of iTACT-HBcrAg for predicting HCC development was 2.7 LogU/mL by receiver operating characteristic curve analysis. The prevalence of HBcrAg ≥2.7 in the HCC group was significantly higher than that in non-HCC group (100% (5/5) vs. 33% (4/12), p=0.029).

Conclusions: Residual low viral antigen might predict HCC development even if HBsAg seroclearance was achieved according to a conventional assay. The results suggest that iTACT assays of HBsAg and HBcrAg would be useful for monitoring CHB patients. (239 words).

Keywords: Hepatitis B core-related antigen; Hepatitis B surface antigen; Hepatocellular carcinoma; Immunoassay; iTACT (immunoassay for total antigen including complex via pre-treatment).

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StephenW

乙型肝炎表面抗原血清清除后有或没有发展为肝细胞癌的患者的超高灵敏度免疫分析对乙型肝炎表面和核心相关抗原的潜力
铃木富孝1，保坂哲也1，今泉雅之2，小林真理子3，大上千春4，铃木嘉之1，藤山俊一郎1，川村雄介1，濑户瞳1，赤田纪夫1，小林正博1，斋藤聪1，靖三1，池田贤治1，熊田裕光1
隶属关系
隶属关系

    1个
    日本东京虎之门医院肝病科。
    2
    日本东京八王子市Fujirebio Inc产品开发部。
    3
    日本东京虎之门医院肝病研究所。
    4
    日本东京八王子市高级生命科学研究所公司研发部。

    PMID：33270344 DOI：10.1111 / hepr.13602

抽象

目的：乙型肝炎表面抗原（HBsAg）的血清清除表明慢性乙型肝炎病毒（HBV）感染（CHB）的“功能性治愈”。但是，已经报道了HBsAg血清清除后发生的几例肝细胞癌（HCC）病例。我们评估了通过超高灵敏度测定法测量的HBsAg和乙型肝炎核心相关抗原（HBcrAg）在HBsAg血清清除后发生HCC的情况下的潜力。

方法：我们招募了17名CHB患者，这些患者通过使用Architect HBsAg QT试剂盒进行的常规检测定义为HBsAg血清清除（5例HCC患者和12例非HCC患者）。 HBsAg和HBcrAg使用超高灵敏测定法在“储存的血清样品中进行测定”，该测定法采用“通过预处理（iTACT）对包括复合物在内的总抗原进行免疫测定”技术。

结果：所有iTACT-HBsAg或iTACT-HBcrAg的所有5例肝癌患者的HBsAg或HBcrAg阳性。使用iTACT-HBcrAg的HCC组中HBcrAg水平在HBsAg血清清除率上显着高于非HCC组（3.6 LogU / mL（2.8-4.2）对2.6（<2.1-3.8），p = 0.020） 。通过接受者工作特征曲线分析，预测肝癌发展的iTACT-HBcrAg的最佳临界值为2.7 LogU / mL。 HCC组中HBcrAg≥2.7的患病率显着高于非HCC组（100％（5/5）对33％（4/12），p = 0.029）。

结论：残留的低病毒抗原即使根据常规检测方法已达到HBsAg血清清除率，仍可预测HCC的发生。结果表明，HBsAg和HBcrAg的iTACT检测可用于监测CHB患者。 （239个字）。

关键词：乙型肝炎核心相关抗原乙型肝炎表面抗原；肝细胞癌；免疫测定iTACT（通过预处理对包括复合物在内的总抗原进行免疫测定）。

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