Clinical evaluation of a novel and highly sensitive immunoassay for anti-hepatitis B core antigen using a fully automated immunochemical analyzer.
Clinical evaluation of a novel and highly sensitive immunoassay for anti-hepatitis B core antigen using a fully automated immunochemical analyzer.
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使用全自动免疫化学分析仪对抗乙型肝炎核心抗原的新型高灵敏度免疫测定进行临床评估。
DOI：
10.1111/hepr.13229
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发表时间：
2018
期刊：
影响因子：
--
通讯作者：
Tanaka Y.
中科院分区：
文献类型：
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作者：
Izumida K;Kaneko A;Takahashi K;Kusumoto S;Narita T;Takami A;Iida S;Aoyagi K;Tanaka Y.
目的近年来，在各种治疗前，建议检测B型肝炎表面抗原和抗B型肝炎核心抗原（HBcAb）和/或抗B型肝炎表面抗原，以识别存在B型肝炎病毒（HBV）再激活风险的患者。然而，最近的一项研究报告，HBV再激活发生在HBcAb阴性患者中，表明使用传统HBcAb试剂识别有HBV感染史的患者具有挑战性。我们开发了一种高灵敏度的HBcAb（HBcAb-HS）检测，以降低HBV再激活的风险。MethodsThe HBcAb-HS检测是一种自动荧光酶免疫分析系统，适用于临床使用。根据HBcAb阴性标本的分布模式，将临界值设定为0.020 IU/mL，并与常规试剂进行比较，评价了该检测试剂盒的性能。结果：该检测试剂盒的灵敏度是常规HBcAb试剂的27-81倍;定量测量范围为0.005 IU/mL至1.500 IU/mL，显示出优异的定量性能，并且与两种常规测定法具有良好的相关性，使用HBcAb阳性标本。此外，它对469份购买的HBcAb阴性标本显示出100%的特异性。值得注意的是，这种新开发的HBcAb-HS检测在HBV再活化前的保存标本中显示阳性，常规HBcAb试剂对此给出阴性结果，并且HBcAb-HS检测即使在强化免疫抑制治疗（包括自体造血干细胞移植）后也可以检测到较低的HBcAb水平。高灵敏度的HBcAb检测将能够更准确地识别有HBV再激活风险的患者。
AimRecently, the measurement of hepatitis B surface antigen and anti‐hepatitis B core antigen (HBcAb) and/or anti‐hepatitis B surface antigen has been recommended before various therapies to identify patients at risk of hepatitis B virus (HBV) reactivation. However, a recent study reported that HBV reactivation occurred in HBcAb‐negative patients, indicating that it is challenging to identify patients with a history of HBV infection using conventional HBcAb reagent. We developed a highly sensitive HBcAb (HBcAb‐HS) assay for reducing the risk of HBV reactivation.MethodsThe HBcAb‐HS assay is an automated chemiluminescent enzyme immunoassay system, which is suitable for clinical use. The cut‐off was set at 0.020 IU/mL from the distribution patterns of HBcAb‐negative specimens, and we evaluated the performance of this assay compared with conventional reagents.ResultsThis new assay showed a 27–81‐fold greater sensitivity than conventional HBcAb reagents; the quantified measurement range was from 0.005 IU/mL to 1.500 IU/mL, and it showed excellent quantitative performance and correlated well with two conventional assays, using the HBcAb‐positive specimens. Moreover, it showed 100% specificity for the 469 purchased HBcAb‐negative specimens. Notably, this newly developed HBcAb‐HS assay showed positivity in the preserved specimens before HBV reactivation, for which conventional HBcAb reagents gave negative results, and the HBcAb‐HS assay could detect the lower HBcAb levels even after intensive immunosuppressive therapies, including autologous hematopoietic stem cell transplantation.ConclusionsThe clinical efficacy of the newly developed, highly sensitive HBcAb assay would enable the identification of patients at risk of HBV reactivation more accurately.