Clinical efficacy of a novel, high-sensitivity HBcrAg assay in the management of chronic hepatitis B and HBV reactivation
Clinical efficacy of a novel, high-sensitivity HBcrAg assay in the management of chronic hepatitis B and HBV reactivation
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DOI：
10.1016/j.jhep.2021.02.017
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发表时间：
2021-07-16
影响因子：
25.7
通讯作者：
Tanaka, Yasuhito
中科院分区：
文献类型：
--
作者：
Inoue, Takako;Kusumoto, Shigeru;Tanaka, Yasuhito
背景与目的：一种全自动、高灵敏度的新型B型肝炎核心相关抗原检测试剂盒（iTACT-HBcrAg）已经开发出来。我们证明了iTACT-HBcrAg的临床效用监测慢性B肝炎（CHB）和早期检测HBV reactivation.Methods：基本评估后，iTACT-HBcrAg的临床表现与其他HBV标志物进行了比较。i）通过iTACT-HBcrAg和常规HBcrAg测定（G-HBcrAg）测量从161名患有CHB且持续检测不到HBV DNA的HBeAg阴性患者获得的系列血清。ii）通过iTACT-HBcrAg和超高灵敏度HBsAg免疫复合物转移-荧光酶免疫测定法（检测下限; 0.0005 IU/ml，ICT-CLEIA）测量来自13名HBV再激活患者的系列血清，以比较HBV DNA检测。iii）为了阐明iTACT-HBcrAg检测的各种HBcrAg组分，对HBV再激活前后的血清进行OptiPrep密度梯度离心分析。iTACT-HBcrAg的灵敏度（2.1 Log U/ml）约为G-HBcrAg（2.8 Log U/ ml）的10倍。i）97.5%（157/161）的CHB患者血清中HBcrAg可被iTACT-HBcrAg检测到，其中75.2%（121/161）的HBcrAg>-2.8Log U/ml，22.4%（36/161）的HBcrAg为2.1- 2.8Log U/ ml，这是G-HBcrAg检测不到的。（2）13例HBV再激活患者中，在HBV DNA阳性前和HBV DNA阳性时分别有9例和2例iTACTHBcrAg阳性，在ICT-CLEIA阳性前和ICT-CLEIA阳性时分别有7例和4例iTACT-HBcrAg阳性。结论：iTACT-HBcrAg可用于HBeAg阴性患者抗HBV治疗应答的监测和HBV再激活的早期检测。iTACT-HBcrAg可用于监测HBeAg阴性的慢性B型肝炎患者，以及早期发现HBV再激活。iTACT-HBcrAg可用作疾病进展和治疗应答的一般标志物。(C)2021年欧洲肝脏研究协会。Elsevier B. V.出版，保留所有权利。
Background & Aims: A fully automated, novel high-sensitivity hepatitis B core-related antigen assay (iTACT-HBcrAg) has been developed. We demonstrate the clinical utility of iTACT-HBcrAg for monitoring chronic hepatitis B (CHB) and for the early detection of HBV reactivation.Methods: After fundamental assessments, the clinical performance of iTACT-HBcrAg was compared with other HBV markers. i) Serial sera, available from 161 HBeAg-negative patients with CHB and persistently undetectable HBV DNA, were measured by iTACT-HBcrAg and a conventional HBcrAg assay (G-HBcrAg). ii) Serial sera from 13 HBV-reactivated patients were measured by iTACT-HBcrAg and an ultra-high-sensitivity HBsAg immune complex transfer-chemiluminescent enzyme immunoassay (lower limit of detection; 0.0005 IU/ml, ICT-CLEIA) to compare HBV DNA detection. iii) To elucidate the various HBcrAg components detected by iTACT-HBcrAg, OptiPrep density gradient centrifugation analysis was performed on sera obtained before and after HBV reactivation.Results: The analytical performance of iTACT-HBcrAg was satisfactory. The sensitivity of iTACT-HBcrAg (2.1 Log U/ml) was approximately 10-fold greater than that of G-HBcrAg (2.8 Log U/ ml). i) HBcrAg was detectable in the sera of 97.5% (157/161) of patients with CHB by iTACT-HBcrAg, of whom 75.2% (121/161) had >-2.8 Log U/ml HBcrAg and 22.4% (36/161) had 2.1-2.8 Log U/ ml HBcrAg, which was undetectable by G-HBcrAg. ii) 9 and 2 of 13 HBV-reactivated patients were HBcrAg-positive by iTACTHBcrAg before and at HBV DNA positivity, respectively; 7 and 4 were HBcrAg-positive by iTACT-HBcrAg before and at HBsAgpositivity by ICT-CLEIA, respectively. iii) The HBcrAg detected by iTACT-HBcrAg before HBV reactivation was contained in empty particles (22 KDa precore protein).Conclusions: iTACT-HBcrAg could be used to better monitor responses to anti-HBV treatments in HBeAg-negative patients and for the early detection of HBV reactivation.Lay summary: A fully automated, novel high-sensitivity hepatitis B core-related antigen assay (iTACT-HBcrAg) has been developed. iTACT-HBcrAg can be used to monitor HBeAgnegative patients with chronic hepatitis B, as well as for the early detection of HBV reactivation. iTACT-HBcrAg could be used as a general marker of disease progression and treatment response. (C) 2021 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.