期刊
JOURNAL OF HEPATOLOGY
卷 75, 期 2, 页码 302-310出版社
ELSEVIER
DOI: 10.1016/j.jhep.2021.02.017
关键词
hepatitis B virus; high-sensitivity hepatitis B core-related antigen assay; HBcrAg; chronic hepatitis B; reactivation
资金
- Japan Agency for Medical Research and Development [AMED JP19fk0310101, JP20fk0310101]
- Ministry of Education, Culture, Sports, Science and Technology [19H03640]
- Grants-in-Aid for Scientific Research [19H03640] Funding Source: KAKEN
A fully automated, novel high-sensitivity hepatitis B core-related antigen assay (iTACT-HBcrAg) has been developed for monitoring chronic hepatitis B (CHB) and for the early detection of HBV reactivation. The clinical performance of iTACT-HBcrAg was compared with other HBV markers, showing satisfactory analytical performance and potential as a general marker of disease progression and treatment response.
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.
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