Ann Lab Med 2019; 39(1): 67-75  https://doi.org/10.3343/alm.2019.39.1.67
Performance of Hepatitis B Core-Related Antigen Versus Hepatitis B Surface Antigen and Hepatitis B Virus DNA in Predicting HBeAg-positive and HBeAg-negative Chronic Hepatitis
Zhan-qing Zhang, M.D.1*, Yan-bing Wang, M.D.1*, Wei Lu, M.D.1, Dan-ping Liu, M.D.1, Bi-sheng Shi, Ph.D.2, Xiao-nan Zhang, Ph.D.2, Dan Huang, M.D.1, Xiu-fen Li, M.D.1, Xin-lan Zhou, M.D.1, and Rong-rong Ding, M.D.1
1Department of Hepatobiliary Medicine and 2Research Unit, Shanghai Public Health Clinical Center of Fudan University, Shanghai, China
Corresponding author: Zhan-qing Zhang, M.D.
https://orcid.org/0000-0001-7709-9027
Department of Hepatobiliary Medicine, Shanghai Public Health Clinical Center of Fudan University, Caolang Road 2901, Shanghai 201508, China
Tel: +8621-37990333 ext. 3245
E-mail: doctorzzqsphc@163.com
*These authors contributed equally to this work.
Received: December 16, 2017; Revised: April 8, 2018; Accepted: August 20, 2018; Published online: January 1, 2019.
© Korean Society for Laboratory Medicine. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: We examined changes in hepatitis B core-related antigen (HBcrAg) during the four sequential phases of chronic hepatitis B virus (HBV) infection: hepatitis B e antigen (HBeAg)-positive chronic infection (EPCI) and hepatitis (EPCH), followed by HBeAg-negative chronic infection (ENCI) and hepatitis (ENCH). We compared the performance of serum HBcrAg, hepatitis B surface antigen (HBsAg), and HBV DNA in predicting EPCH and ENCH.
Methods: We enrolled 492 consecutive patients: 49 with EPCI, 243 with EPCH, 101 with ENCI, and 99 with ENCH. HBcrAg was detected by chemiluminescent enzyme immunoassays. HBsAg and HBeAg were detected by chemiluminescent microparticle immunoassays. HBV DNA was detected by real-time PCR. Predictive performance of HBcrAg, HBsAg, and HBV DNA was evaluated using ROC curves.
Results: Areas under ROC curves (AUCs) of HBcrAg, HBsAg, and HBV DNA for predicting EPCH were 0.738, 0.812, and 0.717, respectively; optimal cutoffs were ≤1.43×105 kU/mL, ≤1.89×104 IU/mL, and ≤3.97×107 IU/mL, with sensitivities and specificities of 66.3% and 77.6%, 65.0% and 93.9%, and 60.5% and 79.6%, respectively. AUCs of HBcrAg, HBsAg, and HBV DNA for predicting ENCH were 0.887, 0.581, and 0.978, respectively; optimal cutoffs were >26.8 kU/mL, >2.29×102 IU/mL, and >8.75×103 IU/mL, with sensitivities and specificities of 72.7% and 95.1%, 86.9% and 39.6%, and 89.9% and 92.1%, respectively.
Conclusions: HBsAg and HBV DNA were the best predictors of EPCH and ENCH, respectively. HBcrAg is an important surrogate marker for predicting EPCH and ENCH.
Keywords: Hepatitis B core-related antigen, Hepatitis B surface antigen, Hepatitis B virus DNA, Chronic hepatitis B, Performance



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