Article

Original Article

Ann Lab Med 2022; 42(2): 249-257

Published online March 1, 2022 https://doi.org/10.3343/alm.2022.42.2.249

Copyright © Korean Society for Laboratory Medicine.

Comparison of Non-Invasive Clinical Algorithms for Liver Fibrosis in Patients With Chronic Hepatitis B to Reduce the Need for Liver Biopsy: Application of Enhanced Liver Fibrosis and Mac-2 Binding Protein Glycosylation Isomer

Mina Hur, M.D., Ph.D.1 , Mikyoung Park, M.D., Ph.D.2 , Hee-Won Moon, M.D., Ph.D.1 , Won Hyeok Choe, M.D., Ph.D.3 , and Chae Hoon Lee, M.D., Ph.D.2

1Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea; 2Department of Laboratory Medicine, Yeungnam University College of Medicine, Daegu, Korea; 3Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea

Correspondence to: Mikyoung Park, M.D., Ph.D.
Department of Laboratory Medicine, Yeungnam University College of Medicine, Yeungnam University Medical Center, 170 Hyunchoong-ro, Nam-gu, Daegu 42415, Korea
Tel: +82-53-640-6703
Fax: +82-53-627-1093
E-mail: mikyoung.pak@gmail.com

Received: June 2, 2021; Revised: August 20, 2021; Accepted: September 10, 2021

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: Non-invasive clinical algorithms for the detection of liver fibrosis (LF) can reduce the need for liver biopsy (LB). We explored the implementation of two serum biomarkers, enhanced liver fibrosis (ELF) and Mac-2 binding protein glycosylation isomer (M2BPGi), in clinical algorithms for LF in chronic hepatitis B (CHB) patients.
Methods: Two clinical algorithms were applied to 152 CHB patients: (1) transient elastography (TE) followed by biomarkers (TE/ELF and TE/M2GPGi); (2) biomarker test followed by TE (ELF/TE and M2BPGi/TE). Using the cut-off value or index for the detection of advanced LF (TE≥F3; 9.8 in ELF and 3.0 in M2BPGi), LB was expected to be performed in cases with discordant TE and biomarker results.
Results: In both algorithms, the expected number of LBs was lower when using M2BPGi than when using ELF (TE/ELF or ELF/TE, 13.2% [N=20]; TE/M2BPGi or M2BPGi/TE, 9.9% [N=15]), although there was no statistical difference (P=0.398). In the TE low-risk group (TE≤F2), the discordance rate was significantly lower in the TE/M2BPGi approach than in the TE/ELF approach (1.5% [2/136] vs. 11.0% [15/136], P=0.002). In the biomarker low-risk group, there was no significant difference between the ELF/TE and M2BPGi/TE approaches (3.9% [5/126] vs. 8.8% [13/147], P=0.118).
Conclusions: Both ELF and M2BPGi can be implemented in non-invasive clinical algorithms for assessing LF in CHB patients. Given the lowest possibility of losing advanced LF cases in the low-risk group when using the TE/M2BPGi approach, this combination seems useful in clinical practice.

Keywords: Enhanced liver fibrosis, Mac-2 binding protein glycosylation isomer, Clinical algorithm, Liver fibrosis, Chronic hepatitis B