Diagnostic accuracy of enhanced liver fibrosis test for nonalcoholic steatohepatitis-related fibrosis: Multicenter study

Yuya Seko; Hirokazu Takahashi; Hidenori Toyoda; Hideki Hayashi; Kanji Yamaguchi; Michihiro Iwaki; Masato Yoneda; Taeang Arai; Toshihide Shima; Hideki Fujii; Asahiro Morishita; Kazuhito Kawata; Kengo Tomita; Miwa Kawanaka; Yuichi Yoshida; Tadashi Ikegami; Kazuo Notsumata; Satoshi Oeda; Yoshihiro Kamada; Yoshio Sumida; Hideaki Fukushima; Eiji Miyoshi; Shinichi Aishima; Takeshi Okanoue; Atsushi Nakajima; Yoshito Itoh; Japan Study Group of Nonalcoholic Fatty Liver Disease (JSG-NAFLD)

doi:10.1111/hepr.13871

Diagnostic accuracy of enhanced liver fibrosis test for nonalcoholic steatohepatitis-related fibrosis: Multicenter study

Hepatol Res. 2023 Apr;53(4):312-321. doi: 10.1111/hepr.13871. Epub 2023 Jan 10.

Authors

Yuya Seko¹, Hirokazu Takahashi², Hidenori Toyoda³, Hideki Hayashi⁴, Kanji Yamaguchi¹, Michihiro Iwaki⁵, Masato Yoneda⁵, Taeang Arai⁶, Toshihide Shima⁷, Hideki Fujii⁸, Asahiro Morishita⁹, Kazuhito Kawata¹⁰, Kengo Tomita¹¹, Miwa Kawanaka¹², Yuichi Yoshida¹³, Tadashi Ikegami¹⁴, Kazuo Notsumata¹⁵, Satoshi Oeda², Yoshihiro Kamada¹⁶, Yoshio Sumida¹⁷, Hideaki Fukushima¹⁸, Eiji Miyoshi¹⁹, Shinichi Aishima²⁰, Takeshi Okanoue⁷, Atsushi Nakajima⁵, Yoshito Itoh¹; Japan Study Group of Nonalcoholic Fatty Liver Disease (JSG-NAFLD)

Affiliations

¹ Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
² Liver Center, Saga University Hospital, Saga, Japan.
³ Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan.
⁴ Department of Gastroenterology and Hepatology, Gifu Municipal Hospital, Gifu, Japan.
⁵ Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
⁶ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan.
⁷ Department of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Suita, Japan.
⁸ Department of Hepatology, Osaka Metropolitan University, Osaka, Japan.
⁹ Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Takamatsu, Japan.
¹⁰ Hepatology Division, Department of Internal Medicine II, Hamamatsu University School of Medicine, Hamamatsu, Japan.
¹¹ Department of Internal Medicine, National Defense Medical College, Tokorozawa, Japan.
¹² General Internal Medicine 2, General Medical Center, Kawasaki Medical School, Okayama, Japan.
¹³ Department of Gastroenterology and Hepatology, Suita Municipal Hospital, Osaka, Japan.
¹⁴ Department of Gastroenterology and Hepatology, Tokyo Medical University Ibaraki Medical Center, Ibaraki, Japan.
¹⁵ Department of General Internal Medicine, Fukui-ken Saiseikai Hospital, Fukui, Japan.
¹⁶ Department of Advanced Metabolic Hepatology, Osaka University Graduate School of Medicine, Suita, Japan.
¹⁷ Division of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University, Nagakute, Japan.
¹⁸ Diagnostics Business Area, Siemens Healthcare Diagnostics K.K., Tokyo, Japan.
¹⁹ Department of Molecular Biochemistry and Clinical Investigation, Osaka University Graduate School of Medicine, Suita, Japan.
²⁰ Department of Pathology and Microbiology, Faculty of Medicine, Saga University, Saga, Japan.

PMID: 36524984
DOI: 10.1111/hepr.13871

Abstract

Aim: The enhanced liver fibrosis (ELF) test is a noninvasive method for diagnosing hepatic fibrosis in patients with nonalcoholic fatty liver disease (NAFLD). This multicenter cohort study aimed to evaluate the accuracy of the ELF test and compare it with other noninvasive tests in Japan.

Methods: We analyzed 371 Japanese patients with biopsy-proven NAFLD. We constructed area under the receiver operator characteristic curves (AUROC) to determine the diagnostic accuracies of the ELF test, the Mac-2-binding protein glycosylation isomer (M2BPGi), the Fibrosis-4 (FIB-4) index, and combinations of these indices.

Results: In patients with F0/F1/F2/F3/F4 fibrosis, the median values of the ELF test were 8.98/9.56/10.39/10.92/11.41, respectively. The AUROCs of the ELF test for patients with F0 versus F1-4, F0-1 versus F2-4, F0-2 versus F3-4, and F0-3 versus F4 fibrosis were 0.825/0.817/0.802/0.812, respectively. The AUROCs of the ELF test were greater than those of the FIB-4 index and M2BPGi at each fibrosis stage. Respective low and high cut-off values yielded sensitivities and specificities for predicting advanced fibrosis (≥F3) of 91.1% and 50.8%, and 38.5% and 92.8%, respectively. For F3 or F4 fibrosis, the combined values from the ELF test and FIB-4 index showed a sensitivity of 98.5%, and the combined values from the ELF test and M2BPGi assay showed a specificity of 97.5%.

Conclusions: In Japan, the ELF test predicts NAFLD-related fibrosis from its early stages. The diagnostic ability of the ELF test was not inferior to that of other indices, and the combined values of ELF plus other indices were more accurate.

Keywords: AUROC; ELF test; FIB-4; M2BPGi; advanced fibrosis; liver fibrosis; nonalcoholic fatty liver disease.