Validation of a two-step approach combining serum biomarkers and liver stiffness measurement to predict advanced fibrosis.

Abstract

BACKGROUND AND AIM:

The Gut and Obesity in Asia Workgroup recently reported that a two-step approach using fibrosis scores followed by liver stiffness measurement (LSM) could accurately detect patients with non-alcoholic fatty liver disease (NAFLD) having advanced fibrosis in low-risk fibrosis populations. This study aimed to validate the utility of this approach using a Japanese health checkup registry.

METHODS:

This cross-sectional study included subjects who underwent a health checkup from 2014 to 2019. Using estimated fibrosis stage measured by LSM as a standard, we calculated the percentage of misclassification from assessments made based on fibrosis scores (NAFLD fibrosis score [NFS] or Fibrosis-4 score [FIB-4]) and LSM, alone or in combination.

RESULTS:

Of 630 subjects with NAFLD, 4 (0.8%) had advanced fibrosis. In the first-step evaluation, only 21.4-38.0% of subjects needed further testing. This approach was associated with a high specificity of approximately 100% and a negative predictive value of 99.7%. The percentage of misclassification based on NFS or FIB-4 values followed by LSM in all subjects and using LSM after NFS or FIB-4 determination only in subjects with indeterminate/high NFS or FIB-4 values (two-step approach) was 0% and 0.3% and 0.16% and 0.3%, respectively. In addition, very few false negatives occurred for both NFS and FIB-4.

CONCLUSION:

The two-step approach helps to identify the subjects with NAFLD who have advanced fibrosis during a routine health checkup and is associated with only a few false negatives.

• Authors: Hideki Fujii, Masaru Enomoto, Shinya Fukumoto, Tatsuo Kimura, Yuji Nadatani, Shingo Takashima, Atsushi Hagihara, Sawako Uchida-Kobayashi, Akihiro Tamori, Naoki Nishimoto, Norifumi Kawada
• Journal: JGH open : an open access journal of gastroenterology and hepatology (JGH Open) Vol. 5 Issue 7 Pg. 801-808 (Jul 2021) ISSN: 2397-9070 [Electronic] Australia
• PMID: 34263075 (Publication Type: Journal Article)
• Copyright: © 2021 The Authors. JGH Open published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.