Abstract
The fibrosis-4 (FIB-4) index is the most widely used estimated formula to screen for advanced hepatic fibrosis; however, it has a considerable intermediate zone. Here, we propose an algorithm to reduce the intermediate zone and improve the diagnostic performance of screening for advanced liver fibrosis by incorporating Mac-2-binding protein glycan isomer (M2BPGi) into a FIB-4 based screening strategy in an average risk group. Four-hundred eighty-eight healthy and chronic liver disease subjects were analyzed using a 1:1 propensity score matched for age and sex. Advanced liver fibrosis (≥F3) was defined by magnetic resonance elastography (MRE, ≥3.6 kPa). Classification tree analysis was employed to improve diagnostic performance using a combination of the FIB-4 index and M2BPGi. The median serum M2BPGi levels of healthy subjects, patients without advanced fibrosis, and those with the condition were 0.48, 0.94, and 2.93, respectively. The area under the receiver operating characteristic (AUROC) curve of M2BPGi (0.918) for advanced fibrosis was the highest compared to those of the FIB-4 index (0.887), APRI (0.873), and AST/ALT ratio (0.794). When M2BPGi was incorporated following the FIB-4 index, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 87.1%, 82.5%, 54.0%, and 96.4%, respectively. Moreover, 74.3% (133/179) of cases in the intermediate zone of the FIB-4 index avoided unnecessary referrals. Two-step pathway (FIB-4 followed by M2BPGi) could reduce unnecessary referrals and/or liver biopsies in an average-risk population.
Highlights
The early detection of advanced fibrosis in the general population is crucial in clinical practice [1]
This study showed that the Mac-2-binding protein glycan isomer (M2BPGi) level correlates with the degree of hepatic fibrosis
When M2BPGi was incorporated into the FIB-4 index, unnecessary biopsies or referrals were avoided in 74.3% of cases in the intermediate zone of FIB-4
Summary
The early detection of advanced fibrosis in the general population is crucial in clinical practice [1]. Several non-invasive surrogate markers or estimated formulae to screen high-risk groups for advanced hepatic fibrosis have been proposed [2,3]. Among these methods, the non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS) and the FIB-4 index appear to offer the best diagnostic performance for detecting advanced fibrosis [4]. The diagnostic performance (AUROC values) using NFS and FIB-4 was 0.8–0.86 [5] Both the NFS and FIB-4 scores have considerable intermediate zones (~30%), even though both estimated formulae showed good negative predictive performance [6,7]. Because of the considerable intermediate zone and low positive predictive value of the FIB-4 system, several sequential algorithms based on the FIB-4 system have been suggested [8,9]
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