qFibrosis: A fully-quantitative innovative method incorporating histological features to facilitate accurate fibrosis scoring in animal model and chronic hepatitis B patients

Background & Aims There is increasing need for accurate assessment of liver fibrosis/cirrhosis. We aimed to develop q Fibrosis, a fully-automated assessment method combining quantification of histopathological architectural features, to address unmet needs in core biopsy evaluation of fibrosis in chronic hepatitis B (CHB) patients. Methods q Fibrosis was established as a combined index based on 87 parameters of architectural features. Images acquired from 25 Thioacetamide-treated rat samples and 162 CHB core biopsies were used to train and test q Fibrosis and to demonstrate its reproducibility. q Fibrosis scoring was analyzed employing Metavir and Ishak fibrosis staging as standard references, and collagen proportionate area (CPA) measurement for comparison. Results q Fibrosis faithfully and reliably recapitulates Metavir fibrosis scores, as it can identify differences between all stages in both animal samples ( p p 2 ; AUC: 0.84–0.97 for biopsies: 10–44mm in length). q Fibrosis can significantly predict staging underestimation in suboptimal biopsies ( p q Fibrosis can also differentiate between Ishak stages 5 and 6 (AUC: 0.73, p =0.008), suggesting the possibility of monitoring intra-stage cirrhosis changes. Best of all, q Fibrosis demonstrates superior performance to CPA on all counts. Conclusions q Fibrosis can improve fibrosis scoring accuracy and throughput, thus allowing for reproducible and reliable analysis of efficacies of anti-fibrotic therapies in clinical research and practice.