Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease

TLDR

Liver biopsy remains the gold standard for evaluating histologic lesions in non‑alcoholic fatty liver disease. The study aimed to assess the diagnostic accuracy of FibroTest, a non‑invasive fibrosis marker validated in other liver diseases, in NAFLD patients. A prospective cohort of 267 NAFLD patients (170 single‑center, 97 multicenter) and 954 blood donor controls underwent liver biopsy scored on a five‑stage Kleiner scale, with FibroTest results and histology evaluated blindly and diagnostic performance metrics (AUROC, sensitivity, specificity, PPV, NPV) calculated. FibroTest achieved AUROCs of 0.86 (F2–F4) and 0.92 (F3–F4) in the reference cohort, with similar performance in the multicenter cohort, and a pooled cutoff of 0.30 yielded a 90 % NPV (77 % sensitivity) while a cutoff of 0.70 produced a 73 % PPV (98 % specificity) for advanced fibrosis, confirming its reliability in NAFLD.

Abstract

Abstract Background Liver biopsy is considered as the gold standard for assessing non-alcoholic fatty liver disease (NAFLD) histologic lesions. The aim of this study was to determine the diagnostic utility of non-invasive markers of fibrosis, validated in chronic viral hepatitis and alcoholic liver disease (FibroTest, FT), in patients with NAFLD. Methods 170 patients with suspected NAFLD were prospectively included in a reference center (Group 1), 97 in a multicenter study (Group 2) and 954 blood donors as controls. Fibrosis was assessed on a 5 stage histological scale validated by Kleiner et al from F0 = none, F1 = perisinusoidal or periportal, F2 = perisinusoidal and portal/periportal, F3 = bridging and F4 = cirrhosis. Histology and the biochemical measurements were blinded to any other characteristics. The area under the ROC curves (AUROC), sensitivity (Se), specificity (Sp), positive and negative predictive values (PPV, NPV) were assessed. Results In both groups FT has elevated and not different AUROCs for the diagnosis of advanced fibrosis (F2F3F4): 0.86 (95%CI 0.77–0.91) versus 0.75 (95%CI 0.61–0.83; P = 0.10), and for F3F4: 0.92 (95%CI 0.83–0.96) versus 0.81 (95%CI 0.64–0.91; P = 0.12) in Group1 and Group 2 respectively. When the 2 groups were pooled together a FT cutoff of 0.30 had a 90% NPV for advanced fibrosis (Se 77%); a FT cutoff of 0.70 had a 73% PPV for advanced fibrosis (Sp 98%). Conclusion In patients with NAFLD, FibroTest, a simple and non-invasive quantitative estimate of liver fibrosis reliably predicts advanced fibrosis.