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Background and Aim: There is an immediate need for non‐invasive accurate tests for diagnosing liver fibrosis in patients with non‐alcoholic steatohepatitis (NASH). Previously, it has been suggested that MACK‐3 (a formula that combines homeostasis model assessment‐insulin resistance with serum serum aspartate aminotransferase and cytokeratin [CK]18‐M30 levels) accurately identifies patients with fibrotic NASH. Our aim was to assess the performance of MACK‐3 and develop a novel, non‐invasive algorithm for diagnosing fibrotic NASH. Methods: Six hundred and thirty‐six adults with biopsy‐proven non‐alcoholic fatty liver disease (NAFLD) from two independent Asian cohorts were enrolled in our study. Liver stiffness measurement (LSM) was assessed by vibration‐controlled transient elastography (Fibroscan). Fibrotic NASH was defined as NASH with a NAFLD activity score (NAS) ≥ 4 and F ≥ 2 fibrosis. Results: Metabolic syndrome (MetS), platelet count and MACK‐3 were independent predictors of fibrotic NASH. On the basis of their regression coefficients, we developed a novel nomogram showing a good discriminatory ability (area under receiver operating characteristic curve [AUROC]: 0.79, 95% confidence interval [CI 0.75–0.83]) and a high negative predictive value (NPV: 94.7%) to rule out fibrotic NASH. In the validation set, this nomogram had a higher AUROC (0.81, 95%CI 0.74–0.87) than that of MACK‐3 (AUROC: 0.75, 95%CI 0.68–0.82; P < 0.05) with a NPV of 93.2%. The sequential combination of this nomogram with LSM data avoided the need for liver biopsy in 56.9% of patients. Conclusions: Our novel nomogram (combining MACK‐3, platelet count and MetS) shows promising utility for diagnosing fibrotic NASH. The sequential combination of this nomogram and vibration‐controlled transient elastography limits indeterminate results and reduces the number of unnecessary liver biopsies. [ABSTRACT FROM AUTHOR]

Background and Aim: Patatin‐like phospholipase domain‐containing protein 3 (PNPLA3) I148M (rs738409) genotype influences clinical/biochemical characteristics in patients with nonalcoholic fatty liver disease (NAFLD), but whether PNPLA3‐I148M (rs738409) genotype also influences the diagnostic performance of noninvasive diagnostic tests for NAFLD is uncertain. Our aim was to investigate the differences in diagnostic performance of noninvasive diagnostic tests for NAFLD according to PNPLA3‐I148M (rs738409) genotype. Methods: Fifty‐eight healthy controls and 349 patients with biopsy‐proven NAFLD were included. Areas under the receiver operating characteristic curve (AUROCs) were calculated to predict hepatic steatosis (fatty liver index and hepatic steatosis index), nonalcoholic steatohepatitis (cytokeratin‐18 M30 and M65), and significant fibrosis (≥F2 fibrosis) (fibrosis‐4 and BARD), stratifying by rs738409 genotypes (CC and CG + GG groups). Results: Fatty liver index and hepatic steatosis index showed good diagnostic performance for diagnosing steatosis only in the CG + GG group with AUROCs ranging from 0.819 to 0.832. Cytokeratin‐18 M30 (AUROC = 0.688) and M65 (AUROC = 0.678) had suboptimal performance for diagnosing nonalcoholic steatohepatitis in the CG + GG group, whereas both had good performance (AUROC = 0.814 and 0.813, respectively) in the CC group. BARD score showed good performance in the CG + GG group compared with the CC group (AUROC = 0.805 and 0.532, respectively). Fibrosis‐4 had suboptimal performance in the CG + GG group and good performance in the CC group (AUROC = 0.662 and 0.801, respectively). Conclusions: Diagnostic performance of noninvasive tests for NAFLD varied markedly according to PNPLA3 genotypes. Clinicians should be aware that PNPLA3 genotype limits the clinical utility of noninvasive diagnostic tests for diagnosing NAFLD. [ABSTRACT FROM AUTHOR]