S2417 Diagnostic Accuracy of Non-Invasive Biomarkers in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis: A Systematic Review and Meta-Analysis

Introduction: Metabolic dysfunction-associated steatotic liver disease (MASLD) involves liver fat accumulation in individuals with metabolic risk factors such as diabetes, obesity, high blood pressure, or high cholesterol, and drink little to no alcohol. Approximately 20% develop metabolic dysfunction-associated steatohepatitis (MASH), a more severe form that may progress to cirrhosis or end-stage liver disease. While liver biopsy is the diagnostic gold standard, its invasiveness limits use. Non-invasive biomarkers have emerged as promising alternatives in assessing fibrosis and steatosis severity. This systematic review and meta-analysis evaluates the role of these biomarkers in improving NAFLD/NASH diagnosis. Methods: A comprehensive search of PubMed, Scopus, Cochrane, and Embase was conducted to retrieve observational studies, which included prospective or retrospective cohorts or cross-sectional studies using novel biomarkers as a diagnostic test for MASLD/MASH. Outcomes included sensitivity, specificity, positive and negative likelihood ratios. Analysis was performed in R using a random-effects model. Risk of bias assessment was assessed with ROBINS-I. Results: Eleven studies comprising 5,987 individuals were included. The mean age was 46.2 years, and 55% were man. The studies compared different novel biomarker types like NISA (IV), UAP, LSM, CK-18, OX NASH Score, Fuc-Hpt, M30 antigen, FIB-4, APRI, Age-Platelet Index, aspartate aminotransferase/alanine aminotransferase, Fibrosis Index (FI), Fibrosis Cirrhosis Index (FCI), and MACK-3 to diagnose MASLD or MASH. Our results showed that the overall specificity of those novel biomarkers was 0.81 (95% CI: 0.693–0.890), and the pooled sensitivity was 0.800 (95% CI: 0.714 to 0.865). The results showed the pooled positive likelihood ratio was 4.172 (95% CI: 2.510 to 6.936), and the overall negative likelihood ratio was 0.244 (95% CI: 0.159–0.374). A summary receiver operating characteristic (SROC) curve was also constructed. The curve rises fairly consistently and levels off near the top left corner of the graph, indicating high sensitivity. It also exhibits a reasonable specificity. Conclusion: This meta-analysis demonstrates that non-invasive biomarkers exhibit strong diagnostic accuracy for MASLD/MASH, supported by high sensitivity, specificity, and robust likelihood ratios. The SROC curve further confirms their discriminatory ability. These findings support integrating non-invasive biomarkers into diagnostic algorithms to improve patient stratification and reduce reliance on invasive procedures.