Fibromax and inflamatory markers cannot replace liver biopsy in the evaluation of non-alcoholic fatty liver disease.

BACKGROUND To evaluate the performance of a non-invasive test (Fibromax™) and inflamatory markers (IL-1 beta, IL-6, IL-8, TNF-alpha, MCP-1) in the diagnosis and staging of patients with non-alcoholic fatty liver disease. METHODS Patients older than 18 years with steatosis were prospectively evaluated at a tertiary hospital in southern Brazil. Liver biopsy, Fibromax™ test and inflamatory markers (IL 1 beta, IL-6, IL-8, TNF-alpha, MCP-1) were performed. Measures of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were used, considering liver biopsy as the gold standard. RESULTS Seventy three Fibromax™ tests were analyzed. Steatotest presented a sensitivity of 95.5% and PPV of 97.0% for the diagnosis of steatosis. Nashtest obtained a sensitivity of 83.3%, specificity of 37.5%, PPV of 90.9% and NPV of 23.1% for the diagnosis of non-alcoholic steatohepatitis (NASH). Fibrotest presented a sensitivity of 38.9%, specificity of 92.7%, PPV of 63.6% and NPV of 82.3% to evaluate advanced fibrosis. In the evaluation of patients with grade 2 and 3 steatosis, ROC analyses showed an area under the curve (AUROC) for Steatotest of 0.68 (p=0.015). Nashtest AUROC was 0.59 (p=0.417) for the evaluation of NASH. Fibrotest AUROC was 0.79 (p<0.001) for advanced fibrosis. Kappa coefficient values for Steatotest, Nashtest and Fibrotest were not statistically significant. Thirty seven patients performed also analysis of the inflamatory markers, showing that patients with inflammatory activity grade 2-3 on liver biopsy had significantly higher levels of IL6 (p=0.016) and lower TNF-alpha (p=0,034), but there was no other difference when analysed fibrosis or steatosis. CONCLUSIONS The Fibromax™ test and the inflamatory markers (IL 1 beta, IL-6, IL-8, TNF-alpha, MCP-1) did not present a satisfactory performance to be considered a good alternative to replace liver biopsy in the evaluation of NAFLD.