| Abstract: | OBJECTIVE: The EASL has recently proposed an algorithm for the diagnosis of advanced liver fibrosis. We aimed to evaluate the diagnostic accuracy of this algorithm in non-alcoholic fatty liver disease (NAFLD). METHODS: 1,051 patients with NAFLD, liver biopsy and four non-invasive tests (NITs: FIB4, VCTE, FibroMeter, Fibrotest) were included. The ELF score was available in 396 patients. A cohort of 230 patients from primary care/diabetes clinics had FIB4, VCTE and ELF. RESULTS: Compared to the performance of single NITs, agreement between two NITs (FIB4 and VCTE, VCTE and patented serum tests) increased specificity and positive predictive value by 20%, thus justifying the sequential use proposed in the EASL algorithm. The FIB4/VCTE/FibroMeter and FIB4/VCTE/Fibrotest algorithms performed similarly, providing 85% diagnostic accuracy and a liver biopsy requirement rate of only 10%. The FIB4/VCTE/ELF algorithm performed similarly in the subgroup where ELF was available. Simulations of algorithm accuracies at different prevalence showed that positive predictive values rapidly increased, reaching a plateau above 75% starting at 15% prevalence. Negative predictive values remained higher than 90% up to 25% prevalence. The rate of liver biopsy requirement remained stable, increasing by only 5% between low and high prevalence settings. When the EASL algorithm was applied in the primary care/diabetes clinic cohort, liver biopsy requirement was only 3% and the agreement between the three steps provided 75% positive predictive value. CONCLUSION: Our study validates the algorithm proposed by the EASL in its latest 2021 guidelines for the diagnosis of advanced fibrosis in the setting of NAFLD. |
