Relative performances of FibroTest, Fibroscan and biopsy for assessing the stage of liver fibrosis in patients with chronic hepatitis C: a step toward the truth in the absence of a gold standard

2012 Journal of Hepatology 56;3 (541-548)

BACKGROUND: Liver fibrosis stage is traditionally assessed with biopsy, an imperfect gold standard. Two widely used techniques, FibroTest(R), and liver stiffness measurement (LSM) using Fibroscan(R) have been validated using biopsy, and therefore the true performances of these estimates are still unknown in the absence of a perfect reference. The aim was to assess the relative accuracy of FibroTest, LSM, and biopsy using methods without gold standard in patients with chronic hepatitis C (CHC) and controls. METHODS: A total of 1289 patients with CHC and 604 healthy volunteers, with assessment of fibrosis stage by the 3 techniques, and alanine aminotranferase (ALT) taken as a control test, were analyzed by latent class method with random effects. In the volunteers, the false positive risk of biopsy was obtained from a large surgical sample of four normal livers. RESULTS: The latent class model with random effects permitted to conciliate the observed data and estimates of tests' performances. For advanced fibrosis the specificity/sensitivity was for FibroTest 0.93/0.70, LSM 0.96/0.45, ALT 0.79/0.78 and biopsy 0.67/0.63, and for cirrhosis FibroTest 0.87/0.41, LSM 0.93/0.39, ALT 0.78/0.08 and biopsy 0.95/0.51. The analysis of the discordances between pairs suggested that the variability of the model was mainly related to the discordances between biopsy and LSM (residuals>10; P