Four independent centers provided four blood tests and Metavir staging from 825 patients with chronic hepatitis C.
FibroMeter AUROC (0.840) for significant fibrosis was superior to those of Fibrotest (0.803, p = 0.049), APRI (0.789, p = 0.001) and Hepascore (0.781, p < 0.001). The misclassification rate was lower for FibroMeter (23 % ) than for Fibrotest and Hepascore (both 28 % , p < 0.001). The variation in the diagnostic cut-offs of tests among centers, reflecting the overall reproducibility, was: FibroMeter: 4.2 % , APRI: 24.0 % , Fibrotest: 24.2 % , Hepascore: 35.0 % . Accordingly, the proportion of patients diagnosed with significant fibrosis changed: FibroMeter: 0.8 % , Hepascore: 2.4 % (p = 0.02 vs FibroMeter), Fibrotest: 5.8 % (p < 10− 3), APRI: 18.2 % (p < 10− 3).
This study on clinical applicability shows significant differences in diagnostic accuracy, inter-center reproducibility, and robustness of biomarkers to changes in population characteristics between blood tests.