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Background: We previously reported on serum N-glycans as markers for the diagnosis of cirrhosis in patients with chronic hepatitis C infection. Our present study aimed to evaluate the use of serum glycan markers for the diagnosis of liver fibrosis in patients with chronic hepatitis B infection., Methods: Patients with hepatitis B virus (HBV) infection (n=173) were diagnosed by clinical laboratory analysis and histological examination. Liver fibrosis was staged using Ishak score. N-glycan profiles of serum proteins were determined by DNA sequencer-based carbohydrate analytical profiling., Results: We found that in HBV patients, like in hepatitis C virus patients, several serum N-glycans were altered during the development of liver fibrosis. We found higher levels of total agalactosylated biantennary glycans in fibrosis patients with HBV infection than in healthy controls. The biantennary (NA2) and the triantennary (NA3) N-glycans decreased significantly (P<0.001) with increased severity of fibrosis. The diagnostic power of serum glycan marker (GlycoFibroTest) [area under the curve (AUC)=0.735) was similar to that of FibroTest (AUC=0.740) for discriminating between moderate and advanced fibrosis (F3-F6) from non- or mild fibrosis (F0-F2). However, GlycoFibroTest (AUC=0.740) was slightly better than FibroTest (AUC=0.696) for distinguishing fibrotic patients (F1 or more) from non-fibrotic patients (F0)., Conclusions: The assay for serum glycan profiling showed satisfactory reproducibility and is a non-invasive blood test for the diagnosis of liver fibrosis. The changes of N-glycan level in serum can be used to monitor or follow-up the progress of fibrosis using specific N-glycan markers.

Objective: To confirm the diagnostic value of FibroTest-ActiTest (FT-AT) in predicting liver fibrosis and inflammatory activity in patients with chronic hepatitis B (CHB), and to study the discordances between FT and their liver biopsies., Methods: A study was performed on 100 patients with CHB who underwent liver biopsies in our hospital. Serum samples for biochemical markers were taken on the day of their biopsies. Diagnostic accuracies were assessed by ROC curve analysis., Results: The median biopsy specimen size was 15 mm (range: 8-30), with 9 (median) portal tracts (range 5-26). Thirty-nine patients were classified as Ishak F3-F6 in fibrosis and 65 patients as A2-A4 in inflammation. Areas under ROC curve for diagnosis of significant inflammation (A2-A4), significant fibrosis (F3-F6), and cirrhosis (F5-F6) were 0.833 (95% CI: 0.753-0.913), 0.840 (0.750-0.929), and 0.862 (0.721-1.003), respectively. FT less than 0.31 had a NPV of 86% for excluding significant fibrosis, whereas FT > or = 0.72 had a PPV of 92% for predicting significant fibrosis. Among the 26 patients with 2 fibrosis stages of discordances between FT and biopsy, the discordance was attributable to biopsy in 3 cases, to FT in 7, and undetermined in 16., Conclusion: This study confirms the diagnostic value of FT-AT and suggests that 68% of our patients with CHB can be reliably identified by FT without a liver biopsy and with a diagnosis accuracy of 87%.