Diagnostic Accuracy of Serum Hyaluronan for Detecting HCV Infection and Liver Fibrosis in Asymptomatic Blood Donors

Abstract

Background: The disease caused by hepatitis C virus (HCV) is asymptomatic, silent, and progressive liver disease. In HCV-infected patients the increase in serum HA is associated with the development of hepatic fibrosis and disease progression. Methods: HCV-RNA detection was performed in all serological samples of blood donors that tested positive using HCV Ultra ELISA. Determination of hyaluronan (HA) was performed in positive HCV samples using ELISA-like fluorometric method. The HA content was compared to HCV viral load, genotype of the virus, liver fibrosis as well as ALT and GGT liver biomarkers. Results: Persistently normal ALT (<40 U/L) and GGT (<50 U/L) serum levels were detected in 75% and 69% of the HCV-Infected blood donors, respectively. Based on ROC analysis, the HA value < 34.2 ng/mL is an optimal cut-off point to exclude HCV viremia (specificity = 91%, NPV = 99%). Applying HA value ≥34.2 ng/mL significant liver fibrosis (≥F2) can be estimated in 46% of the HCV-infected blood donors. HA serum level (≥34.2 ng/mL) associated with a high ALT level (>40 U/mL) can correctly identify HCV infection and probable liver fibrosis (sensitivity = 96% and specificity = 90%) in asymptomatic blood donors. Conclusions: A high level of HA (≥34.2 ng/mL) in association with ALT (≥40 U/L) in serum can provide a good clinical opportunity to detect HCV-infected asymptomatic persons that potentially require a liver biopsy confirmation and antiviral treatment to prevent the development of advanced liver fibrosis or cirrhosis.

Basic assessment on adding platelet measurement to legal health checkup in Japan: A cross-sectional and 20-year longitudinal study

“…Our results found only a small number of AST and/or AST abnormalities among subjects with virus hepatitis. It is noteworthy that transaminase levels are often within normal ranges, especially in chronic viral hepatitis, and the ALT levels are usually normal in the immune tolerant and inactivating carriers of chronic hepatitis B ( 17 , 18 ), chronic hepatitis C, the rate of those having normal ALT levels was reported to be 46–75% ( 19 , 20 ). Previously, Prati et al ( 21 ) reported that the cutoff of ALT normal range to detect HCV infection was 30 and 19 IU/L, in men and women, respectively.…”

Effect of Candesartan and Ramipril on Liver Fibrosis in Patients with Chronic Hepatitis C Viral Infection: A Randomized Controlled Prospective Study

“… 22 HA and TGF-β1 have been demonstrated as the most useful diagnostic and prognostic noninvasive biomarkers for hepatic fibrosis. 23 , 24 Furthermore, FIB-4 and APRI indices were reported to have a diagnostic accuracy for detecting liver fibrosis. 25 …”

“… 48 We reported also the existence of positive significant correlation between serum HA and liver stiffness, a result seems in accordance with the findings of other authors who reported that serum HA levels are related to stage of fibrosis and degree of necroinflammation. 23 …”

Hyaluronan in liver fibrosis: basic mechanisms, clinical implications, and therapeutic targets

“…For example, HA can identify asymptomatic HCV-infected patients from blood donors. 20 The combination of HA with cytokeratin-18 M30 improves to differentiate NAFLD patients with fibrosis from those without fibrosis. 21 Addition of HA to the currently available fibrosis scores to improve the prediction and diagnostic accuracy of cirrhosis and HCC is also of special interest.…”