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Diagnostic Accuracy of Serum Hyaluronan for Detecting HCV Infection and Liver Fibrosis in Asymptomatic Blood Donors
Authors:Itatiana F Rodart  Madalena M Pares  Aline Mendes  Camila M Accardo  Joo R M Martins  Cleidenice B Silva  Fabrício O Carvalho  Jos A Barreto  Mitermayer G Reis  Ivarne L S Tersariol  Helena B Nader
Institution:1.Departamento de Bioquímica, Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP), São Paulo 04021-001, Brazil; (I.F.R.); (A.M.); (C.M.A.); (J.R.M.M.);2.Associação Beneficente de Coleta de Sangue (COLSAN), São Paulo 04038-000, Brazil; (M.M.P.); (C.B.S.); (F.O.C.); (J.A.B.);3.Laboratório de Hepatites Virais, Centro de Pesquisas Gonçalo Muniz, Fundação Oswaldo Cruz, Salvador 40296-710, Brazil;
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.
Keywords:serum hyaluronan  diagnostic accuracy  liver fibrosis  liver enzymes  HCV infection  blood donors
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