Detection of hepatitis C virus core antigen as an alternative method for diagnosis of hepatitis C virus infection in blood donors negative for hepatitis C virus antibody.

Background: Screening of blood donors in many countries is based on the use of serologic assays to detect specific anti-HCV antibodies (HCV Ab), but it lacks detection sensitivity. So, HCV RNA detection using the current gold standard real-time PCR is a must to rule out HCV infection with the main disadvantage being of high cost. HCV core antigen (HCV-c-Ag) immunoassay is proposed as a more cost efficient alternative to HCV RNA detection with PCR.

Aim: To evaluate the effectiveness of HCV-c-Ag detection as a cheap alternative to HCV RNA (PCR) in diagnosis of HCV infection in blood donors who are HCV Ab negative.

Methods And Results: One hundred eighty-six volunteer blood donors who tested negative for HCV Ab were examined for HCV-c-Ag. Seven cases out of these 186 cases were HCV-c-Ag positive (4%). HCV RNA detection (PCR technique) was done to 30 cases (seven cases who test positive for HCV-c-Ag and 23 cases who test negative). Six out of the seven cases who were HCV-c-Ag positive (86%) were HCV RNA positive. Twenty-two cases out of the 23 cases who were HCV-c-Ag negative (96%) were HCV RNA negative.

Conclusion: HCV-c-Ag detection is an efficient method for diagnosis of HCV infection during screening of blood donors with high specificity (95.6%) and high negative predictive value (95.6%).