Anti-HCV Core Protein Monoclonal antibody, Clone C057M

Background: The measurement of anti-HCV antibodies using immunological methods and the confirmation of viral nuclear acid based on molecular methods is important in diagnosis and follow-up of the HCV infection. Objectives: In this study, we aimed to analyse HCV core Antigen positivity among anti-HCV antibody positive sera to determine the significance of testing of HCV core Ag for the laboratory diagnosis of HCV infection, by considering the correlation between serum HCV core Ag and HCV RNA levels. Methods: 115 patients suspected of having hepatitis C and who were positive for anti-HCV antibody were investigated using chemiluminescent and molecular methods. Anti-HCV antibody, HCV core Ag and HCV RNA levels were detected by the Vitros ECiQ immunodiagnostic system, Architect i2000 system and RT-PCR, respectively. Results: The sensitivity, specificity, positive and negative predictive values and accuracy rate of HCV core Antigen assay were detected as 86.5%(83/96), 100%(19/19), 100%(83/83), 59.4%(19/32), 88.7%(102/115) respectively. Conclusion: HCV core Ag assay could be used for diagnosis of HCV infection as it is easy to perform, cost-effective, has high specificity and positive predictive value. However, it should be kept in mind that it may have lack of sensitivity and negative predictive value.

Background In settings such as needle-stick injuries or intravenous drug abuse, immediate knowledge of the anti-hepatitis C virus (HCV) serostatus instead of waiting for the results of a laboratory-based test can be important to guide further medical procedures and appropriate hygienic advises. Thus, a rapid on-site anti-HCV test was evaluated in daily clinical routine and compared with a laboratory-based certified assay. Patients and methods Ten microliters of serum or EDTA whole blood was analyzed using a chromatographic immunoassay (Toyo anti-HCV test). Results were available on-site 5-15 min after sample centrifugation. The Architect anti-HCV test served as a reference method. Results Sera of 189 patients were analyzed (without HCV infection: n = 105; HCV infection: n = 84). The assay was evaluable in 185 cases (98%). The sensitivity and specificity were 99 and 88%, respectively. With EDTA whole blood, the test was evaluable in 47/52 samples (90%). Forty-six of 47 evaluable EDTA tests were concordant with serum results. The one HCV patient with an unevaluable serum test was diagnosed correctly with the EDTA sample. Conclusion The rapid chromatographic anti-HCV immunoassay has limited specificity, which impairs clinical practicability. A positive result warrants re-evaluation with a certified serologic assay. Eur J Gastroenterol Hepatol 25: 416-420 (C) 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. European Journal of Gastroenterology & Hepatology 2013, 25:416-420