New approaches in in-vitro diagnosis of Hepatitis C infections: The diagnostic performance of new hepatitis C virus core antigen detection test

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Background: There are problems currently in the diagnosis of hepatitis C infections We aimed to investigate the diagnostic performance of new HCV Ag (Abbott Diagnostic, Germany.

Methods: All of the study cases were applied to the 5stanbul University Microbiology and Clinical Microbiology Department and to the Düzen laboratory between February 2008-March 2009. Molecular (real-time PCR) and serological methods (Micro-ELISA) were applied to the all of the cases, 123 HCV RNA-positive and anti-HCV positive cases, 48 HCV RNA negative and anti-HCV negative cases were included as the study and negative control groups, respectively. We evaluated sensitivity, specificity, positive predictive (PPV) and negative predictive (NPV) values, accuracy and kappa values of antigen detection HCV Ag kit which includes monoclonal anti-HCV antibodies against HCV core antigen coated on the solid phase.

Results: Sensitivity, specificity, PPV, NPV, accuracy and kappa values were evaluated as 94.3%, 97.9%, 99.1%, 87%, 95.3% and 88%, respectively for HCV Ag kit.

Viral load distrubition and HCV Core Ag results of HCV RNA Positive Patients

Conclusion: As a result, the diagnostic performance parameters of recently developed HCVAg kit have not satisfactory results because false negative ratio was 5% and NPV was 87%. We suggest that this situation is related with unsufficient analytic sensitivity especially for HCV cases which have a 2000 IU/ml and below viral load. We suggest that the re-evaluation of the sensitivity of this kit will be usefull for blood screening.