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Infections with hepatitis C virus (HCV) are pandemic. The WHO estimates a worldwide prevalence of 3%. For monitoring of chronic hepatitis C, assays for direct virus detection are employed. In this study, an improved version of the Ortho® trak-C assay™ (Ortho-Clinical Diagnostics, Raritan, NJ) for detection of the HCV core antigen was evaluated. Precision, interassay, and intraassay variation were determined and a total of 115 clinical specimens were investigated. When precision of the Ortho® trak-C assay™ was evaluated, the assay gave positive results in those samples above the expected detection limit. Interassay coefficients of variation ranged between 6–25%, while intra-assay coefficients of variation were found to be between 19%. When clinical samples were tested with the Ortho trakC assay and compared with results obtained with the Cobas Ampli Prep/Cobas Amplicor HCV Monitor Test (Roche Molecular Systems, Inc., Branchburg, NJ), 66% of all positive values were found to be within a +-0.5 log difference of the level obtained with the molecular assay. In conclusion, the Ortho® trak-C™ assay showed a good test performance and proved to be suitable for the routine-diagnostic laboratory.

Evaluation of total Hepatitis C virus core antigen quantification / Evaluierung eines Tests zur Quantifizierung des Hepatitis C Kern Antigens