The performance of Hepatitis C virus (HCV) test systems was evaluated for use in a screening algorithm for a high prevalence, asymptomatic population. The version 2.0 (Abbott) and 3.0 (Ortho) EIAs, the version 2.0 and 3.0 supplemental RIBA (Chiron), and the version 2.0 qualitative HCV PCA (Roche) were used to obtain a diagnosis of HCV Infection. 944 serum specimens were screened for HCV antibody. The sensitivity/specificity of the 2.0 and 3.0 EIAs were 98.4%/99.7% and 100%/99.1%, respectively. The RIBA 2.0 and 3.0 assays confirmed most (>98%) of the EIA positive results, although there were some specimens with indeterminate results. The RIBA 3.0 assay gave fewer indeterminate results and more positive results than the 2.0 assay. Positive qualitative HCV PCR assay results confirmed 81.6% of the EIA positive samples. RIBA was used to confirm the EIA positive- PCR negative samples. A combination of the version 3.0 EIA, 3.0 RIBA and 2.0 PCR were necessary to identify all HCV-infected individuals. The performance of qualitative HCV RNA PCR on all EIA repeatably positive samples followed by RIBA on PCR negative samples was a cost-effective algorithm and provided additional, clinically useful, information.
Learning Objectives: 1) At the end of this presentation, participants will be able to discuss screening methodologies for HCV serostatus. 2) At the end of this discussion, participants will be able to identify a cost-effective algorithm for screening populations for HCV.
Keywords: Hepatitis C,
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.