Abstract

BLANCO-RIVERO, María Claudia et al. Evaluation of new immunoassay for detection of antibodies against hepatitis C virus. Acta bioquím. clín. latinoam. [online]. 2008, vol.42, n.3, pp.325-332. ISSN 0325-2957.

The performance of a new third-generation Anti-HCV, HCV ELISA third-generation (Wiener-lab. Rosario. Argentina), was evaluated. This kit presents sample addition monitoring and process control. Sensibility, specificity and precision of HCV ELISA 3ª generation were evaluated by means of 5 seroconversion panels, 8 performance panels, 1 worldwide HCV performance panel (which includes different HCV genotypes), on 546 samples of patients infected with HCV, 556 samples containing potentially interfering substances, and 3024 samples of persons not infected with HCV. Sensibility was 99.72% on performance panels and samples of HCV infected patients, and 100% on samples of patients infected with different genotypes. The specificity obtained from samples from blood donors and health centers was 99.50%. Finally, in precision studies the intra-assay coefficient of variation found was smaller than 10% and the inter-assay CV was smaller than 15% for weak reactive samples. In summary, HCV ELISA 3ª generation developed by Wiener-lab presents an adequate performance for the diagnosis of hepatitis C virus infection in clinical laboratory and blood donations screening.

Keywords : Hepatitis C virus; Anti-hepatitis C virus antibodies; Enzyme immunoassay; Serologic screening; Serologic diagnosis.

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