Concordance between hepatitis C virus serotyping assays

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Abstract
Hepatitis C virus testing has evolved from a simple enzyme-linked immunosorbent assay (ELISA) to complex molecular tests including qualitative and quantitative polymerase chain reaction (PCR) as well as multiple methods to determine geno and serotypes. Serotyping assays have been described and are being further refined to aid describing the epidemiology of hepatitis C virus (HCV) infection and may have a role in predicting response treatment. This study describes the concordance between two serotyping assay systems, a recombinant immunoblot assay Chiron RIBA Strip Immunoblot Assay (SIA) and a more competitive ELISA peptide assay, using PCR as the standard. Serotype was successfully determined in 144/202 (71%) patients by the Murex ELISA assay and 179/202 (89%) by the Chiron strip immunoblot assay (SIA) assay (P < 0.001). Concordance between restriction fragment length polymorphism (RFLP) and the Murex assay was 139/144 (97%) between RFLP and the Chiron SIA was 171/179 (96%) and between the Murex and Chiron SIA was 136/144 (94%). These assays provided a reliable, simple, and rapid method of determining HCV serotype.