Development of a simple restriction fragment length polymorphism (RFLP) based assay for HCV genotyping and comparative analysis with genotyping and serotyping tests.

The distribution between the different hepatitis C virus genotypes and subtypes has potentially important clinical and epidemiological implications. With this view a simple restriction fragment length polymorphism (RFLP) based assay was developed to identify the three major genotypes, 1, 2 and 3 and distinguish subtype 1a from 1b. This RFLP test uses a combination of three restriction endonuclease digestions, BstN1, BstU1 and Sau3a, respectively. Comparison with a 5'UTR based assay (LiPA), showed a 98% concordance with the RFLP based assay. In addition, good concordance is shown between these data and those obtained with a serological assay based on NS4 peptides.