Performance evaluation of a fully automated deep sequencing platform for hepatitis B genotyping and resistance testing

Treatment of chronic hepatitis B infection requires lifelong administration of nucleos(t)ide analogues with a high barrier to resistance and effective viral suppression. The major limitation of lifelong therapy is the possible selection of drug-resistant hepatitis B virus (HBV) strains. International Liver Society guidelines recommend that hepatitis B resistance testing must be performed by a reference laboratory. Performance of the deep sequencing-based ViroKey® SQ FLEX Genotyping Assay for the determination of HBV genotypes and resistance profiles were evaluated. Plasma samples collected from patients with chronic hepatitis B have been sequenced by two methods including Sanger (population) sequencing of a portion of the P/S overlapping gene and the deep sequencing-based ViroKey® SQ FLEX Genotyping Assay (Vela Diagnostics). A high concordance rate with population sequencing was found regardless of HBV genotypes. Deep sequencing with the Sentosa platform was more sensitive than population sequencing in detecting minor variant populations. The deep sequencing-based ViroKey® SQ FLEX Genotyping Assay can be confidently used in clinical practice for hepatitis B genotyping and resistance testing.