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

Abstract

Background: 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.

Objectives: Performance of the deep sequencing-based ViroKey® SQ FLEX Genotyping Assay for the determination of HBV genotypes and resistance profiles were evaluated.

Patients and methods: 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).

Results: 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.

Conclusions: The deep sequencing-based ViroKey® SQ FLEX Genotyping Assay can be confidently used in clinical practice for hepatitis B genotyping and resistance testing.