WHO/BS/2016.2291 Collaborative Study to Evaluate the Proposed WHO 4th IS for Hepatitis B Virus (HBV) DNA for Nucleic Acid Amplification Technique (NAT) based assays

Overview

This report describes the collaborative study evaluation of the replacement 4 th WHO International Standard for hepatitis B virus (HBV) DNA for the calibration of secondary reference preparations for HBV nucleic acid amplification techniques (NAT). The candidate 4th International Standard HBV DNA was prepared and evaluated as part of the collaborative study to establish the WHO 3 rd International Standard for HBV DNA in 2011. The lyophilized preparation comprises a dilution of the same HBV DNA-positive plasma sample as used for the previous HBV International Standards, in pooled human plasma. In this collaborative study, thirteen laboratories from seven countries evaluated the suitability of the candidate using their routine HBV NAT-based assay. The candidate NIBSC code 10/266 (sample 2) was evaluated alongside the 3rd HBV WHO International Standard, NIBSC code 10/264 (sample 1), three HBV reference preparations (samples 3-5) and three HBV-positive plasma samples comprising different HBV genotypes (samples 6-8). A range of HBV NAT assays were used in the evaluation, the majority of which were commercial quantitative assays based on real-time PCR technology.