WHO/BS/2023.2447 WHO 5th IS for HBV DNA for NAT

Overview

This report describes the collaborative study evaluation of a replacement 5 th WHO International Standard for hepatitis B virus (HBV) DNA for the calibration of secondary references for HBV nucleic acid amplification techniques (NAT). The candidate 5 th HBV International Standard 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, ten laboratories from seven countries evaluated the suitability of the candidate using their routine HBV NAT-based assay.