WHO International Reference Panels: Collaborative Study to Evaluate a Hepatitis B Virus Genotype Panel

CAMPOS, R.H.; MBAYED, V.A.; TORRES, C.

2008-12-01

2009-04-01

Biomédica

Salud humana

The purpose of the Collaborative Study is to evaluate a plasma panel of different Hepatitis B Virus (HBV) genotypes using nucleic acid amplification technique (NAT) assays. The study includes the parallel testing of the 2nd International Standard for HBV DNA (97/750).During the WHO Consultation on Global Measurement Standards and their use in the in vitro Biological Diagnostic Field in June 2004 concern was raised that HBsAg test kits and NAT test kits for the detection of HBV DNA might be less efficient for some HBV genotypes other than A2, which is represented by the current WHO International Standard. The Paul-Ehrlich-Institut (PEI), as one of the three WHO Collaborating Centres involved in the Biological Standardization Programme, proposed projects to establish WHO International Reference Panels for HBV DNA and for HBsAg representing different genotypes of HBV. The projects were endorsed and assigned as a high priority by the WHO Expert Committee on Biological Standardization in October 2005.The candidate HBV genotype panel intended for use with HBV NAT assays has now been prepared (lyophilized material). It consists of 15 members and covers the most prevalent HBV genotypes (A-G). The study is designed to test the panel samples (15 lyophilized preparations) concurrently with the WHO International Standard (97/750).