Validation of immunoassay for the detection of hepatitis B virus surface antigen in plasma pools - Scientific guideline

This document describes methods to select and validate commercial qualitative immunoassay test kits for assessing contamination of plasma pools with hepatitis B virus surface antigen (HBsAg). It has been developed to respond to inadequacies in the validation of plasma pool testing for HBsAg observed during evaluation of dossiers.

Keywords: HBsAg, hepatitis B virus surface antigen immunoassays, validation, antibody detection, plasma, pool

Current effective version

Guideline on validation of immunoassay for the detection of hepatitis B virus surface antigen (HBSAG) in plasma pools

Adopted Reference Number: EMEA/CHMP/BWP/298390/2005 Legal effective date: 01/04/2007

Document history

Overview of comments received on draft guideline on validation of immunoassay for the detection of hepatitis B virus surface antigen (HBSAG) in plasma pools

Reference Number: EMEA/CHMP/BWP/94181/2006