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

Current effective version

PDF iconAdopted guideline

Reference number CHMP/BWP/298390/05
Published 21/09/2006
Effective from 01/04/2007
Keywords HBsAg, hepatitis B virus surface antigen immunoassays, validation, antibody detection, plasma, pool
Description 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.

Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments

In operation: 01/04/2007–present


Published: 21/08/2006

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