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

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Current effective version

Adopted guideline

Reference numberCHMP/BWP/298390/05
Published21/09/2006
Effective from01/04/2007
KeywordsHBsAg, hepatitis B virus surface antigen immunoassays, validation, antibody detection, plasma, pool
DescriptionThis 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

Adopted guideline


Overview of comments

In operation: 01/04/2007–present


Published: 21/08/2006


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