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

HumanScientific guidelines

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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:

English (EN) (52.46 KB - PDF)

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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

English (EN) (84.57 KB - PDF)

Publicado por primera vez: Última actualización:
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