Validation of immunoassay for the detection of antibody to human immunodeficiency virus in plasma pools

Current effective version

PDF iconAdopted guideline

Reference number CHMP/BWP/298388/05
Published 21/08/2006
Effective from 01/04/2007
Keywords Validation, immunoassay, antibody detection, immunodeficency, virus, plasma, pool, anti-HIV
Description This document describes methods to select and validate commercial qualitative immunoassay test kits for assessing contamination of plasma pools with antibodies to HIV 1 and 2. It has been developed to respond to inadequacies in the validation of plasma pool testing for anti-HIV 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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