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

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Current effective version

Adopted guideline

Reference numberCHMP/BWP/298388/05
Effective from01/04/2007
KeywordsValidation, immunoassay, antibody detection, immunodeficency, virus, plasma, pool, anti-HIV
DescriptionThis 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

Adopted guideline

Overview of comments

In operation: 01/04/2007–present

Published: 21/08/2006

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