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

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.

Keywords: Validation, immunoassay, antibody detection, immunodeficency, virus, plasma, pool, anti-HIV

Current effective version

Guideline on validation of immunoassay for the detection of antibody to human immunodeficiency virus (anti-HIV) in plasma pools

Adopted Reference Number: EMEA/CHMP/BWP/298388/05 Legal effective date: 01/04/2007

Document history

• Overview of comments received on draft guideline on validation of immunoassay for the detection of antibody to human immunodeficiency virus (anti-HIV) in plasma pools