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Hepatitis C virus testing of plasma pools by nucleic acid amplification technology: external quality assessment

Since 1 July 1999, in accordance with European regulations, only batches of blood products obtained from plasma pools tested and found to be non‐reactive for hepatitis C virus (HCV) RNA are being released. As monitoring the performance of manufacturers involved in plasma pool testing is important to ensure reliable amplification techniques, the Istituto Superiore di Sanità, as the Italian regulatory authority, organized an external quality assessment study.