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

• Published in: Vox sanguinis 2001-10, Vol.81 (3), p.143-147
• Main Authors: Gentili, G., Pisani, G., Bisso, G., Cristiano, K., Wirz, M., Mele, C.
• Format: Article
• Language: English
• Subjects: Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; blood products; Blood Specimen Collection - standards; Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis; Diagnostic Errors; external quality assessment; HCV RNA; Hepacivirus - genetics; Hepatitis C; Hepatitis C - diagnosis; Hepatitis C - transmission; Hepatitis C - virology; Humans; Italy; Medical sciences; Nucleic Acid Amplification Techniques - methods; Nucleic Acid Amplification Techniques - standards; Observer Variation; plasma pool testing; Quality Control; Reagent Kits, Diagnostic; Reference Standards; RNA, Viral - analysis; Transfusions. Complications. Transfusion reactions. Cell and gene therapy
• ISSN: 0042-9007; 1423-0410
• DOI: 10.1046/j.1423-0410.2001.00103.x

Background and Objectives 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. Materials and Methods A reference HCV RNA panel calibrated in international units (IU) was sent to each participant to be tested according to the validated procedure they routinely used in plasma pool testing. The panel consisted of 20 coded samples, four of which were obtained from a negative plasma pool. The remaining 16 samples, prepared by diluting the national reference preparation (ISS HCV RNA 0498), represented four half‐log dilution series, each consisting of four samples containing 100, 32, 10 and 3·2 IU/ml of HCV RNA. Results The overall performance of the laboratories was very satisfactory. All laboratories correctly identified the negative samples. The 100‐ and 32‐IU/ml samples were both detected in 98·4% of the assays, while the 10‐ and 3·2‐IU/ml samples were detected in 73·4 and 50·0% of the assays, respectively. No substantial differences were observed between in‐house procedures and commercial kits. Conclusion This external quality assessment study showed that manufacturers of blood products have reached a high level of proficiency that fully complies with the European Pharmacopoeia requirements. This finding is reassuring in the context of the safety of blood products.