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External quality assessment for detection by NAT of the six major HCV genotypes

External quality assessment for detection by NAT of the six major HCV genotypes. M Wirz*, GM Bisso*, K Cristiano*, G Gentili*, C Mele*, G Pisani*, J Saldanha° * Laboratory of Immunology, Istituto Superiore di Sanità, Rome, Italy ° Canadian Blood Services, Ottawa, canada.

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External quality assessment for detection by NAT of the six major HCV genotypes

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  1. External quality assessment for detection by NAT of the six major HCV genotypes M Wirz*, GM Bisso*, K Cristiano*, G Gentili*, C Mele*, G Pisani*, J Saldanha° * Laboratory of Immunology,Istituto Superiore di Sanità, Rome, Italy ° Canadian Blood Services, Ottawa, canada

  2. Assessing the proficiency of blood products manufacturer and blood centres in detecting by NAT the six major HCV genotypes AIM OF THE EQA/4 STUDY 31 laboratories participating in the study from Argentina, Austria, Australia, Canada, Germany, Italy, Switzerland, UK and USA • 8 blood product manufacturers • 2 diagnostic kits manufacturers • 21 blood centres

  3. 16 coded samples 12 positive samples, containing genotypes 1-6 with a nominal concentration of 100 IU/mL HCV RNA ISS 0498 (genotype 1) (Vox Sang 2000; 78: 217-224) HCV genotypes 2-6 kindly provided by John Saldanha (Vox Sang 2003; 84: 20-27) 4 negative replicates PANEL COMPOSITION NAT METHODS Amplicor (19 labs), TMA assay (5 labs), In-house (7 labs)

  4. RESULTS

  5. Genotype Sample code Failing Lab 4 16 13 26 5 11 12 6 14 25 Neg6 2 15 25 DISCREPANT RESULTS

  6. This study represents the first one that included all the six major HCV genotypes Overall results can be considered satisfactory As the ability to detect all HCV genotypes is of crucial importance, next EQA studies should continue to include all six major HCV genotypes CONCLUSIONS

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