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 Istituto Superiore di Sanità Laboratory of Immunology
AIM OF THE EQA/4 STUDY • Assessing the proficiency of blood products manufacturer and blood centres in detecting by NAT the six major HCV genotypes 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 Istituto Superiore di Sanità Laboratory of Immunology
PANEL COMPOSITION 16 coded samples • 12 positive samples, containing genotypes 1 -6 with a nominal concentration of 100 IU/m. L – 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 NAT METHODS Amplicor (19 labs), TMA assay (5 labs), In-house (7 labs) Istituto Superiore di Sanità Laboratory of Immunology
RESULTS Genotype (100 IU/m. L) Sample code 1 9 and 12 60/60 (100) 2 4 and 7 60/60 (100) 3 2 and 13 60/60 (100) 4 1 and 16 58/60 (96. 7) 5 5 and 11 59/60 (98. 3) 6 3 and 14 59/60 (98. 3) negative 6, 8, 10, 15 2/120 (1. 7) Istituto Superiore di Sanità Positive/tested (%) Laboratory of Immunology
DISCREPANT RESULTS Genotype Sample code 4 16 13 26 5 11 12 6 14 25 Neg 6 15 Failing Lab 2 25 Istituto Superiore di Sanità Laboratory of Immunology
CONCLUSIONS ü This study represents the first one that included all the six major HCV genotypes ü Overall results can be considered satisfactory ü As the ability to detect all HCV genotypes is of crucial importance, next EQA studies should continue to include all six major HCV genotypes Istituto Superiore di Sanità Laboratory of Immunology
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