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/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
NAT METHODS
Amplicor (19 labs), TMA assay (5 labs), In-house (7 labs)
Istituto Superiore di Sanità
Laboratory of Immunology
RESULTS
Genotype
(100 IU/mL)
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
Failing Lab
4
16
13
26
5
11
12
6
14
25
Neg
6
15
2
25
Istituto Superiore di Sanità
Laboratory of Immunology
CONCLUSIONS

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
Istituto Superiore di Sanità
Laboratory of Immunology