1. Italian EQA study for HCV RNA, HIV RNA and HBV DNA G. M. Bisso, K
Italian EQA study for HCV RNA, HIV RNA and HBV DNA G.M. Bisso, K.Cristiano,J. Saldanha, C. Mele, G. Pisani,M. Wirz and G. Gentili
Giulio Pisani
Biologicals Unit
Dept. of Infectious, Parasitic and Immune-mediated Diseases
Istituto Superiore di Sanità
Rome, Italy

2. AIM OF THE EQA STUDY
Assessing the proficiency of blood products manufacturer and blood centres in detecting by NAT the possible contamination of plasma with HCV, HIV and HBV

3. EQAs PARTICIPANTS 46 laboratories in the HCV EQA/5 study
35 laboratories in the HIV EQA/1 study
16 laboratories in the HBV EQA/1 study

4. EQAs PARTICIPANTS 46 laboratories 9 blood product manufacturers
2 from Germany
2 from Italy
1 from Argentina
1 from Austria
1 from Australia
1 from Spain
1 from Switzerland
1 diagnostic kits manufacturer
from U.S.A.
35 blood centres
28 from Italy
4 from Canada
3 from UK
1 OMCL

5. PANEL COMPOSITION HCV EQA/5 10 coded samples
8 positive samples, containing genotypes 1-6 with a nominal concentration of 100 IU/mL
genotype 4 and genotype 5 were present in duplicate
2 negative replicates

6. PANEL COMPOSITION HIV EQA/1 6 coded samples
2 replicates with a nominal concentration of 1,000 IU/mL
2 replicates with a nominal concentration of IU/mL
2 negative replicates

7. PANEL COMPOSITION HBV EQA/1 6 coded samples
2 replicates with a nominal concentration of 1,000 IU/mL
2 replicates with a nominal concentration of IU/mL
2 negative replicates

8. DISTRIBUTION OF THE PANELS
Before distribution, each EQA panel was tested in our lab
Results as expected
Samples shipped on dry ice
Up to two panels were sent to each lab

9. NAT METHODS Methods HCV EQA/5 HIV EQA/1 HBV EQA/1 Cobas Ampliscreen 13
HCV Cobas Amplicor v2.0 7
HCV Amplicor v2.0 2
Procleix HIV-1/HCV Assay 16
Procleix Ultrio Assay 1 3
Other kits
In-house 4
TOTAL 46 35

10. RESULTS HCV EQA/5 Genotype (100 IU/mL) Sample code Positive/tested (%)6
45/45
(100) 2 5 3 10 4
4 and 9
88/90
(97.8)
2 and 7
90/90
44/45
negative
3 and 8
(0)

11. RESULTS HIV EQA/1 IU/mL Sample code Positive/tested (%) 1000 2 and 4
70/70
(100)
100
1 and 6
63/70
(90)
Negative
3 and 5
0/70
(0)

12. RESULTS HBV EQA/1 IU/mL Sample code Positive/tested (%) 1000 3 and 6
32/32
(100)
100
1 and 4
Negative
2 and 5
0/32
(0)

13. CONCLUSIONS
HCV EQA/5 Improved proficiency of participants to detected all 6 genotypes at a concentration of 100 IU/mL: 95.6% of EQA/5 participants vs 83.8% of EQA/4 participants
HIV EQA/1 A concentration of 200 IU/mL would be
advisable as the minimal sensitivity
HBV EQA/1 A concentration lower than 100 IU/mL
could represent the appropriate minimal requirement