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

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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

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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

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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

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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

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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

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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
  100 IU/mL
• 2 negative replicates

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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
  100 IU/mL
• 2 negative replicates

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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

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NAT METHODS
Methods HCV EQA/5 HIV EQA/1 HBV EQA/1
Cobas Ampliscreen 13 13 5
HCV Cobas Amplicor v2.0 7
HCV Amplicor v2.0 2
Procleix HIV-1/HCV Assay 16 16
Procleix Ultrio Assay 1 1 3
Other kits 1 1
In-house 7 4 7
TOTAL 46 35 16
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RESULTSHCV EQA/5
Genotype (100 IU/mL) Sample code Positive/tested ()
1 6 45/45 (100)
2 5 45/45 (100)
3 10 45/45 (100)
4 4 and 9 88/90 (97.8)
5 2 and 7 90/90 (100)
6 1 44/45 (97.8)
negative 3 and 8 45/45 (0)
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RESULTSHIV 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)
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RESULTSHBV EQA/1
IU/mL Sample code Positive/tested ()
1000 3 and 6 32/32 (100)
100 1 and 4 32/32 (100)
Negative 2 and 5 0/32 (0)
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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