1 / 13

Giulio Pisani Biologicals Unit Dept. of Infectious, Parasitic and Immune-mediated Diseases

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.

laksha
Télécharger la présentation

Giulio Pisani Biologicals Unit Dept. of Infectious, Parasitic and Immune-mediated Diseases

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

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

  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. 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 EQAs PARTICIPANTS 46 laboratories

  5. 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 PANEL COMPOSITION HCV EQA/5 10 coded samples

  6. 2 replicates with a nominal concentration of 1,000 IU/mL 2 replicates with a nominal concentration of 100 IU/mL 2 negative replicates PANEL COMPOSITION HIV EQA/1 6 coded samples

  7. 2 replicates with a nominal concentration of 1,000 IU/mL 2 replicates with a nominal concentration of 100 IU/mL 2 negative replicates PANEL COMPOSITION HBV EQA/1 6 coded samples

  8. 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 DISTRIBUTION OF THE PANELS

  9. NAT METHODS

  10. RESULTSHCV EQA/5

  11. RESULTSHIV EQA/1

  12. RESULTSHBV EQA/1

  13. 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 CONCLUSIONS • 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

More Related