1 / 10

SoGAT XVII/Paris, 2004

Proficiency Testing of In-House Developed HIV-1 NAT for Blood Screening Michael Chudy, Paul-Ehrlich-Institut Division of Virology, Section of Molecular Pathology Langen, Germany; Email: chumi@pei.de. SoGAT XVII/Paris, 2004. PEI.

fonda
Download Presentation

SoGAT XVII/Paris, 2004

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. Proficiency Testingof In-House Developed HIV-1 NAT for Blood Screening Michael Chudy, Paul-Ehrlich-Institut Division of Virology, Section of Molecular Pathology Langen, Germany; Email: chumi@pei.de SoGAT XVII/Paris, 2004

  2. PEI German Regulations for Blood Components and FFP: Implementation of HIV-1 NAT • BAnz. [Fed. Gazette] No 90, 9506; 05/16/2001 • detection limit of HIV-1 RNA: 10,000 IU/ml for single donation • prospective implementation 01/01/2002 • 08/27/2001: PEI announcement • HIV-1 subtypes: M group • PEI collaborative study of in-house NAT assays for detection of HIV-1 and HCV RNA;participation on voluntary basis (10/01/2001) • HIV-1 NAT implementation postponed

  3. PEI Collaborative Study: In-house NAT Assays

  4. PEI Collaborative Study 2001: Conclusions • HCV NAT (in-house): • homogeneous results (sensitivity, specificity, and proficiency) • no differences between SD- and MP-testing • HIV-1 NAT (in-house): • results less homogeneous • further improvements and validation • regular proficiency studies for in-house NAT assays organised by PEI • acceptance: successful participation

  5. PEI German Regulations for Blood Components and FFP: Implementation of HIV-1 NAT • BAnz. [Fed. Gazette] No 103, 12269; 06/05/2003 • implementation 05/01/2004 • validation of in-house assays • acceptance of in-house assays: successful participation in PEI proficiency study

  6. PEI Proficiency Study for In-house HIV-1 NAT Assays: : Objective Evaluation of in-house NAT assays for detection of HIV-1 in blood donations: • analytical sensitivity • subtype sensitivity • specificity • proficiency

  7. PEI Proficiency Study for In-house HIV-1 NAT Assays: Study Design • Focus on the detection limit: • 10,000 IU HIV1-RNA/ml single donation • Materials • Reference preparations (WHO: 31,600, 10,000 2x, 3,160 IU/ml/PEI: 10,000 IU/ml) • HIV-1 subtypes (A, C, CRF_AE, G, H; each 10,000 IU/ml) • NHP pool (2x) • Simulation of the pool size (volume, dilution) • Lab and sample encoding • Samples frozen at -80°C/shipment on dry ice • Results: reactive/non-reactive (data sheet)

  8. PEI Proficiency Study for In-house HIV-1 NAT Assays: Participants Overall 30 participants • 29 labs: blood screening; 2 labs only pooling/1 lab: manufacturer of plasma prod. • SD 1x; MP-8 1x; MP-10 3x; MP-15 2x, MP-20 4x, MP-24 2x, MP-40 1x, MP-48 5x; and MP-96 11 x • 7 labs with virus enrichment • NA extraction: 14 labs Qiagen/5 labs Roche/4 labs NucliSens/5 labs other • 23 real-time PCR (20x TaqMan/3x LC Hybr.) • 2x CA HIV-1 Monitor/3x RT-PCR +Gene Scanning

  9. Proficiency Study In-house HIV-1 NAT: Results

  10. PEI Proficiency Study for In-house HIV-1 NAT Assays (2003): Conclusions • Results more homogeneous compared to the results of the study in 2001 • No differences in respect with the used pool size • Due to the test results, 2 test labs switched to commercial assays • Assessment of in-house assays: validation studies and successful participation in proficiency study • Conclusion: In-house assays are suitable for blood screening • CE-marking of in-house assays: open question

More Related