Evaluation of Candidate Standard XX (97/650)

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Evaluation of Candidate Standard XX (97/650) Clare Davis Division of Retrovirology National Institute for Biological Standards and Control (NIBSC) UK SoGAT Paris 2004

1st International Standard for HIV-1 RNA (NIBSC code 97/656) Established as International Standard in 1999 (Holmes et al, 2001). Assigned a concentration of 100,000 IU per vial/ml. Based on HIV-1 PCR positive, antibody negative plasmapheresis donation. Virus diluted 1:312.5 in base matrix (defibrinated plasma). 2400 vials freeze-dried. Held at -200C. Preparation showed good stability and correlation amongst assays. Discussions at SoGAT – Jul 2003 (PEI) raised: Low Stocks (~ 650). Presence of HBV DNA – problematical for multiplex assays. SoGAT Paris 2004

--- bDNA --- Monitor --Nuclisens --- Abbott --- in-house SoGAT Paris 2004

Re-evaluation of Candidate XX Non-syncitium inducing HIV-1 genotype B field isolate field isolate (donated by Dr. P. Simmonds). Supplied as a low passage virus. Further propagated on human PBMC’s, supernatant stored in LN2. Virus diluted 1:250 in pooled human plasma. 2200 vials of material freeze-dried. SoGAT Paris 2004

Study Details Study purpose:- 9 Laboratories participating. Calibrate XX against HIV-1 RNA International Standard. Confirm stability of XX Determine values in current assays 9 Laboratories participating. International Standard and Candidate XX randomly coded. Participants asked to test samples in 3 independent assays. Initially 10 fold dilution Then 2 subsequent assays half log dilutions around the end point. NIBSC to analyse data. SoGAT Paris 2004

Preliminary analysis of data so far….. Quantitative Lab Number Assay Used Sample A (copies/ml Log 10) Sample B 7 COBAS Taq Man 5.50 5.07 22 Amplicor 5.55 4.96 58 bDNA V3 5.21 4.69 73 COBAS Amplicor 5.84 5.26 Overall Mean 5.52 4.99 Values obtained in previous study 5.31 4.73 SoGAT Paris 2004

(log 10 detectable units/ml) Qualitative Lab Number Assay Used Sample A (log 10 detectable units/ml) Sample B 70 In house 4.69 71 5.36 4.11 72 5.15 5.29 Overall Mean 5.06 4.70 Values obtained in previous study 4.70 4.22 SoGAT Paris 2004

Conclusion Preliminary analysis of data shows good correlation with previous study. Hope to submit report to ECBS Aug 04. Please return any outstanding data to us by end Jun 04. SoGAT Paris 2004