1 st international standard for hiv 1 rna nibsc code 97 656
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1 st International Standard for HIV-1 RNA NIBSC Code 97/656. CBER, CLB and NIBSC collaborated in development of HIV-1 International Standard for NAT Three candidate standards evaluated in collaborative study

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1 st international standard for hiv 1 rna nibsc code 97 656
1st International Standard for HIV-1 RNANIBSC Code 97/656
  • CBER, CLB and NIBSC collaborated in development of HIV-1 International Standard for NAT
  • Three candidate standards evaluated in collaborative study
  • WHO Expert Committee (ECBS) established candidate YY as 1st International Standard for HIV-1 RNA (code 97/656)
  • Assigned a concentration of 100,000 IU per vial/ml (1IU ~ 0.58 copies/ml)
  • YY was human HIV-1-positive plasmapheresis donation diluted in defibrinated plasma
  • Has recently been found positive for HBV DNA

SoGAT XVI

1 st international standard for hiv 1 rna code 97 656
1st International Standard for HIV-1 RNACode 97/656
  • In-house qualitative assay detected HBV DNA (David Padley, NIBSC)
  • Nested PCR positive for HBV DNA – estimated viral load at 3.5 x 104 amplifiable copies/ml (Alison Hardie, University of Edinburgh)
  • Procleix Triplex assay showed that 100 IU/ml dilution of HIV-1 International Standard contains 611 IU/ml HBV DNA (V Shyamala, Chiron Corporation)
    • What are the implications of this?

SoGAT XVI

1 st international standard for hiv 1 rna implications of hbv contamination
1st International Standard for HIV-1 RNA: Implications of HBV Contamination
  • For use in monovalent HIV-1 NAT or multivalent NAT assays that do not include HBV detection:
    • International Standard may still be used as directed
  • For use in multiplex assays that detect both HIV-1 RNA and HBV DNA :
    • 1st international Standard for HIV-1 may not be suitable for the quantitation of HIV-1 RNA
  • What difficulties will this cause for users?
  • Do we need to establish a second International Standard calibrated on the first?
  • If so, should we use candidate XX used in the collaborative study?

SoGAT XVI

development of 1 st international standard for hiv 1 rna1
Development of 1st International Standard for HIV-1 RNA

Candidate XX

Candidate YY

Candidate ZZ

--- bDN

--- Monitor

--Nuclisens

--- Abbott

--- in-house

SoGAT XVI

slide6

Distribution: Approx 240 vials/year

On present trend, Std will run out in 4 years, possibly sooner

SoGAT XVI

1 st international standard for hiv 1 rna implications of hbv contamination1
1st International Standard for HIV-1 RNA: Implications of HBV Contamination
  • If it is agreed that candidate XX be brought in as a replacement for 1st international Standard (YY)
    • we will need to carry out small comparability and stability study to confirm that performance is satisfactory
  • This can be carried out over next 6 months in time for approval at WHO ECBS meeting in 2004

SoGAT XVI

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