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    Equivalence of ELISpot Assays Demonstrated between Major HIV Network Laboratories

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    The final, definitive version of this paper has been published in PLOS ONE Vol. 5 Issue 12 (December 2010) DOI:10.1371/journal.pone.0014330. All rights reserved. (585.8Kb)
    Date
    2010-12-14
    Author
    Gill, Dilbinder K.
    Huang, Yunda
    Levine, Gail L.
    Sambor, Anna
    Carter, Donald K.
    Sato, Alicia
    Kopycinski, Jakub
    Hayes, Peter
    Hahn, Bridget
    Birungi, Josephine
    Tarragona-Fiol, Tony
    Wan, Hong
    Randles, Mark
    Cooper, Andrew Raxworthy
    Ssemaganda, Aloysius
    Clark, Lorna
    Kaleebu, Pontiano
    Self, Steven G.
    Koup, Richard
    Wood, Blake
    McElrath, M. Juliana
    Cox, Josephine H.
    Hural, John
    Gilmour, Jill
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    Abstract
    Background: The Comprehensive T Cell Vaccine Immune Monitoring Consortium (CTC-VIMC) was created to provide standardized immunogenicity monitoring services for HIV vaccine trials. The ex vivo interferon-gamma (IFN-c) ELISpot is used extensively as a primary immunogenicity assay to assess T cell-based vaccine candidates in trials for infectious diseases and cancer. Two independent, GCLP-accredited central laboratories of CTC-VIMC routinely use their own standard operating procedures (SOPs) for ELISpot within two major networks of HIV vaccine trials. Studies are imperatively needed to assess the comparability of ELISpot measurements across laboratories to benefit optimal advancement of vaccine candidates. Methods: We describe an equivalence study of the two independently qualified IFN-g ELISpot SOPs. The study design, data collection and subsequent analysis were managed by independent statisticians to avoid subjectivity. The equivalence of both response rates and positivity calls to a given stimulus was assessed based on pre-specified acceptance criteria derived from a separate pilot study. Findings: Detection of positive responses was found to be equivalent between both laboratories. The 95% C.I. on the difference in response rates, for CMV (21.5%, 1.5%) and CEF (20.4%, 7.8%) responses, were both contained in the prespecified equivalence margin of interval [215%, 15%]. The lower bound of the 95% C.I. on the proportion of concordant positivity calls for CMV (97.2%) and CEF (89.5%) were both greater than the pre-specified margin of 70%. A third CTC-VIMC central laboratory already using one of the two SOPs also showed comparability when tested in a smaller sub-study. Interpretation: The described study procedure provides a prototypical example for the comparison of bioanalytical methods in HIV vaccine and other disease fields. This study also provides valuable and unprecedented information for future vaccine candidate evaluations on the comparison and pooling of ELISpot results generated by the CTC-VIMC central core laboratories.
    Use this URI to cite this item:
    https://hdl.handle.net/20.500.11951/332
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