Equivalence of ELISpot Assays Demonstrated between Major HIV Network Laboratories

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dc.contributor.authorGill, Dilbinder K.
dc.contributor.authorHuang, Yunda
dc.contributor.authorLevine, Gail L.
dc.contributor.authorSambor, Anna
dc.contributor.authorCarter, Donald K.
dc.contributor.authorSato, Alicia
dc.contributor.authorKopycinski, Jakub
dc.contributor.authorHayes, Peter
dc.contributor.authorHahn, Bridget
dc.contributor.authorBirungi, Josephine
dc.contributor.authorTarragona-Fiol, Tony
dc.contributor.authorWan, Hong
dc.contributor.authorRandles, Mark
dc.contributor.authorCooper, Andrew Raxworthy
dc.contributor.authorSsemaganda, Aloysius
dc.contributor.authorClark, Lorna
dc.contributor.authorKaleebu, Pontiano
dc.contributor.authorSelf, Steven G.
dc.contributor.authorKoup, Richard
dc.contributor.authorWood, Blake
dc.contributor.authorMcElrath, M. Juliana
dc.contributor.authorCox, Josephine H.
dc.contributor.authorHural, John
dc.contributor.authorGilmour, Jill
dc.date.accessioned2018-08-06T10:01:22Z
dc.date.available2018-08-06T10:01:22Z
dc.date.issued2010-12-14
dc.descriptionThis study examined the Comprehensive T Cell Vaccine Immune Monitoring Consortium (CTC-VIMC) which was created to provide standardized immunogenicity monitoring services for HIV vaccine trialsen_US
dc.description.abstractBackground: 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.en_US
dc.identifier.citationGill et al. Equivalence of ELISpot Assays Demonstrated between Major HIV Network Laboratories. PLOS ONE Vol. 5 Issue 12 (December 2010) DOI:10.1371/journal.pone.0014330en_US
dc.identifier.urihttps://hdl.handle.net/20.500.11951/332
dc.language.isoenen_US
dc.publisherPLOS ONEen_US
dc.subjectT-cell Vaccine Immuneen_US
dc.subjectPrimary immunogenicityen_US
dc.subjectHIV vaccineen_US
dc.titleEquivalence of ELISpot Assays Demonstrated between Major HIV Network Laboratoriesen_US
dc.typeArticleen_US
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