Cited by 68HIV Research and TreatmentStatistical Methods in Clinical TrialsStatistical Methods in Epidemiology

Statistical positivity criteria for the analysis of ELISpot assay data in HIV-1 vaccine trials

Moodie, Zoe, Huang, Yunda, Gu, Lin, Hural, John, Self, Steven G.·2006·Journal of Immunological Methods

Abstract

The enzyme-linked immunospot (ELISpot) assay is one of the leading technologies used to measure cellular responses in many settings including HIV vaccine clinical trials. HIV-1-specific effector T lymphocyte responses are considered necessary in the control of infection. Accurate measurement and summary of cellular immune responses are critical to HIV research. ELISpot assay readout is often dichotomized into positive/negative responses according to some pre-specified criteria. Given the increase in the number of replicates used for each stimulation with current assay configurations in the HIV Vaccine Trials Network (HVTN) laboratories, a new approach is now possible. We propose an objective criteria based on a hypothesis-driven method that controls the false positive rate while maintaining sensitivity to each of the antigen-specific responses under study. The new approach is compared to other commonly employed criteria using real and simulated data.

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Crossref · 10.1016/j.jim.2006.07.015

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  • With sera from individuals who had recovered from COVID-19, the fluorescent neutralization assay gave results comparable to the conventional plaque reduction neutralization assay.

    “With sera from patients who had recovered from COVID-19, the fluorescent neutralization assay produced comparable results to the conventional plaque reduction neutralization assay 43 .”

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Authors
Moodie, Z., Huang, Y., Gu, L., Hural, J., & Self, S. G.
Affiliations
Fred Hutch Cancer Center (US)
Corresponding author
Moodie, Zoe
Venue
Journal of Immunological Methods
Publisher
Elsevier BV
Published
2006-08
Volume
315
Issue
1-2
Pages
121-132
ISSN
0022-1759 (ISSN-L)
OpenAlex
W1980497671
Cited by
68
References
35
Citations by year
2026: 3 · 2025: 4 · 2024: 2 · 2023: 2 · 2022: 3 · 2021: 3 · 2020: 2 · 2018: 2 · 2017: 4 · 2016: 4 · 2015: 6 · 2014: 5 · 2013: 9 · 2012: 3
FWCI
0.69
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Immunological Methods (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health
  • National Institute of Allergy and Infectious Diseases (P30AI27757, R01-AI47086, R01 AI65328, U01 AI46725, U01AI046725, R37AI035605, P01 AI57005, R37AI35605, P01AI057005, R01AI065328, R01 AI48017, R01AI047086, P30AI027757)
Topics
  • Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Keywords
ELISPOT assay, HIV-1-specific T cell responses, effector T cells, false positive rate control
MeSH terms
Clinical Trials as Topic, Computer Simulation, Data Interpretation, Statistical, Enzyme-Linked Immunosorbent Assay, False Positive Reactions, HIV Seropositivity, Humans, Sensitivity and Specificity, T-Lymphocytes, HIV-1, AIDS Vaccines

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