Use of the Filovirus Animal Non-Clinical Group (FANG) Ebola virus immuno-assay requires fewer study participants to power a study than the Alpha Diagnostic International assay

James Logue, Kaylie Tuznik, Dean Follmann, Greg Grandits, Jonathan Marchand, Cavan Reilly, Yeya dit Sadio Sarro, James Pettitt, Eric J. Stavale, Mosoka Fallah, Gene G. Olinger, Fatorma K. Bolay, Lisa E. Hensley

Research output: Contribution to journalArticlepeer-review

25 Scopus citations

Abstract

As part of the scientific community's development of medical countermeasures against Ebola virus disease, optimization of standardized assays for product evaluation is paramount. The recent outbreak heightened awareness to the scarcity of available assays and limited information on performance and reproducibility. To evaluate the immunogenicity of vaccines entering Phase I–III trials and to identify survivors, two enzyme-linked immunosorbent assays, the Filovirus Animal Non-Clinical Group assay and the Alpha Diagnostics International assay, were evaluated for detection of immunoglobulin G against Ebola virus glycoprotein. We found that the Filovirus Animal Nonclinical Group assay produced a wider range of relative antibody concentrations, higher assay precision, larger relative accuracy range, and lower regional background. Additionally, to sufficiently power a vaccine trial, use of the Filovirus Animal Nonclinical Group assay would require one third the number of participants than the Alpha Diagnostics International assay. This reduction in needed study participants will require less money, fewer man hours, and much less time to evaluate vaccine immunogenicity.

Original languageEnglish (US)
Pages (from-to)84-90
Number of pages7
JournalJournal of Virological Methods
Volume255
DOIs
StatePublished - May 2018
Externally publishedYes

Keywords

  • ADI
  • Antibodies
  • Ebola virus
  • ELISA
  • FANG
  • Immune response
  • Serology

ASJC Scopus subject areas

  • Virology

Fingerprint

Dive into the research topics of 'Use of the Filovirus Animal Non-Clinical Group (FANG) Ebola virus immuno-assay requires fewer study participants to power a study than the Alpha Diagnostic International assay'. Together they form a unique fingerprint.

Cite this