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.

Autor: Logue J; Integrated Research Facility at Frederick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick MD, USA. Electronic address: james.logue@nih.gov., Tuznik K; Integrated Research Facility at Frederick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick MD, USA., Follmann D; Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Grandits G; University of Minnesota, School of Public Health, Division of Biostatistics, Minneapolis, MN, USA., Marchand J; Integrated Research Facility at Frederick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick MD, USA., Reilly C; University of Minnesota, School of Public Health, Division of Biostatistics, Minneapolis, MN, USA., Sarro YDS; University Clinical Research Center (UCRC) - SEREFO Laboratory, University of Sciences, Techniques and Technology of Bamako (USTTB), Bamako, Mali., Pettitt J; Integrated Research Facility at Frederick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick MD, USA., Stavale EJ; Integrated Research Facility at Frederick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick MD, USA., Fallah M; Ministry of Health, Monrovia, Liberia., Olinger GG; Integrated Research Facility at Frederick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick MD, USA., Bolay FK; Ministry of Health, Monrovia, Liberia., Hensley LE; Integrated Research Facility at Frederick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick MD, USA.
Jazyk: angličtina
Zdroj: Journal of virological methods [J Virol Methods] 2018 May; Vol. 255, pp. 84-90. Date of Electronic Publication: 2018 Feb 23.
DOI: 10.1016/j.jviromet.2018.02.018
Abstrakt: 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.
(Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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