Clinical validation trial of a diagnostic for Ebola Zaire antigen detection: Design rationale and challenges to implementation

Clinical Trials : Journal of the Society for Clinical Trials
John SchieffelinDonald S Grant

Abstract

The current Ebola outbreak in West Africa has affected more people than all previous outbreaks combined. The current diagnostic method of choice, quantitative polymerase chain reaction, requires specialized conditions as well as specially trained technicians. Insufficient testing capacity has extended the time from sample collection to results. These delays have led to further delays in the transfer and treatment to Ebola Treatment Units. A sensitive and specific point-of-care device that could be used reliably in low-resource settings by healthcare workers with minimal training would increase the efficiency of triage and appropriate transfer of care. This article describes a study designed to validate the sensitivity and specificity of the ReEBOVTM Rapid Diagnostic Test using venous whole blood and capillary blood obtained via fingerprick. We present the scientific and clinical rationale for the decisions made in the design of a diagnostic validation study to be conducted in an outbreak setting. The multi-site strategy greatly complicated implementation. In addition, a decrease in cases in one geographic area along with a concomitant increase in other areas made site selection challenging. Initiation of clinical trials during ...Continue Reading

References

Feb 5, 2008·Antiviral Research·Sheik Humarr KhanUNKNOWN Mano River Union Lassa Fever Network
Mar 22, 2014·PLoS Neglected Tropical Diseases·Jeffrey G ShafferUNKNOWN Viral Hemorrhagic Fever Consortium
Sep 23, 2014·The New England Journal of Medicine·UNKNOWN WHO Ebola Response TeamZabulon Yoti
Oct 30, 2014·The New England Journal of Medicine·John S SchieffelinUNKNOWN WHO Clinical Response Team
Dec 4, 2014·The Lancet Infectious Diseases·Ranu S DhillonGerardo Chowell
May 21, 2015·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Matthew K O'SheaEmma Hutley
Aug 8, 2015·The Lancet Infectious Diseases·Julie E Ledgerwood

❮ Previous
Next ❯

Citations

May 20, 2016·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Dietrich Haubenberger, David B Clifford
Aug 16, 2016·The Journal of Infectious Diseases·Matthew L BoisenRobert F Garry
Nov 28, 2017·Pharmaceutical Statistics·Abidemi K AdenijiAbdus S Wahed
Dec 14, 2018·Science Translational Medicine·David SebbaKristin Weidemaier

❮ Previous
Next ❯

Methods Mentioned

BETA
blood collection
PCR
blood draw

Software Mentioned

RealStar

Related Concepts

Related Feeds

Argentine Hemorrhagic Fever

Argentine hemorrhagic fever (AHF) is an endemo-epidemic disease caused by junín virus (JUNV), a member of the arenaviridae family. Discover the latest research on AHF here.

Related Papers

African Health Sciences
Beuy Joob, Viroj Wiwanitkit
The Lancet Infectious Diseases
The Lancet Infectious Diseases
The Lancet Global Health
Patricia J GarciaRosanna Peeling
Expert Review of Anti-infective Therapy
Jeshina JanardhananGeorge M Varghese
© 2022 Meta ULC. All rights reserved