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dc.contributor.authorSabine Dittrichen_US
dc.contributor.authorBirkneh Tilahun Tadesseen_US
dc.contributor.authorFrancis Moussyen_US
dc.contributor.authorArlene Chuaen_US
dc.contributor.authorAnna Zorzeten_US
dc.contributor.authorThomas Tängdénen_US
dc.contributor.authorDavid L. Dolingeren_US
dc.contributor.authorAnne Laure Pageen_US
dc.contributor.authorJohn A. Crumpen_US
dc.contributor.authorValerie D'Acremonten_US
dc.contributor.authorQuique Bassaten_US
dc.contributor.authorYoel Lubellen_US
dc.contributor.authorPaul N. Newtonen_US
dc.contributor.authorNorbert Heinrichen_US
dc.contributor.authorTimothy J. Rodwellen_US
dc.contributor.authorIveth J. Gonzálezen_US
dc.contributor.otherFoundation for Innovative New Diagnostics, Switzerlanden_US
dc.contributor.otherOrganisation Mondiale de la Santeen_US
dc.contributor.otherHawassa Universityen_US
dc.contributor.otherTan Tock Seng Hospitalen_US
dc.contributor.otherUppsala Universiteten_US
dc.contributor.otherUniversity of Otagoen_US
dc.contributor.otherDuke Universityen_US
dc.contributor.otherDuke University Medical Centeren_US
dc.contributor.otherSwiss Tropical and Public Health Institute (Swiss TPH)en_US
dc.contributor.otherUniversitat Lausanne Schweizen_US
dc.contributor.otherInstituto de Salud Global de Barcelonaen_US
dc.contributor.otherCentro de Investigação em Saúde de Manhiça (CISM)en_US
dc.contributor.otherUniversity of Oxforden_US
dc.contributor.otherMahidol Universityen_US
dc.contributor.otherLao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)en_US
dc.contributor.otherLudwig-Maximilians-Universität Münchenen_US
dc.contributor.otherGerman Center for Cardiovascular Disease Researchen_US
dc.identifier.citationPLoS ONE. Vol.11, No.8 (2016)en_US
dc.description.abstract© 2016 Dittrich et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Acute fever is one of the most common presenting symptoms globally. In order to reduce the empiric use of antimicrobial drugs and improve outcomes, it is essential to improve diagnostic capabilities. In the absence of microbiology facilities in low-income settings, an assay to distinguish bacterial from non-bacterial causes would be a critical first step. To ensure that patient and market needs are met, the requirements of such a test should be specified in a target product profile (TPP). To identify minimal/optimal characteristics for a bacterial vs. non-bacterial fever test, experts from academia and international organizations with expertise in infectious diseases, diagnostic test development, laboratory medicine, global health, and health economics were convened. Proposed TPPs were reviewed by this working group, and consensus characteristics were defined. The working group defined non-severely ill, non-malaria infected children as the target population for the desired assay. To provide access to the most patients, the test should be deployable to community health centers and informal health settings, and staff should require <2 days of training to perform the assay. Further, given that the aim is to reduce inappropriate antimicrobial use as well as to deliver appropriate treatment for patients with bacterial infections, the group agreed on minimal diagnostic performance requirements of >90% and >80% for sensitivity and specificity, respectively. Other key characteristics, to account for the challenging environment at which the test is targeted, included: i) time-to-result <10 min (but maximally <2 hrs); ii) storage conditions at 0-40°C, ≤90% non-condensing humidity with a minimal shelf life of 12 months; iii) operational conditions of 5-40°C, ≤90% non-condensing humidity; and iv) minimal sample collection needs (50-100μL, capillary blood). This expert approach to define assay requirements for a bacterial vs. non-bacterial assay should guide product development, and enable targeted and timely efforts by industry partners and academic institutions.en_US
dc.rightsMahidol Universityen_US
dc.subjectAgricultural and Biological Sciencesen_US
dc.subjectBiochemistry, Genetics and Molecular Biologyen_US
dc.titleTarget product profile for a diagnostic assay to differentiate between bacterial and non-bacterial infections and reduce antimicrobial overuse in resource-limited settings: An expert consensusen_US
Appears in Collections:Scopus 2016-2017

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