Publication: Target product profile for a diagnostic assay to differentiate between bacterial and non-bacterial infections and reduce antimicrobial overuse in resource-limited settings: An expert consensus
Issued Date
2016-08-01
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ISSN
19326203
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2-s2.0-84991448099
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Mahidol University
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SCOPUS
Bibliographic Citation
PLoS ONE. Vol.11, No.8 (2016)
Suggested Citation
Sabine Dittrich, Birkneh Tilahun Tadesse, Francis Moussy, Arlene Chua, Anna Zorzet, Thomas Tängdén, David L. Dolinger, Anne Laure Page, John A. Crump, Valerie D'Acremont, Quique Bassat, Yoel Lubell, Paul N. Newton, Norbert Heinrich, Timothy J. Rodwell, Iveth J. González Target product profile for a diagnostic assay to differentiate between bacterial and non-bacterial infections and reduce antimicrobial overuse in resource-limited settings: An expert consensus. PLoS ONE. Vol.11, No.8 (2016). doi:10.1371/journal.pone.0161721 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/43199
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Title
Target product profile for a diagnostic assay to differentiate between bacterial and non-bacterial infections and reduce antimicrobial overuse in resource-limited settings: An expert consensus
Other Contributor(s)
Foundation for Innovative New Diagnostics, Switzerland
Organisation Mondiale de la Sante
Hawassa University
Tan Tock Seng Hospital
Uppsala Universitet
Epicentre
University of Otago
Duke University
Duke University Medical Center
Swiss Tropical and Public Health Institute (Swiss TPH)
Universitat Lausanne Schweiz
Instituto de Salud Global de Barcelona
Centro de Investigação em Saúde de Manhiça (CISM)
University of Oxford
Mahidol University
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)
Ludwig-Maximilians-Universität München
German Center for Cardiovascular Disease Research
Organisation Mondiale de la Sante
Hawassa University
Tan Tock Seng Hospital
Uppsala Universitet
Epicentre
University of Otago
Duke University
Duke University Medical Center
Swiss Tropical and Public Health Institute (Swiss TPH)
Universitat Lausanne Schweiz
Instituto de Salud Global de Barcelona
Centro de Investigação em Saúde de Manhiça (CISM)
University of Oxford
Mahidol University
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)
Ludwig-Maximilians-Universität München
German Center for Cardiovascular Disease Research
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.