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Diagnostics 2019, 9(1), 10; https://doi.org/10.3390/diagnostics9010010

Defining System Requirements for Simplified Blood Culture to Enable Widespread Use in Resource-Limited Settings

1
Foundation for Innovative New Diagnostics (FIND), Malaria and Fever Program, Chemine des Mines 9, Geneva 1202, Switzerland
2
Division of Infectious Disease & Vaccinology, School of Public Health, University of California, Berkeley 94720, CA, USA
3
Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford OX1 3SY, UK
4
Myanmar Oxford Clinical Research Unit, Yangon, Myanmar
5
Department of Pathology, Stanford University, Palo Alto 94304, CA, USA
6
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR
7
Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK
8
Pole of Clinical Research, French Institute of Health and Medical Research, Paris 75013, France
9
Department of Epidemiology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg 20359, Germany
10
Kinshasa Mahidol Oxford Research Unit, University of Oxford and Kinshasa School of Public Health, Kinshasa, The Democratic Republic of Congo
11
Division of Infectious Diseases, Department of Medicine, School of Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA
12
National Health Laboratory, Gaborone, Botswana
13
Department of Medical Microbiology, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Received: 15 October 2018 / Revised: 20 December 2018 / Accepted: 26 December 2018 / Published: 11 January 2019
(This article belongs to the Special Issue Diagnosis of Bacterial Pathogens)
Full-Text   |   PDF [221 KB, uploaded 11 January 2019]

Abstract

Bacterial blood stream infections (BSI) are a common cause of mortality and morbidity globally. As the causative agents and the resulting treatment decisions vary, near-patient testing and surveillance tools are necessary to monitor bacterial causes and resistance to antimicrobial agents. The gold standard to identify BSIs is blood culture (BC), a methodology not widely available in resource-limited settings. The aim of the study was to map out a target product profile of a simplified BC system (SBCS) to inform product development efforts. To identify the desired characteristics of a SBCS, we enlisted a small group of specialists working in Africa and Asia. Questions were used to understand challenges and how these constraints inform system requirements. The specialists were infectious disease physicians, public health/clinical microbiologists, clinical researchers, and technology experts with different geographical backgrounds. All suggested that BC should ideally be available at the district hospital level. Many of the same operational challenges, such as limited availability of culture bottles, electricity and internet connectivity, profuse dust, the lack of ambient temperature control, and human capacity constraints were identified across the different regions. BCs, although the accepted gold standard for diagnosis of BSIs, are not widely available outside of reference/research centers in Africa and Asia. To extend the reach of this important tool, it is crucial to engage product developers and academic research partners to develop accessible alternatives. View Full-Text
Keywords: blood culture; hemoculture; target product profile; low- and middle-income countries; LMICs; resource limited; microbiology; AMR; sepsis blood culture; hemoculture; target product profile; low- and middle-income countries; LMICs; resource limited; microbiology; AMR; sepsis
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

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Dailey, P.J.; Osborn, J.; Ashley, E.A.; Baron, E.J.; Dance, D.A.B.; Fusco, D.; Fanello, C.; Manabe, Y.C.; Mokomane, M.; Newton, P.N.; Tessema, B.; Isaacs, C.; Dittrich, S. Defining System Requirements for Simplified Blood Culture to Enable Widespread Use in Resource-Limited Settings. Diagnostics 2019, 9, 10.

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