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      Matching Development of Point-of-Care Diagnostic Tests to the Local Context: A Case Study of Visceral Leishmaniasis in Kenya and Uganda


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          We provide a new protocol to connect how findings from field research on the local health care setting in resource-limited regions can inform researchers that are working toward developing a new point-of-care diagnostic test for neglected tropical diseases.


          Key Findings

          • A concept target product profile is an effective new tool that can aid researchers to develop a technology to match specific health care context more quickly than a conventional target product profile.

          • The role of local volunteers and community health care workers is critically important for access to diagnostics in resource-limited settings.

          • A noninvasive test-of-cure and a screening and confirmation test will significantly improve management of visceral leishmaniasis in endemic regions.

          Key Implications

          • Early during the research and development stage, researchers should consider who will administer the test (patient, health care worker, doctor) and for what purpose.

          • Program managers should consider that the training level of staff and volunteers and the availability of the resources are the critical determinants for the use of a diagnostic test. 


          The rapid growth of point-of-care (POC) diagnostic tests necessitates a clear vision of when, where, and why a new POC diagnostic test needs to be developed and how it can be used in a way that matches a local health care context. Here, we present an innovative approach toward developing a concept target product profile (CTPP), which is a new mapping tool that helps researchers match a new diagnostic test to a specific local health care context early in the research and development process. As a case study, we focus on the diagnosis of visceral leishmaniasis (VL) in rural resource-limited regions of Kenya and Uganda. Our stepwise approach integrates elements of design thinking and uses a combination of literature reviews and field research for a context analysis of local health care systems and practices. We then use visual thinking in the form of Gigamaps and patient journeys to identify use case scenarios and to present our findings from the field research to key stakeholders. The use case scenarios describe the diagnostic scope of a new POC test based on the feasibility of the new test, the local need, and the contextual fit. For our case study of VL, we identify 2 valuable use case scenarios, namely test-of-cure and screening and confirmation, and we formulate a CTPP. We anticipate that a CTPP will enable researchers to match a new POC diagnostic test during the research and development process to the local health care context in which it will be used.

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          Most cited references29

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          CRISPR/Cas Systems towards Next-Generation Biosensing

          Beyond its remarkable genome editing ability, the CRISPR/Cas9 effector has also been utilized in biosensing applications. The recent discovery of the collateral RNA cleavage activity of the Cas13a effector has sparked even greater interest in developing novel biosensing technologies for nucleic acid detection and promised significant advances in CRISPR diagnostics. Now, along with the discovery of Cas12 collateral cleavage activities on single-stranded DNA (ssDNA), several CRISPR/Cas systems have been established for detecting various targets, including bacteria, viruses, cancer mutations, and others. Based on key Cas effectors, we provide a detailed classification of CRISPR/Cas biosensing systems and propose their future utility. As the field continues to mature, CRISPR/Cas systems have the potential to become promising candidates for next-generation diagnostic biosensing platforms.
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            Social and Economic Burden of Human Leishmaniasis.

            Leishmaniasis continues to pose a major public health problem worldwide. With new epidemics occurring in endemic areas and the spread of the disease to previously free areas because of migration, tourism, and military activities, there is a great need for the development of an effective vaccine. Leishmaniasis is a disease of the poor, occurring mostly in remote rural villages with poor housing and little or no access to modern health-care facilities. In endemic areas, diagnosis of any form of leishmaniasis puts a huge financial strain on an already meagre financial resource at both the individual and community levels. Most often families need to sell their assets (land and livestock) or take loans from informal financial outfits with heavy interest rates to pay for the diagnosis and treatment of leishmaniasis. Here, we discuss the disease with special emphasis on its socioeconomic impact on the affected individual and community. In addition, we highlight the reasons why continued research aimed at developing an effective Leishmania vaccine is necessary.
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              Point-of-care testing (POCT) and evidence-based laboratory medicine (EBLM) – does it leverage any advantage in clinical decision making?


                Author and article information

                Glob Health Sci Pract
                Glob Health Sci Pract
                Global Health: Science and Practice
                Global Health: Science and Practice
                1 October 2020
                1 October 2020
                : 8
                : 3
                : 549-565
                [a ]Department of Bionanoscience, Kavli Institute of Nanoscience Delft, Delft University of Technology , The Netherlands.
                [b ]Department of Sustainable Design Engineering, Section of Design for Sustainability, Faculty of Industrial Design Engineering, Delft University of Technology , The Netherlands.
                [c ]University of Nairobi , Kenya.
                [d ]Centre for Biotechnology Research and Development, Kenya Medical Research Institute , Kenya.
                Author notes

                Michel Bengtson and Mitasha Bharadwaj are co-first authors.

                Correspondence to Jan-Carel Diehl ( j.c.diehl@ 123456tudelft.nl ).
                © Bengtson et al.

                This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly cited. To view a copy of the license, visit http://creativecommons.org/licenses/by/4.0/. When linking to this article, please use the following permanent link: https://doi.org/10.9745/GHSP-D-20-00028

                : 13 January 2020
                : 11 August 2020
                Original Article


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