Abstract
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.
Highlights
Within the past decade, point-of-care (POC) diagnostic tests have received immense attention[1] because their accuracy and ease of use create the ideal solution for early diagnostics of infectious diseases in resource-limited settings
We propose to formulate a concept target product profile (CTPP) as an intermediate guideline for developing a diagnostic test that addresses the needs of the end users in the local health care context
We presented an approach that included design-thinking principles to formulate a CTPP that consists of multiple steps
Summary
Point-of-care (POC) diagnostic tests have received immense attention[1] because their accuracy and ease of use create the ideal solution for early diagnostics of infectious diseases in resource-limited settings. POC tests are designed to be performed near or at the site where the patient is to enable a short turnaround time for them to receive treatment and care.[2] Given these favorable characteristics, novel POC technologies for decentralized diagnostics are being developed worldwide at a rapid rate.[3] Ample research opportunities exist for continued development of POC diagnostic tests, for neglected tropical diseases (NTDs), which are a group of Matching Point-of-Care Diagnostic Tests to the Local Health Care Context www.ghspjournal.org chronic, disabling, and potentially fatal diseases that are prevalent in tropical and subtropical regions.[4].
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