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

Abstract

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.

Abstract

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. 

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.