Background: This study aims to address a critical gap in diagnostic testing capabilities across sub-Saharan Africa by developing a comprehensive decision tool designed to guide laboratories in selecting optimal diagnostic modalities, appropriate to their unique contexts, clinical needs, and available resources.
Methods:Evidence from a thematic framework analysis of stakeholder engagement from multiple African countries and global health institutions, and from a scoping review of grey literature on best practice for the design and selection of laboratory tests in resource poor-settings, was used to develop the decision tool in a decision tree format.
Findings: Stakeholder engagement revealed needs for enhanced data-sharing mechanisms, clear frameworks for diagnostic test selection and implementation, strengthened intra- and inter-country networking, and greater integration of user groups at both local and regional levels. The scoping review identified 39 records mapped to five themes, namely intended use, categories of test (underlying technology), laboratory capacity, commercial availability, and performance evaluation. The characteristics of three test modalities, specifically assay format, multiple analytes, and instruments were summarised based on three factors: cost (including cost of performance evaluation), diagnostic accuracy, and turnaround time. Findings informed the design of the decision tool into an intuitive framework, utilising a simple decision tree structure with visualisations to clearly illustrate the trade-offs between cost, accuracy, and turnaround time.
Interpretation: The decision tool enables stakeholders to make informed, context-specific decisions, contributing to expanding diagnostic readiness, local resilience and enhanced health outcomes across sub-Saharan Africa. The decision tool components are applicable worldwide.