REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes

Abstract

Lack of access to quality diagnostics remains a major contributor to health burden in resource-limited settings. It has been more than 10 years since ASSURED (affordable, sensitive, specific, user-friendly, rapid, equipment-free, delivered) was coined to describe the ideal test to meet the needs of the developing world. Since its initial publication, technological innovations have led to the development of diagnostics that address the ASSURED criteria, but challenges remain. From this perspective, we assess factors contributing to the success and failure of ASSURED diagnostics, lessons learnt in the implementation of ASSURED tests over the past decade, and highlight additional conditions that should be considered in addressing point-of-care needs. With rapid advances in digital technology and mobile health (m-health), future diagnostics should incorporate these elements to give us REASSURED diagnostic systems that can inform disease control strategies in real-time, strengthen the efficiency of health care systems and improve patient outcomes.

Fig. 1. Test trade-offs at different levels of the health care system.

a, Schematic showing the different levels of health care available from national to community levels, indicating the equipment and tests which are available at each level. Lab-NAT: laboratory-based nucleic acid tests; EIA, enzyme immunoassay; WB, western blot; CLIA, chemiluminescence immunoassay; ECL, electrochemiluminescence immunoassay. b, Key characteristics of diagnostics tests to reflect trade-offs between accuracy, accessibility and affordability for different levels of the health care system. Panel a adapted from ref. , WHO.

Fig. 2. Schematic showing different technical components that could combine to form the ideal diagnostic test.

Components from existing laboratory equipment-based tests, standard lateral flow diagnostic tests, and new technologies such as synthetic biology and printed components, would be combined to create new diagnostic tests. S. Smith, CSIR.