JMIR Publications

ABSTRACT

Background:

Precision public health (PPH) can maximize impact by targeting surveillance and interventions to populations based on temporal, spatial, and epidemiological characteristics. Although the rapid diagnostic test (RDT) has enabled ubiquitous point-of-care testing in low-resource settings, its impact has been less than anticipated, due in part to lack of design features to streamline data capture and analysis.

Objective:

The goal of this work is to transform the RDT into a tool for PPH. This requires the definition of information and data axioms, an information utilization index (IUI), design features to maximize the IUI, and defining open guidelines (OG) for modular features of RDTs that enable links with digital health tools to create an RDT open guidelines (RDT-OG) system.

Methods:

A review of published articles, an assessment of current WHO prequalified RDTs, and a survey of thirty-three experts in RDT technology, manufacturing, and deployment were conducted to define design features and axioms for information utilization. An IUI was then calculated for WHO prequalified RDTs, and RDT-OG were formulated that maximize the IUI for RDTs. These guidelines were evaluated, in part, through their application to developing malaria and COVID-19 RDT-OG for use in Kenya and Indonesia.

Results:

The IUI of prequalified RDTs ranged from 13% to 75% with a median of 33%, in contrast to 91% for an optimized RDT-OG prototype. The RDT-OG system was shown to be feasible by: 1) creating a reference RDT-OG prototype, 2) implementing its features and capabilities on a smartphone RDT reader, cloud information system, and the Fast Healthcare Interoperability Resources (FHIR) and 3) analyzing the potential public health impact of RDT-OG integration with laboratory, surveillance, and vital statistics systems.

Conclusions:

Policymakers and manufacturers can define, adopt, and synergize with RDT-OG and digital health initiatives. The RDT-OG approach could enable real-time diagnostics and epidemiological monitoring with adaptive interventions to facilitate control or elimination of current and emerging diseases through PPH.