Evaluating the Clinical, Economic, and Societal Value of Rapid Diagnostic Testing in Emerging Markets: A Systematic Literature Review Assessing Infectious Diseases

OBJECTIVES: Point of care rapid diagnostic tests (RDTs) have demonstrated accurate and timely diagnosis across decentralized settings, broadening patient access in remote locations and improving pathways to diagnosis. This study aimed to synthesize published and other literature on the clinical, societal, and economic value of RDTs for infectious disease across Asia, Africa, and Latin America.

METHODS: A systematic literature review (SLR) was conducted using PubMed and Embase for publications dated 2017 to 2021 in accordance with PRISMA guidelines using RDT and infectious disease search terms. This SLR was supplemented by targeted searches to evaluate guidelines and recommendations for RDTs from non-governmental organizations or other bodies (e.g. WHO).

RESULTS: Of the 616 articles identified in the systematic search, 128 were selected for full-text review, and 63 were included across the targeted and systematic review. Studies spanned 28 countries and 6 infectious diseases. Outcomes were clinical (e.g., patient outcomes), societal (e.g., reduced patient/clinician burden), and economic (e.g., cost savings). Of the 15 studies that reported RDT time to results, 10 reported results in under 1 hour which can lead to testing/treating more patients. Five studies showed that RDTs led to faster time to treatment for multiple disease areas compared to treatment initiated based on centralized laboratory testing, which can reduce the spread of infectious diseases. RDTs can reduce clinical and economic costs for misdiagnosis by reducing unnecessary treatment, including antibiotics that lead to resistance in select populations. Additionally, 11 studies reported high RDT usability for patients and/or clinicians.

CONCLUSIONS: Point of care RDTs with high demonstrated accuracy provide for timely and cost-effective diagnosis across decentralized settings, even in remote areas of emerging markets. This allows for quicker treatment and can improve clinical outcomes. Further work is needed to translate existing evidence into population-level studies/models to determine the holistic impact of RDT implementation.