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Updated: Apr 18, 2026

Design to Implementation Study for Development and Patient Validation of Paper-Based Toehold Switch Diagnostics
Published on: June 17, 2022
Stakeholder engagement to identify barriers to implementation and inform the development of point-of-care diagnostics
I Salles1, E Lessem1, L Walshe2
1Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Background:
Rapid TB diagnosis is crucial for improving outcomes and reducing transmission, yet nearly one third of cases remain undiagnosed or unreported. Point-of-care (POC) diagnostics are critical for bridging this gap.
Methods:
We surveyed stakeholder priorities for TB POC diagnostics to inform development aligned with global needs. An online survey was disseminated through SMART4TB partner networks over 13 weeks. The survey captured preferences for diagnostic features, testing obstacles, and attributes to strengthen TB response. Ranked preferences were analysed using weighted scoring with subgroup comparisons.
Results:
Of 274 respondents, 89% were from high-burden countries and represented diverse stakeholders; 57% (155/274) were TB care providers. Accuracy and rapid turnaround time to results were top diagnostic features. Primary obstacles were external sample transport and consumables availability. Key attributes to effective TB response included sensitive POC tests, close follow-up, and more personnel training to recognise TB. Paediatric TB screening training was infrequent, with 53% rarely or never trained.
Conclusion:
Accuracy and rapid turnaround are priority attributes for new TB POC diagnostics. Overcoming systemic barriers, including robust systems for identifying those who need screening, sample transport, material availability, and care continuity, is critical to achieving the successful implementation, and full impact of POC diagnostics.
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