Mobile point-of-care molecular diagnostics for infectious diseases in extreme and resource-limited environments: a multi-phase operational and usability evaluation
File(s)
Author(s)
Type
Journal Article
Abstract
Background: The availability and reliability of molecular diagnostics in extreme, resource-limited environments is very restricted. We aimed to evaluate the operational feasibility, usability, and environmental robustness of a mobile point-of-care molecular diagnostic platform across a spectrum of challenging and extreme environments.
Methods: The Dragonfly platform (ProtonDx, UK) uses next-generation magnetic nanoparticle beads (TurboBeads) and SmartLid technology for extraction and purification of nucleic acids, coupled with lyophilised colourimetric loop-mediated isothermal amplification technology (lyoLAMP) to detect pathogens across a range of sample types. Using its multiplex Respiratory panel, whole system and component performance was assessed for robustness in non-laboratory settings (including cross-contamination, reliability, stability, mains power alternatives and usability) using Medicines Health Regulation Authority/Medical Device Coordination Group guidelines for diagnostic performance evaluation. User feedback was provided (Likert scale). Real-world usability was assessed in the remote High Arctic, at altitude >4000m, rural sub-tropical Africa, at sea in the North Atlantic. Non-laboratory performance was evaluated using clinical SARS-CoV-2 samples against real-time polymerase chain reaction and a clinical field test conducted in the context of military field training.
Findings: 435 clinical samples were tested in a non-laboratory setting, yielding 100% specificity (265/265, 95% CI 98.6-100) and 97.5% sensitivity (158/162, 95% CI 93.8-99.3). 365/368 additional (99.2%) tests of robustness returned positive results. Across 2400 observed actions, users made no hazardous errors. User feedback was positive (6.5/7, n=28 ease-of-use). During environmental testing, 40/40 (100%) whole system tests were positive across temperatures of -40 to +36oC and 130/130 (100%) positive using mains-alternative power sources. 86/90 (95.6%) clinical field tests matched paired PCR results.
Interpretation: The Dragonfly platform provided rapid, reliable and straight forward testing in a variety of austere environments, with potential to improve access in resource-limited, humanitarian or conflict settings. Such devices offer opportunity over adapted technologies which continue to have both distribution and suitability issues.
Methods: The Dragonfly platform (ProtonDx, UK) uses next-generation magnetic nanoparticle beads (TurboBeads) and SmartLid technology for extraction and purification of nucleic acids, coupled with lyophilised colourimetric loop-mediated isothermal amplification technology (lyoLAMP) to detect pathogens across a range of sample types. Using its multiplex Respiratory panel, whole system and component performance was assessed for robustness in non-laboratory settings (including cross-contamination, reliability, stability, mains power alternatives and usability) using Medicines Health Regulation Authority/Medical Device Coordination Group guidelines for diagnostic performance evaluation. User feedback was provided (Likert scale). Real-world usability was assessed in the remote High Arctic, at altitude >4000m, rural sub-tropical Africa, at sea in the North Atlantic. Non-laboratory performance was evaluated using clinical SARS-CoV-2 samples against real-time polymerase chain reaction and a clinical field test conducted in the context of military field training.
Findings: 435 clinical samples were tested in a non-laboratory setting, yielding 100% specificity (265/265, 95% CI 98.6-100) and 97.5% sensitivity (158/162, 95% CI 93.8-99.3). 365/368 additional (99.2%) tests of robustness returned positive results. Across 2400 observed actions, users made no hazardous errors. User feedback was positive (6.5/7, n=28 ease-of-use). During environmental testing, 40/40 (100%) whole system tests were positive across temperatures of -40 to +36oC and 130/130 (100%) positive using mains-alternative power sources. 86/90 (95.6%) clinical field tests matched paired PCR results.
Interpretation: The Dragonfly platform provided rapid, reliable and straight forward testing in a variety of austere environments, with potential to improve access in resource-limited, humanitarian or conflict settings. Such devices offer opportunity over adapted technologies which continue to have both distribution and suitability issues.
Date Acceptance
2026-08-11
Citation
The Lancet Microbe
ISSN
2666-5247
Publisher
Elsevier
Journal / Book Title
The Lancet Microbe
Copyright Statement
Subject to copyright. This paper is embargoed until publication. Once published the Version of Record (VoR) will be available on immediate open access.
Publication Status
Accepted