期刊
NATURE BIOMEDICAL ENGINEERING
卷 6, 期 3, 页码 246-+出版社
NATURE PORTFOLIO
DOI: 10.1038/s41551-022-00850-0
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资金
- Precision Medicine Initiative (PRiME) at the University of Toronto [PRMF2019-002]
- Foundation for Science and Technology of Pernambuco-Brazil [IBPG-1321-2.12/18]
- CIHR Foundation [201610FDN-375469]
- Canada Research Chairs Program [950-231075, 950-233107]
- University of Toronto's Major Research Project Management Fund
- University of Toronto's Connaught New Researcher Award
- CIHR/IDRC Team Grant: Canada-Latin America-Caribbean Zika Virus Program [FRN: 149783]
- NIH [1DP2GM126892, 1R21AI136571-01A1]
- Bill & Melinda Gates Foundation [OPP1160667]
- Arizona Biomedical Research Commission New Investigator Award [ADHS16-162400]
- Alfred P. Sloan Fellowship [FG-2017-9108]
- Bill and Melinda Gates Foundation [OPP1160667] Funding Source: Bill and Melinda Gates Foundation
Paper-based diagnostic tests combined with a portable device perform well for the diagnosis of Zika and chikungunya viruses in low-resource settings, as shown by double-blinded studies.
In low-resource settings, resilience to infectious disease outbreaks can be hindered by limited access to diagnostic tests. Here we report the results of double-blinded studies of the performance of paper-based diagnostic tests for the Zika and chikungunya viruses in a field setting in Latin America. The tests involved a cell-free expression system relying on isothermal amplification and toehold-switch reactions, a purpose-built portable reader and onboard software for computer vision-enabled image analysis. In patients suspected of infection, the accuracies and sensitivities of the tests for the Zika and chikungunya viruses were, respectively, 98.5% (95% confidence interval, 96.2-99.6%, 268 serum samples) and 98.5% (95% confidence interval, 91.7-100%, 65 serum samples) and approximately 2 aM and 5 fM (both concentrations are within clinically relevant ranges). The analytical specificities and sensitivities of the tests for cultured samples of the viruses were equivalent to those of the real-time quantitative PCR. Cell-free synthetic biology tools and companion hardware can provide de-centralized, high-capacity and low-cost diagnostics for use in low-resource settings. Double-blinded studies show that paper-based diagnostic tests and a companion portable device designed for use in low-resource settings perform well for the diagnosis of the Zika and chikungunya viruses in serum samples.
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