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Nat Biomed Eng ; 6(3): 246-256, 2022 03.
Article in English | MEDLINE | ID: mdl-35256758

ABSTRACT

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.


Subject(s)
Chikungunya Fever , Chikungunya virus , Dengue , Zika Virus Infection , Zika Virus , Chikungunya Fever/diagnosis , Chikungunya Fever/epidemiology , Dengue/diagnosis , Humans , Zika Virus/genetics , Zika Virus Infection/diagnosis , Zika Virus Infection/epidemiology
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