Field validation of the performance of paper-based tests for the detection of the Zika and chikungunya viruses in serum samples

Autor: Margot Karlikow, Severino Jefferson Ribeiro da Silva, Yuxiu Guo, Seray Cicek, Larissa Krokovsky, Paige Homme, Yilin Xiong, Talia Xu, Maria-Angelica Calderón-Peláez, Sigrid Camacho-Ortega, Duo Ma, Jurandy Júnior Ferraz de Magalhães, Bárbara Nayane Rosário Fernandes Souza, Diego Guerra de Albuquerque Cabral, Katariina Jaenes, Polina Sutyrina, Tom Ferrante, Andrea Denisse Benitez, Victoria Nipaz, Patricio Ponce, Darius G. Rackus, James J. Collins, Marcelo Paiva, Jaime E. Castellanos, Varsovia Cevallos, Alexander A. Green, Constância Ayres, Lindomar Pena, Keith Pardee
Rok vydání: 2022
Předmět:
Zdroj: Nature Biomedical Engineering. 6:246-256
ISSN: 2157-846X
DOI: 10.1038/s41551-022-00850-0
Popis: 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.
Databáze: OpenAIRE
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