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

Nat Biomed Eng. 2022 Mar;6(3):246-256. doi: 10.1038/s41551-022-00850-0. Epub 2022 Mar 7.

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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Chikungunya Fever* / diagnosis
  • Chikungunya Fever* / epidemiology
  • Chikungunya virus*
  • Dengue* / diagnosis
  • Humans
  • Zika Virus Infection* / diagnosis
  • Zika Virus Infection* / epidemiology
  • Zika Virus* / genetics