Field validation of the performance of paper-based tests for the detection of the Zika and chikungunya viruses in serum samples.
Journal
Nature biomedical engineering
ISSN: 2157-846X
Titre abrégé: Nat Biomed Eng
Pays: England
ID NLM: 101696896
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
received:
25
03
2021
accepted:
24
01
2022
pubmed:
9
3
2022
medline:
12
4
2022
entrez:
8
3
2022
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 35256758
doi: 10.1038/s41551-022-00850-0
pii: 10.1038/s41551-022-00850-0
pmc: PMC8940623
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
246-256Subventions
Organisme : NIAID NIH HHS
ID : R21 AI136571
Pays : United States
Organisme : NIGMS NIH HHS
ID : DP2 GM126892
Pays : United States
Organisme : CIHR
ID : 201610FDN-375469
Pays : Canada
Organisme : CIHR
ID : 149783
Pays : Canada
Informations de copyright
© 2022. The Author(s).
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