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
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

246-256

Subventions

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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Auteurs

Margot Karlikow (M)

Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
En Carta Diagnostics, Paris, France.

Severino Jefferson Ribeiro da Silva (SJR)

Department of Virology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil.

Yuxiu Guo (Y)

Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
LSK Technologies Inc, Kitchener, Ontario, Canada.

Seray Cicek (S)

Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
LSK Technologies Inc, Kitchener, Ontario, Canada.

Larissa Krokovsky (L)

Department of Entomology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil.

Paige Homme (P)

Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.

Yilin Xiong (Y)

Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.

Talia Xu (T)

Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.

Maria-Angelica Calderón-Peláez (MA)

Instituto de Virologia, Universidad El Bosque, Bogotá, Colombia.

Sigrid Camacho-Ortega (S)

Instituto de Virologia, Universidad El Bosque, Bogotá, Colombia.

Duo Ma (D)

Biodesign Center for Molecular Design and Biomimetics, The Biodesign Institute and the School of Molecular Sciences, Arizona State University, Tempe, AZ, USA.

Jurandy Júnior Ferraz de Magalhães (JJF)

Department of Virology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil.
Pernambuco State Central Laboratory (LACEN/PE), Department of Virology, Recife, Brazil.
University of Pernambuco (UPE), Serra Talhada Campus, Serra Talhada, Brazil.

Bárbara Nayane Rosário Fernandes Souza (BNRF)

Department of Virology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil.

Diego Guerra de Albuquerque Cabral (DG)

Department of Virology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil.
Pernambuco State Central Laboratory (LACEN/PE), Department of Virology, Recife, Brazil.

Katariina Jaenes (K)

Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.

Polina Sutyrina (P)

Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.

Tom Ferrante (T)

Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.

Andrea Denisse Benitez (AD)

Instituto Nacional de Investigación en Salud Pública 'Dr. Leopoldo Izquieta Pérez', Quito, Ecuador.

Victoria Nipaz (V)

Instituto Nacional de Investigación en Salud Pública 'Dr. Leopoldo Izquieta Pérez', Quito, Ecuador.

Patricio Ponce (P)

Instituto Nacional de Investigación en Salud Pública 'Dr. Leopoldo Izquieta Pérez', Quito, Ecuador.

Darius G Rackus (DG)

Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
Department of Chemistry and Biology, Ryerson University, Toronto, Ontario, Canada.
Institute for Biomedical Engineering Science and Technology (iBEST), a partnership between Ryerson University and St. Michael's Hospital Toronto, Toronto, Ontario, Canada.

James J Collins (JJ)

Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.
Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, MA, USA.
Institute for Medical Engineering and Science, MIT, Cambridge, MA, USA.
Synthetic Biology Center, MIT, Cambridge, MA, USA.
Harvard-MIT Program in Health Sciences and Technology, Cambridge, MA, USA.
Broad Institute of MIT and Harvard, Cambridge, MA, USA.

Marcelo Paiva (M)

Department of Entomology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil.

Jaime E Castellanos (JE)

Instituto de Virologia, Universidad El Bosque, Bogotá, Colombia.

Varsovia Cevallos (V)

Instituto Nacional de Investigación en Salud Pública 'Dr. Leopoldo Izquieta Pérez', Quito, Ecuador.

Alexander A Green (AA)

Department of Biomedical Engineering, Boston University, Boston, MA, USA.
Molecular Biology, Cell Biology & Biochemistry Program, Graduate School of Arts and Sciences, Boston University, Boston, MA, USA.
Biological Design Center, Boston University, Boston, MA, USA.

Constância Ayres (C)

Department of Entomology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil.

Lindomar Pena (L)

Department of Virology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil.

Keith Pardee (K)

Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada. keith.pardee@utoronto.ca.
Department of Mechanical and Industrial Engineering, University of Toronto, Toronto, Ontario, Canada. keith.pardee@utoronto.ca.

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