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

Fecha de publicación: 01/01/2022 Fecha Ahead of Print: 01/03/2022

Autores organización

Maria Angelica Calderon Pelaez

Autor
Jaime Eduardo Castellanos Parra

Autor

Autores

Karlikow M
da Silva SJR
Guo Y
Cicek S
Krokovsky L
Homme P
Xiong Y
Xu T
Camacho-Ortega S
Ma D
de Magalhães JJF
Souza BNRF
de Albuquerque Cabral DG
Jaenes K
Sutyrina P
Ferrante T
Benitez AD
Nipaz V
Ponce P
Rackus DG
Collins JJ
Paiva M
Cevallos V
Green AA
Ayres C
Pena L
Pardee K

Grupos de investigación

Grupo de Virología

Investigador

Jaime Eduardo Castellanos Parra

Resumen

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. © 2022, The Author(s).

Datos de la publicación

ISSN/ISSNe:: 2157-846X, 2157-846X
Tipo:: Article
Páginas:: 246-256
DOI:: 10.1038/s41551-022-00850-0
Enlace a otro recurso:: www.scopus.com

Documentos

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Métricas

Filiaciones

Karlikow M:: Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada

En Carta Diagnostics, Paris, France
da Silva SJR:: Department of Virology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil
Guo Y:: Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada

LSK Technologies Inc, Kitchener, ON, Canada
Cicek S:: Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada

LSK Technologies Inc, Kitchener, ON, Canada
Krokovsky L:: Department of Entomology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil
Homme P:: Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada
Xiong Y:: Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada
Xu T:: Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada
Calderón-Peláez M.-A.:: Universidad. Instituto de Virologia, Universidad El Bosque, Bogotá, Colombia
Camacho-Ortega S:: Universidad. Instituto de Virologia, Universidad El Bosque, Bogotá, Colombia
Ma D:: Biodesign Center for Molecular Design and Biomimetics, The Biodesign Institute and the School of Molecular Sciences, Arizona State University, Tempe, AZ, United States
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
Souza BNRF:: Department of Virology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil
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
Jaenes K:: Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada
Sutyrina P:: Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada
Ferrante T:: Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, United States
Benitez AD:: Instituto Nacional de Investigación en Salud Pública ‘Dr. Leopoldo Izquieta Pérez’, Quito, Ecuador
Nipaz V:: Instituto Nacional de Investigación en Salud Pública ‘Dr. Leopoldo Izquieta Pérez’, Quito, Ecuador
Ponce P:: Instituto Nacional de Investigación en Salud Pública ‘Dr. Leopoldo Izquieta Pérez’, Quito, Ecuador
Rackus DG:: Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada

Department of Chemistry and Biology, Ryerson University, Toronto, ON, Canada

Institute for Biomedical Engineering Science and Technology (iBEST), a partnership between Ryerson University and St. Michael’s Hospital Toronto, Toronto, ON, Canada
Collins JJ:: Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, United States

Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, MA, United States

Institute for Medical Engineering and Science, MIT, Cambridge, MA, United States

Synthetic Biology Center, MIT, Cambridge, MA, United States

Harvard-MIT Program in Health Sciences and Technology, Cambridge, MA, United States

Broad Institute of MIT and Harvard, Cambridge, MA, United States
Paiva M:: Department of Entomology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil
Castellanos JE:: Universidad. Instituto de Virologia, Universidad El Bosque, Bogotá, Colombia
Cevallos V:: Instituto Nacional de Investigación en Salud Pública ‘Dr. Leopoldo Izquieta Pérez’, Quito, Ecuador
Green AA:: Department of Biomedical Engineering, Boston University, Boston, MA, United States

Molecular Biology, Cell Biology & Biochemistry Program, Graduate School of Arts and Sciences, Boston University, Boston, MA, United States

Biological Design Center, Boston University, Boston, MA, United States
Ayres C:: Department of Entomology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil
Pena L:: Department of Virology, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil
Pardee K:: Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada

Department of Mechanical and Industrial Engineering, University of Toronto, Toronto, ON, Canada

Keywords

Chikungunya Fever; Chikungunya virus; Dengue; Humans; Zika Virus; Zika Virus Infection; Polymerase chain reaction; Software testing; Synthetic biology; Testing; Chikungunya; Confidence interval; Diagnostic tests; Field validation; Infectious disease outbreaks; Latin America; Low-resource settings; Paper-based test; Performance; Serum samples; Article; Chikungunya virus; controlled study; Dengue virus; human; human cell; isothermal amplification; nonhuman; real time polymerase chain reaction; South and Central America; validation process; virus detection; Yellow fever virus; Zika virus; chikungunya; dengue; genetics; Zika fever; Diagnosis