Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept study

Autores
Rojas Panozo, Lizeth; Rivera Nina, Silvia; Wehrendt, Diana Patricia; Casellas, Aina; Pinto, Lilian; Mendez, Susana; Kuo, Chi Wei; Lozano, Daniel F.; Ortiz, Lourdes; Pinazo, Maria Jesus; Picado, Albert; Sanz, Sergi; Abril, Marcelo; Gascon, Joaquim; Wong, Season; Schijman, Alejandro Gabriel; Torrico, Faustino; Alonso Padilla, Julio
Año de publicación
2024
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Vertical transmission of Trypanosoma cruzi represents approximately 20% of new Chagas disease cases. Early detection and treatment for women of childbearing age and newborns is a public health priority, but the lack of a simple and reliable diagnostic test remains a major barrier. We aimed to evaluate the performance of a point-of-care loop-mediated isothermal amplification (LAMP) assay for the detection of T cruzi. In this proof-of-concept study, we coupled a low-cost 3D printer repurposed for sample preparation and amplification (PrintrLab) to the Eiken T cruzi-LAMP prototype to detect vertically transmitted T cruzi, which we compared with standardised PCR and with the gold-standard algorithm (microscopy at birth and 2 months and serological study several months later). We screened pregnant women from two hospitals in the Bolivian Gran Chaco province, and those who were seropositive for T cruzi were offered the opportunity for their newborns to be enrolled in the study. Newborns were tested by microscopy, LAMP, and PCR at birth and 2 months, and by serology at 8 months.Between April 23 and Nov 17, 2018, 986 mothers were screened, among whom 276 were seropositive for T cruzi (28·0% prevalence, 95% CI 25·6-31·2). In total, 224 infants born to 221 seropositive mothers completed 8 months of follow-up. Congenital transmission was detected in nine of the 224 newborns (4·0% prevalence, 1·9-7·5) by direct microscopy observation, and 14 more cases were diagnosed serologically (6·3%, 3·6-10·3), accounting for an overall vertical transmission rate of 10·3% (6·6-15·0; 23 of 224). All microscopy-positive newborns were positive by PrintrLab-LAMP and by PCR, while these techniques respectively detected four and five extra positive cases among the remaining 215 microscopy-negative newborns. The PrintrLab-LAMP yielded a higher sensitivity than microscopy-based analysis. Considering the simpler use and expected lower cost of LAMP compared with PCR, our findings encourage its evaluation in a larger study over a wider geographical area.
Fil: Rojas Panozo, Lizeth. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; Bolivia
Fil: Rivera Nina, Silvia. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; Bolivia
Fil: Wehrendt, Diana Patricia. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
Fil: Casellas, Aina. Universidad de Barcelona; España
Fil: Pinto, Lilian. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; Bolivia
Fil: Mendez, Susana. Universidad de Barcelona; España
Fil: Kuo, Chi Wei. Ai Biosciences, Inc.; Estados Unidos
Fil: Lozano, Daniel F.. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; Bolivia
Fil: Ortiz, Lourdes. Universidad Autónoma Juan Misael Saracho.; Bolivia
Fil: Pinazo, Maria Jesus. Drugs for Neglected Diseases Initiative; Brasil
Fil: Picado, Albert. Foundation For Innovative New Diagnostics; Suiza
Fil: Sanz, Sergi. Universidad de Barcelona; España
Fil: Abril, Marcelo. Fundación Mundo Sano; Argentina
Fil: Gascon, Joaquim. Universidad de Barcelona; España
Fil: Wong, Season. Ai Biosciences, Inc.; Estados Unidos
Fil: Schijman, Alejandro Gabriel. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
Fil: Torrico, Faustino. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; Bolivia
Fil: Alonso Padilla, Julio. Universidad de Barcelona; España
Materia
CHAGAS DISEASE
VERTICAL TRANSMISSION
REPURPOSED 3D PRINTER
LAMP
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/246113

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network_name_str CONICET Digital (CONICET)
spelling Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept studyRojas Panozo, LizethRivera Nina, SilviaWehrendt, Diana PatriciaCasellas, AinaPinto, LilianMendez, SusanaKuo, Chi WeiLozano, Daniel F.Ortiz, LourdesPinazo, Maria JesusPicado, AlbertSanz, SergiAbril, MarceloGascon, JoaquimWong, SeasonSchijman, Alejandro GabrielTorrico, FaustinoAlonso Padilla, JulioCHAGAS DISEASEVERTICAL TRANSMISSIONREPURPOSED 3D PRINTERLAMPhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Vertical transmission of Trypanosoma cruzi represents approximately 20% of new Chagas disease cases. Early detection and treatment for women of childbearing age and newborns is a public health priority, but the lack of a simple and reliable diagnostic test remains a major barrier. We aimed to evaluate the performance of a point-of-care loop-mediated isothermal amplification (LAMP) assay for the detection of T cruzi. In this proof-of-concept study, we coupled a low-cost 3D printer repurposed for sample preparation and amplification (PrintrLab) to the Eiken T cruzi-LAMP prototype to detect vertically transmitted T cruzi, which we compared with standardised PCR and with the gold-standard algorithm (microscopy at birth and 2 months and serological study several months later). We screened pregnant women from two hospitals in the Bolivian Gran Chaco province, and those who were seropositive for T cruzi were offered the opportunity for their newborns to be enrolled in the study. Newborns were tested by microscopy, LAMP, and PCR at birth and 2 months, and by serology at 8 months.Between April 23 and Nov 17, 2018, 986 mothers were screened, among whom 276 were seropositive for T cruzi (28·0% prevalence, 95% CI 25·6-31·2). In total, 224 infants born to 221 seropositive mothers completed 8 months of follow-up. Congenital transmission was detected in nine of the 224 newborns (4·0% prevalence, 1·9-7·5) by direct microscopy observation, and 14 more cases were diagnosed serologically (6·3%, 3·6-10·3), accounting for an overall vertical transmission rate of 10·3% (6·6-15·0; 23 of 224). All microscopy-positive newborns were positive by PrintrLab-LAMP and by PCR, while these techniques respectively detected four and five extra positive cases among the remaining 215 microscopy-negative newborns. The PrintrLab-LAMP yielded a higher sensitivity than microscopy-based analysis. Considering the simpler use and expected lower cost of LAMP compared with PCR, our findings encourage its evaluation in a larger study over a wider geographical area.Fil: Rojas Panozo, Lizeth. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; BoliviaFil: Rivera Nina, Silvia. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; BoliviaFil: Wehrendt, Diana Patricia. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; ArgentinaFil: Casellas, Aina. Universidad de Barcelona; EspañaFil: Pinto, Lilian. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; BoliviaFil: Mendez, Susana. Universidad de Barcelona; EspañaFil: Kuo, Chi Wei. Ai Biosciences, Inc.; Estados UnidosFil: Lozano, Daniel F.. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; BoliviaFil: Ortiz, Lourdes. Universidad Autónoma Juan Misael Saracho.; BoliviaFil: Pinazo, Maria Jesus. Drugs for Neglected Diseases Initiative; BrasilFil: Picado, Albert. Foundation For Innovative New Diagnostics; SuizaFil: Sanz, Sergi. Universidad de Barcelona; EspañaFil: Abril, Marcelo. Fundación Mundo Sano; ArgentinaFil: Gascon, Joaquim. Universidad de Barcelona; EspañaFil: Wong, Season. Ai Biosciences, Inc.; Estados UnidosFil: Schijman, Alejandro Gabriel. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; ArgentinaFil: Torrico, Faustino. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; BoliviaFil: Alonso Padilla, Julio. Universidad de Barcelona; EspañaElsevier2024-09info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/246113Rojas Panozo, Lizeth; Rivera Nina, Silvia; Wehrendt, Diana Patricia; Casellas, Aina; Pinto, Lilian; et al.; Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept study; Elsevier; The Lancet Microbe; 5; 9; 9-2024; 1-82666-5247CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S2666524724001101info:eu-repo/semantics/altIdentifier/doi/10.1016/S2666-5247(24)00110-1info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-12-03T09:12:59Zoai:ri.conicet.gov.ar:11336/246113instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-12-03 09:12:59.395CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept study
title Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept study
spellingShingle Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept study
Rojas Panozo, Lizeth
CHAGAS DISEASE
VERTICAL TRANSMISSION
REPURPOSED 3D PRINTER
LAMP
title_short Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept study
title_full Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept study
title_fullStr Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept study
title_full_unstemmed Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept study
title_sort Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept study
dc.creator.none.fl_str_mv Rojas Panozo, Lizeth
Rivera Nina, Silvia
Wehrendt, Diana Patricia
Casellas, Aina
Pinto, Lilian
Mendez, Susana
Kuo, Chi Wei
Lozano, Daniel F.
Ortiz, Lourdes
Pinazo, Maria Jesus
Picado, Albert
Sanz, Sergi
Abril, Marcelo
Gascon, Joaquim
Wong, Season
Schijman, Alejandro Gabriel
Torrico, Faustino
Alonso Padilla, Julio
author Rojas Panozo, Lizeth
author_facet Rojas Panozo, Lizeth
Rivera Nina, Silvia
Wehrendt, Diana Patricia
Casellas, Aina
Pinto, Lilian
Mendez, Susana
Kuo, Chi Wei
Lozano, Daniel F.
Ortiz, Lourdes
Pinazo, Maria Jesus
Picado, Albert
Sanz, Sergi
Abril, Marcelo
Gascon, Joaquim
Wong, Season
Schijman, Alejandro Gabriel
Torrico, Faustino
Alonso Padilla, Julio
author_role author
author2 Rivera Nina, Silvia
Wehrendt, Diana Patricia
Casellas, Aina
Pinto, Lilian
Mendez, Susana
Kuo, Chi Wei
Lozano, Daniel F.
Ortiz, Lourdes
Pinazo, Maria Jesus
Picado, Albert
Sanz, Sergi
Abril, Marcelo
Gascon, Joaquim
Wong, Season
Schijman, Alejandro Gabriel
Torrico, Faustino
Alonso Padilla, Julio
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv CHAGAS DISEASE
VERTICAL TRANSMISSION
REPURPOSED 3D PRINTER
LAMP
topic CHAGAS DISEASE
VERTICAL TRANSMISSION
REPURPOSED 3D PRINTER
LAMP
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Vertical transmission of Trypanosoma cruzi represents approximately 20% of new Chagas disease cases. Early detection and treatment for women of childbearing age and newborns is a public health priority, but the lack of a simple and reliable diagnostic test remains a major barrier. We aimed to evaluate the performance of a point-of-care loop-mediated isothermal amplification (LAMP) assay for the detection of T cruzi. In this proof-of-concept study, we coupled a low-cost 3D printer repurposed for sample preparation and amplification (PrintrLab) to the Eiken T cruzi-LAMP prototype to detect vertically transmitted T cruzi, which we compared with standardised PCR and with the gold-standard algorithm (microscopy at birth and 2 months and serological study several months later). We screened pregnant women from two hospitals in the Bolivian Gran Chaco province, and those who were seropositive for T cruzi were offered the opportunity for their newborns to be enrolled in the study. Newborns were tested by microscopy, LAMP, and PCR at birth and 2 months, and by serology at 8 months.Between April 23 and Nov 17, 2018, 986 mothers were screened, among whom 276 were seropositive for T cruzi (28·0% prevalence, 95% CI 25·6-31·2). In total, 224 infants born to 221 seropositive mothers completed 8 months of follow-up. Congenital transmission was detected in nine of the 224 newborns (4·0% prevalence, 1·9-7·5) by direct microscopy observation, and 14 more cases were diagnosed serologically (6·3%, 3·6-10·3), accounting for an overall vertical transmission rate of 10·3% (6·6-15·0; 23 of 224). All microscopy-positive newborns were positive by PrintrLab-LAMP and by PCR, while these techniques respectively detected four and five extra positive cases among the remaining 215 microscopy-negative newborns. The PrintrLab-LAMP yielded a higher sensitivity than microscopy-based analysis. Considering the simpler use and expected lower cost of LAMP compared with PCR, our findings encourage its evaluation in a larger study over a wider geographical area.
Fil: Rojas Panozo, Lizeth. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; Bolivia
Fil: Rivera Nina, Silvia. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; Bolivia
Fil: Wehrendt, Diana Patricia. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
Fil: Casellas, Aina. Universidad de Barcelona; España
Fil: Pinto, Lilian. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; Bolivia
Fil: Mendez, Susana. Universidad de Barcelona; España
Fil: Kuo, Chi Wei. Ai Biosciences, Inc.; Estados Unidos
Fil: Lozano, Daniel F.. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; Bolivia
Fil: Ortiz, Lourdes. Universidad Autónoma Juan Misael Saracho.; Bolivia
Fil: Pinazo, Maria Jesus. Drugs for Neglected Diseases Initiative; Brasil
Fil: Picado, Albert. Foundation For Innovative New Diagnostics; Suiza
Fil: Sanz, Sergi. Universidad de Barcelona; España
Fil: Abril, Marcelo. Fundación Mundo Sano; Argentina
Fil: Gascon, Joaquim. Universidad de Barcelona; España
Fil: Wong, Season. Ai Biosciences, Inc.; Estados Unidos
Fil: Schijman, Alejandro Gabriel. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
Fil: Torrico, Faustino. Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente ; Bolivia
Fil: Alonso Padilla, Julio. Universidad de Barcelona; España
description Vertical transmission of Trypanosoma cruzi represents approximately 20% of new Chagas disease cases. Early detection and treatment for women of childbearing age and newborns is a public health priority, but the lack of a simple and reliable diagnostic test remains a major barrier. We aimed to evaluate the performance of a point-of-care loop-mediated isothermal amplification (LAMP) assay for the detection of T cruzi. In this proof-of-concept study, we coupled a low-cost 3D printer repurposed for sample preparation and amplification (PrintrLab) to the Eiken T cruzi-LAMP prototype to detect vertically transmitted T cruzi, which we compared with standardised PCR and with the gold-standard algorithm (microscopy at birth and 2 months and serological study several months later). We screened pregnant women from two hospitals in the Bolivian Gran Chaco province, and those who were seropositive for T cruzi were offered the opportunity for their newborns to be enrolled in the study. Newborns were tested by microscopy, LAMP, and PCR at birth and 2 months, and by serology at 8 months.Between April 23 and Nov 17, 2018, 986 mothers were screened, among whom 276 were seropositive for T cruzi (28·0% prevalence, 95% CI 25·6-31·2). In total, 224 infants born to 221 seropositive mothers completed 8 months of follow-up. Congenital transmission was detected in nine of the 224 newborns (4·0% prevalence, 1·9-7·5) by direct microscopy observation, and 14 more cases were diagnosed serologically (6·3%, 3·6-10·3), accounting for an overall vertical transmission rate of 10·3% (6·6-15·0; 23 of 224). All microscopy-positive newborns were positive by PrintrLab-LAMP and by PCR, while these techniques respectively detected four and five extra positive cases among the remaining 215 microscopy-negative newborns. The PrintrLab-LAMP yielded a higher sensitivity than microscopy-based analysis. Considering the simpler use and expected lower cost of LAMP compared with PCR, our findings encourage its evaluation in a larger study over a wider geographical area.
publishDate 2024
dc.date.none.fl_str_mv 2024-09
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
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info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/246113
Rojas Panozo, Lizeth; Rivera Nina, Silvia; Wehrendt, Diana Patricia; Casellas, Aina; Pinto, Lilian; et al.; Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept study; Elsevier; The Lancet Microbe; 5; 9; 9-2024; 1-8
2666-5247
CONICET Digital
CONICET
url http://hdl.handle.net/11336/246113
identifier_str_mv Rojas Panozo, Lizeth; Rivera Nina, Silvia; Wehrendt, Diana Patricia; Casellas, Aina; Pinto, Lilian; et al.; Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: A proof-of-concept study; Elsevier; The Lancet Microbe; 5; 9; 9-2024; 1-8
2666-5247
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
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dc.publisher.none.fl_str_mv Elsevier
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