ARCHITECT Chagas (R) as a single test candidate for Chagas disease diagnosis: evaluation of two algorithms implemented in a non-endemic setting

Objectives: To evaluate two algorithms for the diagnosis of chronic and congenital Chagas disease (CD), both including the chemiluminescent microparticle immunoassay ARCHITECT Chagas (R) (CMIA) as a single test but with an amended signal-to-cut-off ratio (S/CO) of >= 6, instead of an S/CO of >...

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Autores: Abras, A, Ballart, C, Fernandez-Arevalo, A, Llovet, T, Gallego, M, Munoz, C
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2021
País:España
Recursos:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositório:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p4721
Acesso em linha:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4721
Access Level:Acceso aberto
Palavra-chave:ARCHITECT Chagas (R)
Chagas disease
Serology
Spain
Trypanosoma cruzi
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spelling ARCHITECT Chagas (R) as a single test candidate for Chagas disease diagnosis: evaluation of two algorithms implemented in a non-endemic settingAbras, ABallart, CFernandez-Arevalo, ALlovet, TGallego, MMunoz, CARCHITECT Chagas (R)Chagas diseaseSerologySpainTrypanosoma cruziObjectives: To evaluate two algorithms for the diagnosis of chronic and congenital Chagas disease (CD), both including the chemiluminescent microparticle immunoassay ARCHITECT Chagas (R) (CMIA) as a single test but with an amended signal-to-cut-off ratio (S/CO) of >= 6, instead of an S/CO of >= 1 as indicated by the manufacturer. Methods: The study encompassed two panels of retrospective samples: 831 sera from 786 adolescents and adults (panel A), and 96 sera from 35 newborn infants with CD-infected mothers (panel B). A CMIA-negative result was deemed conclusive, whereas samples with an S/CO >= 0.8 were confirmed by a second test (BioELISA Chagas, ELISAr). Results: In panel A, seropositivity was 13% (102/786); 10 samples gave discordant results for CMIA and ELISAr, all of which were CMIA positive and had CD confirmed through a previous diagnosis by two positive serological tests. In panel B, all newborns were considered non-infected based on both a progressive decrease in antibody titres over time and negative real-time PCR results. CMIA still gave positive results in two infants aged 10 months but no S/CO values >6 were observed from 4 months on. Conclusions: CMIA is a firm candidate for use as a single CD diagnostic test in non-endemic countries. The algorithm with the >= 6 S/CO is as an efficient method for chronic CD diagnosis. CMIA could also be used as a single test to screen infants for congenital infection at the age of 10 months or even earlier if applying the corrected cut-off ratio, although further studies are required. (C) 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.ELSEVIER SCI LTD2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4721CLINICAL MICROBIOLOGY AND INFECTIONISSN: 1198743XISSNe: 14690691reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p47212026-06-14T12:41:47Z
dc.title.none.fl_str_mv ARCHITECT Chagas (R) as a single test candidate for Chagas disease diagnosis: evaluation of two algorithms implemented in a non-endemic setting
title ARCHITECT Chagas (R) as a single test candidate for Chagas disease diagnosis: evaluation of two algorithms implemented in a non-endemic setting
spellingShingle ARCHITECT Chagas (R) as a single test candidate for Chagas disease diagnosis: evaluation of two algorithms implemented in a non-endemic setting
Abras, A
ARCHITECT Chagas (R)
Chagas disease
Serology
Spain
Trypanosoma cruzi
title_short ARCHITECT Chagas (R) as a single test candidate for Chagas disease diagnosis: evaluation of two algorithms implemented in a non-endemic setting
title_full ARCHITECT Chagas (R) as a single test candidate for Chagas disease diagnosis: evaluation of two algorithms implemented in a non-endemic setting
title_fullStr ARCHITECT Chagas (R) as a single test candidate for Chagas disease diagnosis: evaluation of two algorithms implemented in a non-endemic setting
title_full_unstemmed ARCHITECT Chagas (R) as a single test candidate for Chagas disease diagnosis: evaluation of two algorithms implemented in a non-endemic setting
title_sort ARCHITECT Chagas (R) as a single test candidate for Chagas disease diagnosis: evaluation of two algorithms implemented in a non-endemic setting
dc.creator.none.fl_str_mv Abras, A
Ballart, C
Fernandez-Arevalo, A
Llovet, T
Gallego, M
Munoz, C
author Abras, A
author_facet Abras, A
Ballart, C
Fernandez-Arevalo, A
Llovet, T
Gallego, M
Munoz, C
author_role author
author2 Ballart, C
Fernandez-Arevalo, A
Llovet, T
Gallego, M
Munoz, C
author2_role author
author
author
author
author
dc.subject.none.fl_str_mv ARCHITECT Chagas (R)
Chagas disease
Serology
Spain
Trypanosoma cruzi
topic ARCHITECT Chagas (R)
Chagas disease
Serology
Spain
Trypanosoma cruzi
description Objectives: To evaluate two algorithms for the diagnosis of chronic and congenital Chagas disease (CD), both including the chemiluminescent microparticle immunoassay ARCHITECT Chagas (R) (CMIA) as a single test but with an amended signal-to-cut-off ratio (S/CO) of >= 6, instead of an S/CO of >= 1 as indicated by the manufacturer. Methods: The study encompassed two panels of retrospective samples: 831 sera from 786 adolescents and adults (panel A), and 96 sera from 35 newborn infants with CD-infected mothers (panel B). A CMIA-negative result was deemed conclusive, whereas samples with an S/CO >= 0.8 were confirmed by a second test (BioELISA Chagas, ELISAr). Results: In panel A, seropositivity was 13% (102/786); 10 samples gave discordant results for CMIA and ELISAr, all of which were CMIA positive and had CD confirmed through a previous diagnosis by two positive serological tests. In panel B, all newborns were considered non-infected based on both a progressive decrease in antibody titres over time and negative real-time PCR results. CMIA still gave positive results in two infants aged 10 months but no S/CO values >6 were observed from 4 months on. Conclusions: CMIA is a firm candidate for use as a single CD diagnostic test in non-endemic countries. The algorithm with the >= 6 S/CO is as an efficient method for chronic CD diagnosis. CMIA could also be used as a single test to screen infants for congenital infection at the age of 10 months or even earlier if applying the corrected cut-off ratio, although further studies are required. (C) 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4721
url https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4721
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv ELSEVIER SCI LTD
publisher.none.fl_str_mv ELSEVIER SCI LTD
dc.source.none.fl_str_mv CLINICAL MICROBIOLOGY AND INFECTION
ISSN: 1198743X
ISSNe: 14690691
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
instname_str Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
reponame_str r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
collection r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
repository.name.fl_str_mv
repository.mail.fl_str_mv
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