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dc.contributor.authorFlores-Chavez, Maria 
dc.contributor.authorSambri, Vittorio
dc.contributor.authorSchottstedt, Volkmar
dc.contributor.authorHiguera-Escalante, Fernando Aparicio
dc.contributor.authorRoessler, Dieter
dc.contributor.authorChaves, Monica
dc.contributor.authorLaengin, Tina
dc.contributor.authorMartinez, Alfredo
dc.contributor.authorFleischer, Bernhard
dc.date.accessioned2022-03-30T10:06:54Z
dc.date.available2022-03-30T10:06:54Z
dc.date.issued2018
dc.identifier.citationJ Clin Microbiol. 2018 ;56(5):e01446-17.es_ES
dc.identifier.urihttp://hdl.handle.net/20.500.12105/13908
dc.description.abstractSerology is the preferred method to confirm a Chagas disease diagnosis and to screen blood donors. A battery of assays is often required due to the limited accuracy of single assays. The Elecsys Chagas assay is a newly developed, double-antigen sandwich assay for use on the Elecsys and cobas e immunoassay analyzers, intended to identify individuals infected with Trypanosoma cruzi, for diagnosis and screening. The performance of the Elecsys Chagas assay was evaluated in comparison with those of other widely used T. cruzi antibody assays, at multiple sites (Europe/Latin America). Relative sensitivity and specificity were assessed by using samples from blood donors, pregnant women, and hospitalized patients from regions where Chagas disease is endemic and from regions of nonendemicity. The Elecsys Chagas assay had an overall relative sensitivity of 100% (n = 674). Overall relative specificities were 99.90% (n = 14,681), 100% (n = 313), and 100% (n = 517) for samples from blood donors, pregnant women, and hospitalized patients, respectively. The analytical specificity was 99.83% (n = 594). The Elecsys Chagas assay detected T. cruzi antibodies in two World Health Organization (WHO) standard T. cruzi reference panels (panels 09/188 and 09/186) at a 1:512 dilution, corresponding to a cutoff sensitivity of approximately 1 mIU/ml. The Elecsys Chagas assay demonstrated robust performance under routine conditions at multiple sites in Europe and Latin America. In contrast to other available Chagas assays, the Elecsys assay uses a reduced number of recombinant T. cruzi antigens, resulting in a significantly smaller number of cross-reactions and improved analytical specificity while being highly sensitive.es_ES
dc.description.sponsorshipThis study was funded by Roche Diagnostics (Penzberg, Germany). Medical writing assistance was provided by David Evans and Emma McConnell (Gardiner-Caldwell Communications, Macclesfield, UK) and was funded by Roche Diagnostics (Penzberg, Germany). We thank the Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET) and Miguel Vicco from the Universidad Nacional del Litoral (Santa Fe, Argentina) for the provision of Chagas-positive samples; DiaSorin SpA (Saluggia, Italy) for the free-ofcharge provision of DiaSorin Liaison XL Murex Chagas for measurements performed at the Greater Romagna Hub Laboratory in Pievesestina, Italy; and Sigrid Reichhuber, Verena Rauchberger, Stefanie Hornauer, Michaela Eibl, and Christian Schuster for perfect technical assistance. All authors fulfill International Committee of Medical Journal Editors authorship criteria. Maria Delmans Flores-Chavez received funds from Roche Diagnostics to perform this study and received a speaker fee from Roche Diagnostics. Vittorio Sambri received research grants from Grifols, Abbott Iridica, Siemens Diagnostics, and DiaSorin; speaker fees from Abbott Diagnostics, DiaSorin, and Beckman Coulter; and funds from Roche Diagnostics to perform this study. Volkmar Schottstedt received funds from Roche Diagnostics to perform this study. Fernando Aparicio Higuera-Escalante received funds from Roche Diagnostics to perform this study. Dieter Roessler is employed by Roche Diagnostics. Monica Chaves is employed by Roche Diagnostics. Tina Laengin is employed by Roche Diagnostics. Alfredo Martinez received funds from Roche Diagnostics to perform this study and received a speaker fee from Roche Diagnostics. Bernhard Fleischer received funds from Roche Diagnostics to perform this study and received a speaker fee from Roche Diagnostics.es_ES
dc.language.isoenges_ES
dc.publisherAmerican Society for Microbiology (ASM) es_ES
dc.type.hasVersionVoRes_ES
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectChagas diseasees_ES
dc.subjectTrypanosoma cruzies_ES
dc.subjectSerologyes_ES
dc.subjectElectrochemiluminescence immunoassayes_ES
dc.subject.meshAntibodies, Protozoan es_ES
dc.subject.meshChagas Disease es_ES
dc.subject.meshEurope es_ES
dc.subject.meshFemale es_ES
dc.subject.meshHumans es_ES
dc.subject.meshImmunoassay es_ES
dc.subject.meshLatin America es_ES
dc.subject.meshMale es_ES
dc.subject.meshPregnancy es_ES
dc.subject.meshSensitivity and Specificity es_ES
dc.subject.meshSerologic Tests es_ES
dc.subject.meshTrypanosoma cruzi es_ES
dc.titleEvaluation of the Elecsys Chagas Assay for Detection of Trypanosoma cruzi-Specific Antibodies in a Multicenter Study in Europe and Latin Americaes_ES
dc.typejournal articlees_ES
dc.rights.licenseAtribución 4.0 Internacional*
dc.identifier.pubmedID29444836es_ES
dc.format.volume56es_ES
dc.format.number5es_ES
dc.format.pagee01446-17es_ES
dc.identifier.doi10.1128/JCM.01446-17es_ES
dc.contributor.funderRoche es_ES
dc.contributor.funderGrifols (Spain) es_ES
dc.contributor.funderAbbott es_ES
dc.contributor.funderSiemenses_ES
dc.contributor.funderDiaSorines_ES
dc.description.peerreviewedes_ES
dc.identifier.e-issn1098-660Xes_ES
dc.relation.publisherversionhttps://doi.org/10.1128/JCM.01446-17es_ES
dc.identifier.journalJournal of Clinical Microbiologyes_ES
dc.repisalud.centroISCIII::Centro Nacional de Microbiologíaes_ES
dc.repisalud.institucionISCIIIes_ES
dc.rights.accessRightsopen accesses_ES


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Atribución 4.0 Internacional
Este Item está sujeto a una licencia Creative Commons: Atribución 4.0 Internacional