title: Commercial enzyme-linked immunosorbent assay versuspolymerase chain reaction for the diagnosis of chronic Chagas disease: a systematic review and meta-analysis.
abstract: Chronic Chagas disease diagnosis relies on laboratory tests due to its clinical characteristics. The aim of this research was to review commercial enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) diagnostic test performance. Performance of commercial ELISA or PCR for the diagnosis of chronic Chagas disease were systematically searched in PubMed, Scopus, Embase, ISI Web, and LILACS through the bibliography from 1980-2014 and by contact with the manufacturers. The risk of bias was assessed with QUADAS-2. Heterogeneity was estimated with the I2 statistic. Accuracies provided by the manufacturers usually overestimate the accuracy provided by academia. The risk of bias is high in most tests and in most QUADAS dimensions. Heterogeneity is high in either sensitivity, specificity, or both. The evidence regarding commercial ELISA and ELISA-rec sensitivity and specificity indicates that there is overestimation. The current recommendation to use two simultaneous serological tests can be supported by the risk of bias analysis and the amount of heterogeneity but not by the observed accuracies. The usefulness of PCR tests are debatable and health care providers should not order them on a routine basis. PCR may be used in selected cases due to its potential to detect seronegative subjects.
authors.affiliation: Laboratório de Pesquisa Clínica em Doença de Chagas, Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, RJ, Brasil.
authors.forename: Pedro Emmanuel Alvarenga Americano do
authors.initials: PE
authors.lastname: Brasil
authors.affiliation: Laboratório de Pesquisa Clínica em DST e AIDS, Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Brasil.
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Castro
authors.affiliation: Laboratório de Farmacogenética, Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, RJ, Brasil.
authors.forename: Liane de
authors.initials: Ld
authors.lastname: Castro
mesh_terms: D014355:Chagas Disease / Q000175:diagnosis*; D002908:Chronic Disease; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D016133:Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D014349:Trypanosoma cruzi / Q000235:genetics* / Q000276:immunology*
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