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dc.contributor.author | Castro-Sesquen, Yagahira E. | |
dc.contributor.author | Tinajeros, Freddy | |
dc.contributor.author | Bern, Caryn | |
dc.contributor.author | Galdos-Cardenas, Gerson | |
dc.contributor.author | Malaga, Edith S. | |
dc.contributor.author | Valencia Ayala, Edward | |
dc.contributor.author | Hjerrild, Kathryn | |
dc.contributor.author | Clipman, Steven J. | |
dc.contributor.author | Lescano Guevara, Andres Guillermo | |
dc.contributor.author | Bayangos, Tabitha | |
dc.contributor.author | Castillo, Walter | |
dc.contributor.author | Menduiña, María Carmen | |
dc.contributor.author | Talaat, Kawsar R. | |
dc.contributor.author | Gilman, Robert Hugh | |
dc.date.accessioned | 2021-10-04T23:01:01Z | |
dc.date.available | 2021-10-04T23:01:01Z | |
dc.date.issued | 2021 | |
dc.identifier.uri | https://hdl.handle.net/20.500.12866/9896 | |
dc.description.abstract | BACKGROUND: Diagnosis of congenital Chagas disease (CChD) in most endemic areas is based on low-sensitive microscopy at birth and 9-month immunoglobulin G (IgG), which has poor adherence. We aim to evaluate the accuracy of the Immunoglobulin M (IgM)-Shed Acute Phase Antigen (SAPA) test in the diagnosis of CChD at birth. METHODS: Two cohort studies (training and validation cohorts) were conducted in 3 hospitals in the department of Santa Cruz, Bolivia. Pregnant women were screened for Chagas disease, and all infants born to seropositive mothers were followed for up to 9 months to diagnose CChD. A composite reference standard was used to determine congenital infection and was based on the parallel use of microscopy, quantitative polymerase chain reaction (qPCR), and IgM-trypomastigote excreted-secreted antigen (TESA) blot at birth and/or 1 month, and/or the detection of anti-Trypanosoma cruzi IgG at 6 or 9 months. The diagnostic accuracy of the IgM-SAPA test was calculated at birth against the composite reference standard. RESULTS: Adherence to the 6- or 9-month follow-up ranged from 25.3% to 59.7%. Most cases of CChD (training and validation cohort: 76.5% and 83.7%, respectively) were detected during the first month of life using the combination of microscopy, qPCR, and/or IgM-TESA blot. Results from the validation cohort showed that when only 1 infant sample obtained at birth was evaluated, the qPCR and the IgM-SAPA test have similar accuracy (sensitivity: range, 79.1%-97.1% and 76.7%-94.3%, respectively, and specificity: 99.5% and 92.6%, respectively). CONCLUSIONS: The IgM-SAPA test has the potential to be implemented as an early diagnostic tool in areas that currently rely only on microscopy | en_US |
dc.description.sponsorship | Este trabajo fue financiado por el Fondo Nacional de Desarrollo Científico, Tecnológico y de Innovación Tecnológica, FONDECYT, Perú [N084-2016]. | es_PE |
dc.language.iso | eng | |
dc.publisher | Oxford University Press | |
dc.relation.ispartofseries | Clinical Infectious Diseases | |
dc.rights | info:eu-repo/semantics/restrictedAccess | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es | |
dc.subject | Female | en_US |
dc.subject | Humans | en_US |
dc.subject | Pregnancy | en_US |
dc.subject | Bolivia | en_US |
dc.subject | Infant | en_US |
dc.subject | Newborn | en_US |
dc.subject | Infant | en_US |
dc.subject | Trypanosoma cruzi | en_US |
dc.subject | Chagas Disease/diagnosis | en_US |
dc.subject | congenital Chagas disease | en_US |
dc.subject | diagnostics | en_US |
dc.subject | gM antibodies | en_US |
dc.subject | shed acute-phase antigen | en_US |
dc.subject | Trypanosoma cruzi | en_US |
dc.subject | Antibodies | en_US |
dc.subject | Protozoan | en_US |
dc.subject | Early Diagnosis | en_US |
dc.subject | Goals | en_US |
dc.subject | Immunoglobulin M | en_US |
dc.subject | Infectious Disease Transmission | en_US |
dc.subject | Vertical | en_US |
dc.title | The Immunoglobulin M-Shed Acute Phase Antigen (SAPA)-test for the Early Diagnosis of Congenital Chagas Disease in the Time of the Elimination Goal of Mother-to-Child Transmission | en_US |
dc.type | info:eu-repo/semantics/article | |
dc.identifier.doi | https://doi.org/10.1093/cid/ciaa986 | |
dc.subject.ocde | https://purl.org/pe-repo/ocde/ford#3.03.08 | |
dc.relation.issn | 1537-6591 |
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