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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

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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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