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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
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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Fecha
2021
Autores
Castro-Sesquen Y.E.
Tinajeros F.
Bern C.
Galdos-Cardenas G.
Malaga E.S.
Valencia Ayala E.
Hjerrild K.
Clipman S.J.
Lescano A.G.
Bayangos T.
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Oxford University Press
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Abstracto
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. © 2020 The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved.
Descripción
The work was supported by Fondo Nacional de Desarrollo Cientifico, Tecnologico y de Innovacion Tecnologica, FONDECYT, Peru (N084-2016) to Y. E. C.-S.; the National Institutes of Health (R01-AI87776 and D43-TW010074 to R. H. G. and D43 TW007393 to A. G. L.); and InBios International, Inc to R. H. G. through the Johns Hopkins Bloomberg School of Public Health.
Palabras clave
Trypanosoma cruzi,
Congenital Chagas disease,
Diagnostics,
IgM antibodies,
Shed acute-phase antigen