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.
Clin Infect Dis
; 73(2): e477-e484, 2021 07 15.
Article
en En
| MEDLINE
| ID: mdl-32667981
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Trypanosoma cruzi
/
Enfermedad de Chagas
Tipo de estudio:
Diagnostic_studies
/
Observational_studies
/
Screening_studies
Límite:
Female
/
Humans
/
Infant
/
Newborn
/
Pregnancy
País/Región como asunto:
America do sul
/
Bolivia
Idioma:
En
Revista:
Clin Infect Dis
Asunto de la revista:
DOENCAS TRANSMISSIVEIS
Año:
2021
Tipo del documento:
Article
País de afiliación:
Estados Unidos