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

Autor: 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., Castillo W., Menduiña M.C., Talaat K.R., Gilman R.H., Verastegui M., Calderon M., Chávez C., Leigue J.K., Hinojosa E., Urquizu F., Gorena M., Serrudo V., Cabrera L., Romero Y.K., Chagas Working Group in Bolivia and Peru
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Microbiology (medical)
Chagas disease
medicine.medical_specialty
Bolivia
Mother to child transmission
Trypanosoma cruzi
Infectious Disease Transmission
030231 tropical medicine
Congenital Chagas disease
Diagnostics
IgM antibodies
Shed acute-phase antigen
Antibodies
Protozoan
purl.org/pe-repo/ocde/ford#3.03.08 [https]
Immunoglobulin G
Antibodies
Poor adherence
03 medical and health sciences
0302 clinical medicine
Antigen
congenital Chagas disease
Pregnancy
Internal medicine
parasitic diseases
diagnostics
Medicine
Humans
Vertical
Chagas Disease
030212 general & internal medicine
Online Only Articles
gM antibodies
biology
Chagas Disease/diagnosis
business.industry
Infant
Newborn
Infant
medicine.disease
Newborn
Infectious Disease Transmission
Vertical
Infectious Diseases
Real-time polymerase chain reaction
Early Diagnosis
Immunoglobulin M
shed acute-phase antigen
Protozoan
biology.protein
Female
business
Goals
Cohort study
Zdroj: CONCYTEC-Institucional
Consejo Nacional de Ciencia Tecnología e Innovación Tecnológica
instacron:CONCYTEC
Clin Infect Dis
Popis: 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.
Databáze: OpenAIRE
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