Congenital Chagas disease: A cohort study to assess molecular diagnostic methods at the Chagas disease national reference center of Argentina

Background: Trypanosoma cruzi is a protozoan parasite which causes Chagas disease. Mother-to-child transmission is the main route of transmission in vector-free areas. Congenital Chagas disease refers specifically to cases arising from this route of transmission. This work evaluates the clinical sensitivity of two qPCR techniques for diagnosis of congenital Chagas disease. Methods: The study was developed in the National Institute of parasitology (NIP), Argentina, and Pan-American Health Organization/ Word Health Organization Collaborating Center for Chagas Disease. Between July 2014 and May 2018, a prospective cohort study was carried out with 499 children born to seropositive for T. cruzi infection included. The performance of qPCR techniques was compared with the gold standard diagnostic algorithm for Congenital Chagas disease (CCD-GS), which comprises performing more than one parasitological test on children from birth until nine months of age, and serology from ten months of age. Findings: Of the 961 babies born to women seropositive for Chagas disease who were attended at the NIP laboratory, 462 did not meet the study inclusion criteria; 22 cases were diagnosed with congenital Chagas disease. qPCR showed 100% clinical sensitivity and 98 to 100% clinical specificity for the diagnosis of congenital Chagas disease compared with CCD-GS algorithm. Interpretation: The results obtained in this study demonstrate the clinical accuracy and effectiveness of qPCR SatDNA and qPCR kDNA for diagnosis of congenital Chagas disease. It could be a powerful tool for chagas test and treat strategies to reduce late complications of the disease. Funding: This work was financed by the INP Dr. Mario Fatala Chaben, ANLIS Dr. Carlos G. Malbran. Author summary: Trypanosoma cruzi is a protozoan parasite which causes Chagas disease. Mother-to-child transmission is the main route of transmission in vector-free areas. Congenital Chagas disease refers specifically to cases arising from this route of transmission. Diagnostic for Congenital Chagas disease comprises performing more than one test on children from birth until nine months of age, to ten months of age. This work evaluates two qPCR techniques for diagnosis of congenital Chagas disease with high sensitivity and bring treatment during the period in which tripanocydal drugs has high efficacy.