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Artículo

Prospective multicenter evaluation of real time PCR Kit prototype for early diagnosis of congenital Chagas disease

Benatar, Alejandro FranciscoIcon ; Danesi, Emmaría; Besuschio, Susana Alicia; Bortolotti, Santiago; Cafferata, María Luisa; Ramirez Gomez, Juan CarlosIcon ; Lopez Albizu, Maria Constanza; Scollo, Karenina; Baleani, María; Lara, Laura; Agolti, Gustavo; Seu, Sandra; Adamo, Elsa; Lucero, Raul Horacio; Irazu, Lucía; Rodriguez, Marcelo; Poeylaut Palena, Andrés AlbertoIcon ; Longhi, Silvia AndreaIcon ; Esteva, Mónica Inés; Althabe, FernandoIcon ; Rojkin, Federico; Bua, Jacqueline ElenaIcon ; Sosa-Estani, Sergio AlejandroIcon ; Schijman, Alejandro GabrielIcon ; Congenital Chagas Disease Study Group
Fecha de publicación: 07/2021
Editorial: Elsevier
Revista: EBioMedicine
ISSN: 2352-3964
Idioma: Inglés
Tipo de recurso: Artículo publicado
Clasificación temática:
Bioquímica y Biología Molecular

Resumen

Background: Current algorithm for Congenital Chagas Disease (cCD) diagnosis is unsatisfactory due to low sensitivity of the parasitological methods. Moreover, loss to follow-up precludes final serodiagnosis after nine months of life in many cases. A duplex TaqMan qPCR kit for Trypanosoma cruzi DNA amplification was prospectively evaluated in umbilical cord (UCB) and peripheral venous blood (PVB) of infants born to CD mothers at endemic and non-endemic sites of Argentina. Methods: We enrolled and followed-up 370 infants; qPCR was compared to gold-standard cCD diagnosis following studies of diagnostic accuracy guidelines. Findings: Fourteen infants (3·78%) had cCD. The qPCR sensitivity and specificity were higher in PVB (72·73%, 99·15% respectively) than in UCB (66·67%, 96·3%). Positive and negative predictive values were 80 and 98·73% and 50 and 98·11% for PVB and UCB, respectively. The Areas under the Curve (AUC) of ROC analysis for qPCR and micromethod (MM) were 0·81 and 0·67 in UCB and 0·86 and 0·68 in PVB, respectively. Parasitic loads ranged from 37·5 to 23,709 parasite equivalents/mL. Discrete typing Unit Tc V was identified in five cCD patients and in six other cCD cases no distinction among Tc II, Tc V or Tc VI was achieved. Interpretation: This first prospective field study demonstrated that qPCR was more sensitive than MM for early cCD detection and more accurate in PVB than in UCB. Its use, as an auxiliary diagnostic tool to MM will provide more accurate records on cCD incidence. Funding: FITS SALUD 001-CHAGAS (FONARSEC, MINCyT, Argentina) to the Public-Private Consortium (INGEBI-CONICET, INP-ANLIS MALBRAN and Wiener Laboratories); ERANET-LAC-HD 328 to AGS and PICT 2015-0074 (FONCYT, MinCyT) to AGS and FA.
Palabras clave: CONGENITAL CHAGAS DISEASE , DISCRETE TYPING UNIT , EARLY DIAGNOSIS , PARASITIC LOAD , REAL TIME PCR , TRYPANOSOMA CRUZI
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info:eu-repo/semantics/openAccess Excepto donde se diga explícitamente, este item se publica bajo la siguiente descripción: Atribución-NoComercial-SinDerivadas 2.5 Argentina (CC BY-NC-ND 2.5 AR)
Identificadores
URI: http://hdl.handle.net/11336/149025
URL: https://www.sciencedirect.com/science/article/pii/S2352396421002437
DOI: https://doi.org/10.1016/j.ebiom.2021.103450
Colecciones
Articulos(CIESP)
Articulos de CENTRO DE INVESTIGACIONES EN EPIDEMIOLOGIA Y SALUD PUBLICA
Articulos(INGEBI)
Articulos de INST.DE INVEST.EN ING.GENETICA Y BIOL.MOLECULAR "DR. HECTOR N TORRES"
Articulos(SEDE CENTRAL)
Articulos de SEDE CENTRAL
Citación
Benatar, Alejandro Francisco; Danesi, Emmaría; Besuschio, Susana Alicia; Bortolotti, Santiago; Cafferata, María Luisa; et al.; Prospective multicenter evaluation of real time PCR Kit prototype for early diagnosis of congenital Chagas disease; Elsevier; EBioMedicine; 69; 7-2021; 1-12
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