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

被引：15

作者：

Francisco Benatar, Alejandro ^{[1
]}

Danesi, Emmaria ^{[2
]}

Alicia Besuschio, Susana ^{[1
]}

Bortolotti, Santiago ^{[3
]}

Luisa Cafferata, Maria ^{[4
]}

Carlos Ramirez, Juan ^{[1
]}

Lopez Albizu, Constanza ^{[5
]}

Scollo, Karenina ^{[5
]}

Baleani, Maria ^{[3
]}

Lara, Laura ^{[6
]}

Agolti, Gustavo ^{[7
]}

Seu, Sandra ^{[8
]}

Adamo, Elsa ^{[9
]}

Horacio Lucero, Raul ^{[10
]}

Irazu, Lucia ^{[11
]}

Rodriguez, Marcelo ^{[11
]}

Poeylaut-Palena, Andres ^{[3
]}

Andrea Longhi, Silvia ^{[1
]}

Esteva, Monica ^{[5
]}

Althabe, Fernando ^{[4
]}

Rojkin, Federico ^{[3
]}

Bua, Jacqueline ^{[5
]}

Sosa-Estani, Sergio ^{[4
,5
]}

Gabriel Schijman, Alejandro ^{[1
]}

机构：

[1] Consejo Nacl Invest Cient & Tecn, CONICET, Inst Invest Ingn Genet & Biol Mol Dr Hector Torre, Lab Biol Mol Enfermedad Chagas LaBMECh, Buenos Aires, DF, Argentina

[2] Ctr Nacl Diagnost & Invest Endemoepidemias ANLIS, Buenos Aires, DF, Argentina

[3] Ctr Invest & Biotecnol CIBIO Wiener Labs SAIC, Rosario, Pcia De Santa F, Argentina

[4] Inst Efectividad Clin & Sanitaria, Dept Salud Madre & Nino, Buenos Aires, DF, Argentina

[5] Inst Nacl Parasitol Dr M Fatala Chaben, Adm Nacl Labs & Inst Salud Carlos G Malbran ANLIS, Buenos Aires, DF, Argentina

[6] Inst Maternidad & Ginecol Nuestra Senora Mercedes, San Miguel De Tucuman, Pcia De Tucuman, Argentina

[7] Hosp Dr Julio Cesar Perrando, Resistencia, Pcia De Santiag, Argentina

[8] Hosp Reg Dr Ramon Carrillo, Santiago Del Estero, Pcia De Santiag, Argentina

[9] Ctr Integral Salud La Banda, La Banda, Pcia De Santiag, Argentina

[10] Univ Nacl Nordeste IMR UNNE, Inst Med Reg, Resistencia, Provincia De Ch, Argentina

[11] Adm Nacl Labs & Inst Salud Carlos G Malbran ANLIS, Dept Calidad, Buenos Aires, DF, Argentina

来源：

EBIOMEDICINE | 2021年 / 69卷

关键词：

Congenital Chagas disease; Early diagnosis; Real Time PCR; Trypanosoma cruzi; Discrete typing unit; Parasitic load; TRYPANOSOMA-CRUZI INFECTION; OPERATING CHARACTERISTIC CURVES; POLYMERASE-CHAIN-REACTION; VERTICAL TRANSMISSION; DNA; QUANTIFICATION; AREAS;

D O I：

10.1016/j.ebiom.2021.103450

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. (C) 2021 The Authors. Published by Elsevier B.V.

引用

页数：12