Artículo
Analytical Validation of Quantitative Real-Time PCR Methods for Quantification of Trypanosoma cruzi DNA in Blood Samples from Chagas Disease Patients
Registro en:
10.1016/j.jmoldx.2015.04.010
Autor
Ramírez, Juan Carlos
Cura, Carolina Inés
da Cruz Moreira, Otacilio
Lages-Silva, Eliane
Juiz, Natalia A.
Velazquez, Elsa
Ramírez, Juan David
Alberti, Anahí
Pavia, Paula
Flores-Chávez, María Delmans
Muñoz-Calderón, Arturo
Pérez-Morales, Deyanira
Santalla, José
Marcos da Matta Guedes, Paulo
Peneau, Julie
Marcet, Paula L.
Padilla, Carlos
Cruz-Robles, David
Valencia, Edward
Crisante, Gladys Elena
Greif, Gonzalo
Zulantay, Inés
Costales, Jaime Alfredo
Alvarez-Martínez, Miriam
Martínez, Norma Edith
Villarroel, Rodrigo
Villarroel, Sandro
Sanchez Leon, Zunilda
Bisio, Margarita
Parrado, Rudy
Maria da Cunha Galvão, Lúcia
Jácome da Câmara, Antonia Cláudia
Espinoza, Bertha
Alarcón de Noya, Belkisyole
Puerta, Concepción
Riarte, Adelina
Diosque, Patricio
Sosa-Estani, Sergio
Guhl, Felipe
Ribeiro, Isabela
Aznar, Christine
Britto, Constança
Yadón, Zaida Estela
Schijman, Alejandro G.
Resumen
An international study was performed by 26 experienced PCR laboratories from 14 countries to assess the performance of duplex quantitative real-time PCR (qPCR) strategies on the basis of TaqMan probes for detection and quantification of parasitic loads in peripheral blood samples from Chagas disease patients. Two methods were studied: Satellite DNA (SatDNA) qPCR and kinetoplastid DNA (kDNA) qPCR. Both methods included an internal amplification control. Reportable range, analytical sensitivity, limits of detection and quantification, and precision were estimated according to international guidelines. In addition, inclusivity and exclusivity were estimated with DNA from stocks representing the different Trypanosoma cruzi discrete typing units and Trypanosoma rangeli and Leishmania spp. Both methods were challenged against 156 blood samples provided by the participant laboratories, including samples from acute and chronic patients with varied clinical findings, infected by oral route or vectorial transmission. kDNA qPCR showed better analytical sensitivity than SatDNA qPCR with limits of detection of 0.23 and 0.70 parasite equivalents/mL, respectively. Analyses of clinical samples revealed a high concordance in terms of sensitivity and parasitic loads determined by both SatDNA and kDNA qPCRs. This effort is a major step toward international validation of qPCR methods for the quantification of T. cruzi DNA in human blood samples, aiming to provide an accurate surrogate biomarker for diagnosis and treatment monitoring for patients with Chagas disease.