Author | Moreira, Otacilio C. | |
Author | Fernandes, Alice Gomes | |
Author | Gomes, Natalia Lins da Silva | |
Author | Santos, Carolina Messias dos | |
Author | Jacomasso, Thiago | |
Author | Costa, Alexandre Dias Tavares | |
Author | Nascimento, Lucas de O. Rossetti | |
Author | Hasslocher-Moreno, Alejandro Marcel | |
Author | Brasil, Pedro Emmanuel Alvarenga Americano do | |
Author | Morello, Luis Gustavo | |
Author | Marchini, Fabricio Klerynton | |
Author | Krieger, Marco Aurelio | |
Author | Britto, Constança | |
Access date | 2023-05-28T02:12:09Z | |
Available date | 2023-05-28T02:12:09Z | |
Document date | 2023 | |
Citation | MOREIRA, Otacilio C. et al. Validation of the NAT Chagas IVD Kit for the Detection and Quantification of Trypanosoma cruzi in Blood Samples of Patients with Chagas Disease. Life, v. 13, p. 1-16, May 2023. | en_US |
ISSN | 2075-1729 | en_US |
URI | https://www.arca.fiocruz.br/handle/icict/58786 | |
Sponsorship | This research was funded in part by the Coordination for the Improvement of Higher Education Personnel (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-CAPES)— Finance Code 001, Departamento de Ciência e Tecnologia—Ministério da Saúde (DECIT)/Conselho
Nacional de Desenvolvimento Científico e Tecnológico (CNPq) (CNPq/MS/SCTIE/DECIT—grant 467201/2014-5) and Fiocruz (Programa de Desenvolvimento Tecnológico em Insumos para Saúde—RID 34). O.C.M. is a research fellow of CNPq1D and FAPERJ (CNE). C.B. is CNPq research 1B and FAPERJ (CNE). The funders had no role in study design, data collection and analysis, the decision to publish, or the preparation of the manuscript. | en_US |
Language | eng | en_US |
Publisher | MDPI | en_US |
Rights | open access | |
Title | Validation of the NAT Chagas IVD Kit for the Detection and Quantification of Trypanosoma cruzi in Blood Samples of Patients with Chagas Disease | en_US |
Type | Article | |
DOI | 10.3390/ life13061236 | |
Abstract | In the absence of validated biomarkers to control the cure of Chagas disease, PCR-based diagnosis is being used as the main tool for an early indication of therapeutic failure. However, since it is considered a technique of complex reproducibility, mainly due to difficulties in establishing accurate controls to guarantee the quality of the reaction, the use of PCR for Chagas disease diagnosis is restricted to specialized centers. In an effort to disseminate the molecular diagnosis of Chagas disease and its applications, new diagnostic kits based on qPCR have been made available in the market in recent years. Here, we show the results of the validation of the NAT Chagas kit (Nucleic Acid Test for Chagas Disease) for the detection and quantification of T. cruzi in blood samples of patients suspected of Chagas disease infection. The kit, composed of a TaqMan duplex reaction targeting the T. cruzi satellite nuclear DNA and an exogenous internal amplification control, presented a reportable range from 104 to 0.5 parasite equivalents/mL and a limit of detection (LOD) of 0.16 parasite equivalents/mL of blood. In addition, the NAT Chagas kit detected T. cruzi belonging to all six discrete typing units (DTUs—TcI to TcVI), similarly to the in-house real-time PCR performed with commercial reagents, which has been selected as the best performance assay in the international consensus for the validation of qPCR for Chagas disease. In the clinical validation presented here, the kit showed 100% sensitivity and 100% specificity when compared to the consensus in-house real-time PCR assay. Thus, the NAT Chagas kit, which is produced entirely in Brazil under the international standards of good manufacturing practices (GMP), appears as an excellent alternative to enable the molecular diagnosis of Chagas disease in public and private diagnostic centers, as well as to facilitate the monitoring of patients under etiological treatment participating in clinical trials. | en_US |
Affilliation | Oswaldo Cruz Foundation. Oswaldo Cruz Institute. Laboratory of Molecular Virology and Parasitology. Real Time PCR Platform RPT09A. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Oswaldo Cruz Institute. Laboratory of Molecular Biology and Endemic Diseases. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Oswaldo Cruz Institute. Laboratory of Molecular Virology and Parasitology. Real Time PCR Platform RPT09A. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Oswaldo Cruz Institute. Laboratory of Molecular Biology and Endemic Diseases. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Instituto de Biologia Molecular do Paraná. Curitiba, PR, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Carlos Chagas Institute. Laboratory for Applied Science and Technology in Health. Curitiba, PR, Brazil. | en_US |
Affilliation | Instituto de Biologia Molecular do Paraná. Curitiba, PR, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research in Chagas Disease. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research in Chagas Disease. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Instituto de Biologia Molecular do Paraná. Curitiba, PR, Brazil / Oswaldo Cruz Foundation. Carlos Chagas Institute. Laboratory for Applied Science and Technology in Health. Curitiba, PR, Brazil. | en_US |
Affilliation | Instituto de Biologia Molecular do Paraná. Curitiba, PR, Brazil / Oswaldo Cruz Foundation. Carlos Chagas Institute. Laboratory for Applied Science and Technology in Health. Curitiba, PR, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Carlos Chagas Institute. Laboratory for Applied Science and Technology in Health. Curitiba, PR, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Oswaldo Cruz Institute. Laboratory of Molecular Biology and Endemic Diseases. Rio de Janeiro, RJ, Brazil. | en_US |
Subject | Chagas disease | en_US |
Subject | Molecular diagnostics | en_US |
Subject | NAT Chagas | en_US |
Subject | Real-time PCR | en_US |
Subject | Parasite load | en_US |