Author | Silva, Marcele Cabral Couto da | |
Author | Abreu, Letícia C. L. de | |
Author | Carmo, Flavia A. do | |
Author | Rodrigues, Carlos R. | |
Author | Sousa, Valeria P. de | |
Author | Cabral, Lucio M. | |
Access date | 2024-02-29T17:10:19Z | |
Available date | 2024-02-29T17:10:19Z | |
Document date | 2022 | |
Citation | SILVA, Marcele Cabral Couto da et al. Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus. Anais da Academia Brasileira de Ciências, v. 94, suppl. 3, p. 1-16, Nov. 2022. | en_US |
ISSN | 0001-3765 | en_US |
URI | https://www.arca.fiocruz.br/handle/icict/62844 | |
Language | eng | en_US |
Publisher | Academia Brasileira de Ciências | en_US |
Rights | open access | en_US |
Title | Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus | en_US |
Type | Article | en_US |
DOI | 10.1590/0001-3765202220211321 | |
Abstract | The concern about the risks of viral infections transmission through blood transfusion has led into a search for improvements on screening tests used for the selection of blood donors. Molecular biology techniques applied in researches of viral genomes, known as Nucleic Acid-amplification-Test (NAT), represent a technology capable of increasing transfusion safety by shortening the diagnostic window period. In Brazil, the implementation of this technology for the detection of HIV, HCV and HBV occurred due to the implantation of the NAT Kit - produced by Immunobiological Technology Institute (Biomanguinhos-FIOCRUZ), in the Brazilian blood centers. The National Health Surveillance Agency attaches great importance to validation, since it standardizes, disciplines and regulates criteria for the registration of health products. This work aims to establish a protocol of performance validation by real-time PCR method, taking as the object of study the Bio-Manguinhos NAT Kit, in order to update the product registration or to meet any future needs to ensure all regulatory requirements for the performance validation of the real-time PCR diagnostic kit. The protocol developed followed the ICH recommendations. The results revealed that the adopted methodology contemplates the necessary requirements for compliance with the Brazilian legislation, as well as the established validation parameters. | |
Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Rio de Janeiro, RJ, Brasil. | en_US |
Affilliation | Universidade Federal do Rio de Janeiro. Faculdade de Farmácia. Departamento de fármacos e Medicamentos. Rio de Janeiro, RJ, Brasil / Instituto Federal de Educação, Ciência e Tecnologia do Rio de Janeiro. Direção de Ensino. Rio de Janeiro, RJ, Brasil. | en_US |
Affilliation | Universidade Federal do Rio de Janeiro. Faculdade de Farmácia. Departamento de fármacos e Medicamentos. Rio de Janeiro, RJ, Brasil. | en_US |
Affilliation | Universidade Federal do Rio de Janeiro. Faculdade de Farmácia. Departamento de fármacos e Medicamentos. Rio de Janeiro, RJ, Brasil. | en_US |
Affilliation | Universidade Federal do Rio de Janeiro. Faculdade de Farmácia. Departamento de fármacos e Medicamentos. Rio de Janeiro, RJ, Brasil. | en_US |
Affilliation | Universidade Federal do Rio de Janeiro. Faculdade de Farmácia. Departamento de fármacos e Medicamentos. Rio de Janeiro, RJ, Brasil. | en_US |
Subject | Validation studies | en_US |
Subject | Methods | en_US |
Subject | Real-time polymerase chain reaction | en_US |
Subject | Modification of products registration | en_US |