Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus
Autor(a) principal: | |
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Data de Publicação: | 2022 |
Outros Autores: | , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Anais da Academia Brasileira de Ciências (Online) |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0001-37652022000700710 |
Resumo: | 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. |
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Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virusvalidation studiesmethodsreal-time polymerase chain reactionmodification of products registrationAbstract 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.Academia Brasileira de Ciências2022-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0001-37652022000700710Anais da Academia Brasileira de Ciências v.94 suppl.3 2022reponame:Anais da Academia Brasileira de Ciências (Online)instname:Academia Brasileira de Ciências (ABC)instacron:ABC10.1590/0001-3765202220211321info:eu-repo/semantics/openAccessSILVA,MARCELE C.C. DAABREU,LETÍCIA C.L. DECARMO,FLAVIA A. DORODRIGUES,CARLOS R.SOUSA,VALERIA P. DECABRAL,LUCIO M.eng2022-11-17T00:00:00Zoai:scielo:S0001-37652022000700710Revistahttp://www.scielo.br/aabchttps://old.scielo.br/oai/scielo-oai.php||aabc@abc.org.br1678-26900001-3765opendoar:2022-11-17T00:00Anais da Academia Brasileira de Ciências (Online) - Academia Brasileira de Ciências (ABC)false |
dc.title.none.fl_str_mv |
Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus |
title |
Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus |
spellingShingle |
Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus SILVA,MARCELE C.C. DA validation studies methods real-time polymerase chain reaction modification of products registration |
title_short |
Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus |
title_full |
Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus |
title_fullStr |
Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus |
title_full_unstemmed |
Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus |
title_sort |
Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus |
author |
SILVA,MARCELE C.C. DA |
author_facet |
SILVA,MARCELE C.C. DA ABREU,LETÍCIA C.L. DE CARMO,FLAVIA A. DO RODRIGUES,CARLOS R. SOUSA,VALERIA P. DE CABRAL,LUCIO M. |
author_role |
author |
author2 |
ABREU,LETÍCIA C.L. DE CARMO,FLAVIA A. DO RODRIGUES,CARLOS R. SOUSA,VALERIA P. DE CABRAL,LUCIO M. |
author2_role |
author author author author author |
dc.contributor.author.fl_str_mv |
SILVA,MARCELE C.C. DA ABREU,LETÍCIA C.L. DE CARMO,FLAVIA A. DO RODRIGUES,CARLOS R. SOUSA,VALERIA P. DE CABRAL,LUCIO M. |
dc.subject.por.fl_str_mv |
validation studies methods real-time polymerase chain reaction modification of products registration |
topic |
validation studies methods real-time polymerase chain reaction modification of products registration |
description |
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. |
publishDate |
2022 |
dc.date.none.fl_str_mv |
2022-01-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0001-37652022000700710 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0001-37652022000700710 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.1590/0001-3765202220211321 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Academia Brasileira de Ciências |
publisher.none.fl_str_mv |
Academia Brasileira de Ciências |
dc.source.none.fl_str_mv |
Anais da Academia Brasileira de Ciências v.94 suppl.3 2022 reponame:Anais da Academia Brasileira de Ciências (Online) instname:Academia Brasileira de Ciências (ABC) instacron:ABC |
instname_str |
Academia Brasileira de Ciências (ABC) |
instacron_str |
ABC |
institution |
ABC |
reponame_str |
Anais da Academia Brasileira de Ciências (Online) |
collection |
Anais da Academia Brasileira de Ciências (Online) |
repository.name.fl_str_mv |
Anais da Academia Brasileira de Ciências (Online) - Academia Brasileira de Ciências (ABC) |
repository.mail.fl_str_mv |
||aabc@abc.org.br |
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1754302872815665152 |