Metrological traceability in laboratory medicine: study of biochemistry kits used in clinical pathology laboratories
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Data de Publicação: | 2015 |
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Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Vigilância Sanitária em Debate |
Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/531 |
Resumo: | The importance of metrological traceability in the manufacture of diagnostic kits is not well understood in the laboratory community. Therefore, its influence on method validation and the production of accurate and comparable results in clinical laboratories is rarely discussed. This study aims to contribute to the dissemination of the knowledge of metrological traceability and emphasize the importance of using Certified Reference Materials (CRMs) or reference methods (RFs) during the manufacture of diagnostic kits. According to our study, metrological traceability was exclusively demonstrated through the use of CRMs in 57% of cases and through that of RFs in 26% of cases. For the diagnostic kits that used CRMs during the manufacturing process, the CRMs were sourced exclusively from NIST (National Institute of Standards and Technology). Other results of the study indicate that 46% of the diagnostic kits reported to be used in the proficiency testing program at ControlLab - Biochemistry are produced in Brazil, which demonstrates the importance of the national industry. However, with respect to metrological traceability, 14% of the 121 diagnostic kits surveyed did not inform about metrological traceability, and all of them were manufactured in Brazil. This suggests that some Brazilian manufacturers are not attentive to the dissemination of metrological traceability information as a means of attesting to the quality of their product. |
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Metrological traceability in laboratory medicine: study of biochemistry kits used in clinical pathology laboratoriesRastreabilidade metrológica em medicina laboratorial. Estudo de kits de bioquímica utilizados em laboratórios de análises clínicasRastreabilidade MetrológicaAnálises ClínicasMaterial de ReferênciaMaterial de Referência CertificadoMétodo de ReferênciaMetrological TraceabilityClinical AnalysisReference MaterialCertified Reference MaterialReference MethodThe importance of metrological traceability in the manufacture of diagnostic kits is not well understood in the laboratory community. Therefore, its influence on method validation and the production of accurate and comparable results in clinical laboratories is rarely discussed. This study aims to contribute to the dissemination of the knowledge of metrological traceability and emphasize the importance of using Certified Reference Materials (CRMs) or reference methods (RFs) during the manufacture of diagnostic kits. According to our study, metrological traceability was exclusively demonstrated through the use of CRMs in 57% of cases and through that of RFs in 26% of cases. For the diagnostic kits that used CRMs during the manufacturing process, the CRMs were sourced exclusively from NIST (National Institute of Standards and Technology). Other results of the study indicate that 46% of the diagnostic kits reported to be used in the proficiency testing program at ControlLab - Biochemistry are produced in Brazil, which demonstrates the importance of the national industry. However, with respect to metrological traceability, 14% of the 121 diagnostic kits surveyed did not inform about metrological traceability, and all of them were manufactured in Brazil. This suggests that some Brazilian manufacturers are not attentive to the dissemination of metrological traceability information as a means of attesting to the quality of their product.A importância da rastreabilidade metrológica na produção de kits (conjuntos diagnósticos) não é de domínio da comunidade laboratorial e, consequentemente, sua influência em validações de métodos e produção de resultados exatos e comparáveis nos laboratórios é pouco discutida. Este estudo espera contribuir para a disseminação deste conhecimento e evidenciar, para a comunidade de laboratoristas, a importância de realizar seus exames com conjuntos diagnósticos que utilizem Material de Referência Certificado (MRC) ou Método de Referência (MetR) em sua produção. O presente estudo evidencia que a rastreabilidade metrológica foi exclusivamente demonstrada pelo uso de MRC em 57% dos casos e em 26% pelo uso de MetR. Para os conjuntos diagnósticos em que os MRC foram utilizados no processo de fabricação, estes tiveram origem exclusiva do NIST (National Institute os Standards and Technology). Os resultados do estudo indicam que 46% dos conjuntos diagnósticos reportados no ensaio de proficiência da ControlLab – Bioquímica I são produzidos no Brasil, o que demonstra a importância desta indústria no nosso mercado. Entretanto, no que concerne à informação sobre rastreabilidade metrológica, dos 121 conjuntos diagnósticos pesquisados, 14% não informam rastreabilidade e todos são produtos nacionais, sugerindo que existem fabricantes que não estão atentos à disseminação desta informação como forma de atestar a qualidade do seu produto.Instituto Nacional de Controle de Qualidade em Saúde2015-11-27info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/53110.3395/2317-269x.00531Health Surveillance under Debate: Society, Science & Technology ; Vol. 3 No. 4 (2015): November; 68-73Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 3 Núm. 4 (2015): Noviembre; 68-73Vigil Sanit Debate, Rio de Janeiro; v. 3 n. 4 (2015): Novembro; 68-732317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/531/258Copyright (c) 2015 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessPessoa, Maria Cristina FerreiraFerreira Jr., Orlando Costa2023-06-27T15:18:07Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/531Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:18:07Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Metrological traceability in laboratory medicine: study of biochemistry kits used in clinical pathology laboratories Rastreabilidade metrológica em medicina laboratorial. Estudo de kits de bioquímica utilizados em laboratórios de análises clínicas |
title |
Metrological traceability in laboratory medicine: study of biochemistry kits used in clinical pathology laboratories |
spellingShingle |
Metrological traceability in laboratory medicine: study of biochemistry kits used in clinical pathology laboratories Pessoa, Maria Cristina Ferreira Rastreabilidade Metrológica Análises Clínicas Material de Referência Material de Referência Certificado Método de Referência Metrological Traceability Clinical Analysis Reference Material Certified Reference Material Reference Method |
title_short |
Metrological traceability in laboratory medicine: study of biochemistry kits used in clinical pathology laboratories |
title_full |
Metrological traceability in laboratory medicine: study of biochemistry kits used in clinical pathology laboratories |
title_fullStr |
Metrological traceability in laboratory medicine: study of biochemistry kits used in clinical pathology laboratories |
title_full_unstemmed |
Metrological traceability in laboratory medicine: study of biochemistry kits used in clinical pathology laboratories |
title_sort |
Metrological traceability in laboratory medicine: study of biochemistry kits used in clinical pathology laboratories |
author |
Pessoa, Maria Cristina Ferreira |
author_facet |
Pessoa, Maria Cristina Ferreira Ferreira Jr., Orlando Costa |
author_role |
author |
author2 |
Ferreira Jr., Orlando Costa |
author2_role |
author |
dc.contributor.author.fl_str_mv |
Pessoa, Maria Cristina Ferreira Ferreira Jr., Orlando Costa |
dc.subject.por.fl_str_mv |
Rastreabilidade Metrológica Análises Clínicas Material de Referência Material de Referência Certificado Método de Referência Metrological Traceability Clinical Analysis Reference Material Certified Reference Material Reference Method |
topic |
Rastreabilidade Metrológica Análises Clínicas Material de Referência Material de Referência Certificado Método de Referência Metrological Traceability Clinical Analysis Reference Material Certified Reference Material Reference Method |
description |
The importance of metrological traceability in the manufacture of diagnostic kits is not well understood in the laboratory community. Therefore, its influence on method validation and the production of accurate and comparable results in clinical laboratories is rarely discussed. This study aims to contribute to the dissemination of the knowledge of metrological traceability and emphasize the importance of using Certified Reference Materials (CRMs) or reference methods (RFs) during the manufacture of diagnostic kits. According to our study, metrological traceability was exclusively demonstrated through the use of CRMs in 57% of cases and through that of RFs in 26% of cases. For the diagnostic kits that used CRMs during the manufacturing process, the CRMs were sourced exclusively from NIST (National Institute of Standards and Technology). Other results of the study indicate that 46% of the diagnostic kits reported to be used in the proficiency testing program at ControlLab - Biochemistry are produced in Brazil, which demonstrates the importance of the national industry. However, with respect to metrological traceability, 14% of the 121 diagnostic kits surveyed did not inform about metrological traceability, and all of them were manufactured in Brazil. This suggests that some Brazilian manufacturers are not attentive to the dissemination of metrological traceability information as a means of attesting to the quality of their product. |
publishDate |
2015 |
dc.date.none.fl_str_mv |
2015-11-27 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Peer-reviewed article" "Artículo revisado por pares" "Artigo avaliado pelos pares" |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/531 10.3395/2317-269x.00531 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/531 |
identifier_str_mv |
10.3395/2317-269x.00531 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/531/258 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by-nc-nd/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by-nc-nd/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
dc.source.none.fl_str_mv |
Health Surveillance under Debate: Society, Science & Technology ; Vol. 3 No. 4 (2015): November; 68-73 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 3 Núm. 4 (2015): Noviembre; 68-73 Vigil Sanit Debate, Rio de Janeiro; v. 3 n. 4 (2015): Novembro; 68-73 2317-269X reponame:Vigilância Sanitária em Debate instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
Vigilância Sanitária em Debate |
collection |
Vigilância Sanitária em Debate |
repository.name.fl_str_mv |
Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br |
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1797042044198191104 |