Metrological traceability in laboratory medicine: study of biochemistry kits used in clinical pathology laboratories

• Autor(a) principal: Pessoa, Maria Cristina Ferreira
• Data de Publicação: 2015
• Outros Autores: Ferreira Jr., Orlando Costa
• 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
• 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

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.