Rastreabilidade metrológica no laboratório de análises clínicas

• Autor(a) principal: Pessoa, Maria Cristina Ferreira
• Data de Publicação: 2015
• Tipo de documento: Dissertação
• Idioma: por
• Título da fonte: Biblioteca Digital de Teses e Dissertações da UERJ
• Texto Completo: http://www.bdtd.uerj.br/handle/1/15010
• topic: Metrological traceability; Clinical laboratory; Reference material; Certified reference material; Reference methods; Rastreabilidade metrológica; Análises clinicas; Material de referência; Material de referência certificado; Método de referência; Laboratórios médicos Controle de qualidade; Tecnologia de laboratórios médicos Controle de qualidade; Laboratórios médicos Confiabilidade; Laboratórios médicos Medição; Instrumentos de medição Confiabilidade; CNPQ::CIENCIAS DA SAUDE::MEDICINA

The importance of metrological traceability in the manufacture of kits (diagnostic kits) is not well understood in the laboratory community and therefore its influence on method validation and the production of accurate and comparable results in clinical laboratories is not discussed. This study aims to contribute to the dissemination of this knowledge and emphasizes the importance of using diagnostic kits that have used Certified Reference Material or Reference Method during its manufacture. This study was done with the information provides on metrological traceability by diagnostic companies and the performance analysis of the diagnostic kits of glucose, urea, creatinina, uric acid and cholesterol with the resultas obtained in a proficiency testing program throughout 2012 and 2013. According to the study, the metrological traceability was exclusively demonstrated in 57% cases by the use of MRC and in 26% by the use of reference method. For the diagnostic kits that used MRCs during its manufacturing process, the MRC was sourced exclusively in the National Institute of Standards & Technology (NIST). The results of the study indicate that 46% of the diagnostic kits reported in the proficiency testing program from ControlLab - BiochemistryI are produced in Brazil, which demonstrates the importance of the national industry in the Brazilian market. However, with regard to metrological traceability, among 121 diagnostic kits surveyed, 14% do not inform metrological traceability and all of them are manufactured in Brazil, suggesting that there are manufacturers that are not attentive to the dissemination of this information as a means of attest the quality of their product. The performance analysis conducted to verify if there was difference between the results of measurements at the use or not of CRM or Reference method in manufacture of diagnostic kits, evidenced that results originated from diagnostic kits that use reference methods in manufacturer process have higher accuracy. The lowest difference is observed between diagnostics kits that use MRC and Reference methods. This demonstrate that the results are better comparable when the analytical system has metrological traceability. When we studied the difference found in values in the reference (normal) range of creatinina and uric acid, was observed that is significant and can interfere in the clinical interpretation. Therefore, the knowledge of metrological traceability and its influence at production more accurate results, will enable to the laboratory choose the analytical systems more suitable for use in routine laboratorial. And it will offer to the medical community more harmonized results.