Metrological traceability in clinical laboratory

Abstract

ABSTRACT Introduction: Metrological traceability is a little-known and little-discussed metrology theme in clinical laboratories, although it is the basis for comparable results. It is associated with certified reference material (CRM) and reference method (RMet). When it is used in the supply chain by diagnostic kit manufacturers, it ensures accuracy of the results yielded by laboratories. Objective: This study shows the availability of information on metrological traceability provided by diagnostic kit manufacturers. Method: It was done with the information obtained in kits of glucose, urea, creatinine, uric acid and cholesterol participants in a proficiency testing program throughout 2012 and 2013. Results and conclusion: In the research, 18 producers of reference materials (RMs) and 204 measurands available for laboratory medicine were found. In the study of metrological traceability, the preferential use of CRM was demonstrated by kit manufacturers (glucose 60%, urea 69%, creatinine 60%, uric acid 50%, and cholesterol 43%). An important factor is that there are a significant number of kits that do not report traceability (glucose 16%, urea 19%, creatinine 16%, uric acid 13%, and cholesterol 5%), although it is a requirement for product registration in Brazil. We hope that this study will contribute to sensitize the laboratory community to the need for a more comprehensive knowledge of this subject, and that it will stimulate institutions involved in the dissemination of knowledge in laboratory medicine to hold discussions on this topic.

Keywords

• reagentes de laboratório
• bioquímica