Contenido principal del artículo

Equivalence of results issued by clinical laboratories can be achieved by standardization or harmonization. The generation of comparable results allows common reference intervals between laboratories using different measurement procedures and materials for calibration and trueness control. The aim of this article is to describe the state of the art of metrological traceability in laboratory medicine, currently highlighted through the guidelines of ISO 17511, which in its 2020 version, shows six different hierarchical alternatives, ranging from comparability to certified reference materials and reference measurement procedures, to traceability only to the manufacturer. This new version of 17511 adds the possibility to demonstrate traceability to international harmonization protocols. Demonstrating metrological traceability is required to achieve ISO 15189 accreditation for clinical laboratories. To achieve equivalence of measurements in laboratory medicine, it is desirable to bring clinical laboratory professionals closer to the metrological language and the stakeholders involved.

Quintana-Ponce, S. (2022). El estado del arte de la trazabilidad metrológica en la Medicina de Laboratorio. Revista De Ciencias, 25(1), e11676. https://doi.org/10.25100/rc.v25i1.11676

Miller WG y Greenberg N. (2021). Harmonization and standardization: Where Are We Now?, The Journal of Applied Laboratory Medicine, 6 (2): 510-521. https://doi.org/10.1093/jalm/jfaa189

Deirdre L. C., y Naugler C. (2019). Benefits and risk of standardization, harmonization and conformity to opinion in clinical laboratories. Critical Reviews in Clinical Laboratory Sciences, 56 (5): 287-306. https://doi.org/10.1080/10408363.2019.1615408

Beastall G.H., Nannette B., Quiroga S., Myers G., and prepared on behalf of the Joint Committee form Traceability in Laboratory Medicine. (2018). Traceability in laboratory medicine: what is it and why is it important for patients?. Clinical Chemistry and Laboratory Medicine. 29 (4): 242-247. https://doi.org/10.1515/cclm-2017-0060 ERROR DE DOI, este es el doi del trabajo referenciado en el #7

Ricós C., Fernández P., Marqués F., Minchinela J., Salas A., Martínez CB, et al. (2020). Impacto de la introducción de un programa externo de categoría 1 en la vigilancia de la estandarización entre laboratorios clínicos en España. Advances in Laboratory Medicine. 1 (1): 20200008.

https://doi.org/10.1515/almed-2020-0008

ISO 17511:2020. (2020). In vitro diagnostic medical devices-requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples, 2nd ed. Geneva (Switerland): ISO 2020. ISO 17511:2020(en), In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

Panteghini M y Braga F. (2020). Implementation of metrological traceability in laboratory medicine: where we are and waht is missin. Clinical Chemistry and Laboratory Medicine, 58 (8): 1200-1204.

https://doi.org/10.1515/cclm-2019-1128

Beastall G.H., Nannette B., Quiroga S., Myers G., and prepared on behalf of the Joint Committee form Traceability in Laboratory Medicine. (2017). Traceability in laboratory medicine: a global driver for accurate results for patient care. Clinical Chemistry and Laboratory Medicine, 55 (8): 1100-1108. https://doi.org/10.1515/cclm-2017-0060

Panteghini M y Braga F. (2020). Implementation of metrological traceability in laboratory medicine: where we are and waht is missin. Clinical Chemistry and Laboratory Medicine, 58 (8): 1200-1204.

https://doi.org/10.1515/cclm-2019-1128

Cobbaert C.M., Althaus H., Brkovic B., Ceglarek U., Coassin S., Delatour V., et al. (2021). Towards an SI Traceable Reference Measurement System for seven serum Apolipoproteins Usin Bottom-Up Quantitative Proteomics: Conceptual Approch Enabled by Cross-Disciplinary/Cross-Sector Collaboration. Clinical Chemistry, 67 (3): 478-489 https://doi.org/10.1093/clinchem/hvaa239

Centro Nacional de Metrología y Entidad Mexicana de Acreditación. (2015). Guía de Trazabilidad Metrológica de los Valores asignados a los Calibradores y Material de Control Empleados por el Laboratorio Clínico. México.

https://www.researchgate.net/publication/305489328_Guia_de_trazabilidad_metrologica_de_los_valores_asignados_a_los_calibradores_y_material_de_control_empleados_por_el_laboratorio_clinico/link/5791002d08ae64311c11a3b6/download

Plebani M. (2015). Harmonization in laboratory medicine: Requests, samples, measurements and reports, Critical Reviews in Clinical Laboratory Sciences, 53 (3): 184-196.

https://doi.org/10.3109/10408363.2015.1116851

Descargas

Los datos de descargas todavía no están disponibles.

Métricas

Cargando métricas ...