Control de calidad del material biológico humano recolectado con fines de investigación
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Universidad Industrial de Santander
Abstract
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El material biológico humano proporciona información valiosa sobre niveles de metabolitos asociados con el desarrollo de cierto tipo de enfermedades, por tanto es una herramienta importante para monitorear respuestas a tratamientos e incluso identiicar nuevos mecanismos de intervención. Los procedimientos a los que se expone el material biológico desde su obtención hasta su fase analítica, son denominados variables pre-analíticas, las cuales, pueden tener un efecto directo en la detección de metabolitos y por consiguiente sobre resultados de proyectos de investigación, en particular en ausencia de procesos estandarizados que garanticen el control de calidad del material biológico. La presente nota técnica tiene como inalidad resaltar algunos puntos críticos que deben ser parametrizados en las bio-colecciones con ines de investigación, para garantizar altos estándares de calidad y reproducibilidad en estudios observacionales, en donde se minimice cualquier tipo de sesgo ocasionado por las variables pre-analíticas. Así mismo, identiicar la importancia en el desarrollo de biobancos con ines de investigación en nuestro país para contar con material biológico humano de alta calidad.
Human biological material provides valuable information about levels of metabolites associated with the development of certain diseases, becoming an important tool for monitoring responses to treatment or even identifying new intervention mechanisms. The procedures to what the biological material are exposed from their preparation to their analytical phase are called pre-analytical variables, which can have a direct effect on the detection of metabolites, and therefore, on the results of the research projects, particularly in the absence of standardized processes that confirm the quality control of the biological material. This technical note highlights some critical points that must be parameterized in the biocollections for research purposes to ensure high standards of quality and reproducibility in observational studies, where any kind of bias caused by the pre-analytical variables is minimized. In addition, it is intended to identify the importance of the development of biobanks for research purposes in our country in order to have human biological material of high quality
Human biological material provides valuable information about levels of metabolites associated with the development of certain diseases, becoming an important tool for monitoring responses to treatment or even identifying new intervention mechanisms. The procedures to what the biological material are exposed from their preparation to their analytical phase are called pre-analytical variables, which can have a direct effect on the detection of metabolites, and therefore, on the results of the research projects, particularly in the absence of standardized processes that confirm the quality control of the biological material. This technical note highlights some critical points that must be parameterized in the biocollections for research purposes to ensure high standards of quality and reproducibility in observational studies, where any kind of bias caused by the pre-analytical variables is minimized. In addition, it is intended to identify the importance of the development of biobanks for research purposes in our country in order to have human biological material of high quality
Keywords
Biobank, biocollections, pre-analytical variable, metabolites, biomarkers, quality control, traceability, human biological material, Biobanco, bio-colecciones, variables pre-analíticas, metabolitos, biomarcadores, control de calidad, trazabilidad, material biológico humano