Procedimiento de verificación analítica basado en CLSI EP15-A3 y construcción de carta de control para la determinación de cistatina C en el sistema de Nefelometría Atellica® NEPH630 realizado en el Laboratorio Clínico Diagnomed S.A.
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Date
2024
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Universidad de Concepción
Abstract
La creatinina, el principal biomarcador para la Insuficiencia Renal Aguda (IRA), presenta limitaciones por su variabilidad según la edad, dieta o masa muscular del paciente. En este contexto, la cistatina C emerge como una alternativa prometedora. Esta proteína, de bajo peso molecular y producción constante, no se ve afectada por los factores mencionados. Se filtra libremente en el glomérulo y se reabsorbe y cataboliza en el túbulo proximal, sin reingresar al torrente sanguíneo. Su principal ventaja radica en su capacidad de aumentar de 36 a 48 horas antes que la creatinina en la IRA, permitiendo un diagnóstico más precoz, crucial en la población pediátrica por las potenciales secuelas a largo plazo. En este estudio, se verificó con éxito la determinación de cistatina C en el sistema Atellica® NEPH630 del Laboratorio Clínico Diagnomed S.A., siguiendo el protocolo EP15-A3 del CLSI para la evaluación de la imprecisión y sesgo de los datos. Esta verificación abre la puerta a la puesta en marcha de la medida de la cistatina C como un biomarcador más preciso y temprano para la IRA, especialmente en la población pediátrica, mejorando la calidad del diagnóstico y el pronóstico de la enfermedad.
Creatinine, the main biomarker for Acute Kidney Injury (AKI), has limitations due to its variability depending on the patient's age, diet or muscle mass. In this context, cystatin C emerges as a promising alternative. This protein, with a low molecular weight and constant production, is not affected by the aforementioned characteristics. It is freely filtered in the glomerulus and reabsorbed and catabolised in the proximal tubule, without re-entering the bloodstream. Its main advantage lies in its ability to rise 36 to 48 hours earlier than creatinine in AKI, allowing early diagnosis, which is crucial in the paediatric population because of the potential long-term sequelae. In this study, cystatin C determination was successfully verified on the Atellica® NEPH630 system of Laboratorio Clínico Diagnomed S.A., following the CLSI EP15-A3 protocol for the evaluation of data imprecision and bias. This verification opens the door to the implementation of cystatin C as a more accurate and earlier biomarker for AKI, especially in the paediatric population, improving the quality of diagnosis and prognosis of the disease.
Creatinine, the main biomarker for Acute Kidney Injury (AKI), has limitations due to its variability depending on the patient's age, diet or muscle mass. In this context, cystatin C emerges as a promising alternative. This protein, with a low molecular weight and constant production, is not affected by the aforementioned characteristics. It is freely filtered in the glomerulus and reabsorbed and catabolised in the proximal tubule, without re-entering the bloodstream. Its main advantage lies in its ability to rise 36 to 48 hours earlier than creatinine in AKI, allowing early diagnosis, which is crucial in the paediatric population because of the potential long-term sequelae. In this study, cystatin C determination was successfully verified on the Atellica® NEPH630 system of Laboratorio Clínico Diagnomed S.A., following the CLSI EP15-A3 protocol for the evaluation of data imprecision and bias. This verification opens the door to the implementation of cystatin C as a more accurate and earlier biomarker for AKI, especially in the paediatric population, improving the quality of diagnosis and prognosis of the disease.
Description
Tesis presentada para optar al título de Bioquímico/a.
Keywords
Insuficiencia Renal, Creatinina, Cistatina C, Biomarcadores