Procedimiento de verificación analítica basada en CLSI EP15-A3 y análisis de desempeño para la determinación de cobre en el sistema automatizado Atellica CH 930 realizado en el laboratorio clínico Diagnomed S.A..
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Date
2022
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Publisher
Universidad de Concepción
Abstract
La verificación del rendimiento analítico del método por el cual son determinados distintos analitos en el laboratorio clínico es un requisito esencial para el análisis de muestras de pacientes. En este trabajo el objetivo fue Implementar la determinación de cobre mediante el ensayo Copper de Sentinel Diagnostics por método colorimétrico en el sistema automatizado Atellica CH 930, usado en el laboratorio clínico DIAGNOMED Para ello se verificó el rendimiento de la determinación de cobre mediante un método colorimétrico en el sistema automatizado Atellica CH930 en el Laboratorio Clínico Diagnomed S.A frente a las afirmaciones indicadas por el fabricante (Sentinel Diagnostics) utilizando las directrices del protocolo CLSI EP15-A3. El estudio fue realizado utilizando 3 niveles de control de calidad de tercera opinión de BioRad®. Se estableció la configuración de ensayos de canal abierto de la determinación de cobre en el sistema automatizado Atellica CH930 y posteriormente se llevó a cabo el estudio de verificación de la precisión y estimación del sesgo de la técnica utilizando cinco repeticiones de control de calidad por cada nivel de control durante cinco días. Con los resultados obtenidos se calcularon las estimaciones de imprecisión en forma de coeficiente de variación y fueron comparadas con las afirmaciones del fabricante siendo aceptada la verificación de la precisión y se estableció un requisito de calidad siendo mediante este aceptada la verificación de la estimación de sesgo. Finalmente se realizó un análisis de desempeño mediante un programa de calidad externo mediante el cual se obtuvo un rendimiento analítico bueno.
Verification of the analytical performance of the method by which distinct analytes are determined in the clinical laboratory is an essential requirement for the analysis of patient samples. In this study, the performance of copper determination by a colorimetric method in the Atellica CH930 system at "Laboratorio Clínico Diagnomed S.A" was verified against the statements indicated by the manufacturer (Sentinel Diagnostics) using the guidelines of the CLSI EP15-A3 protocol. The study was performed using 3 levels of BioRad® quality control. The configuration of open channel assays for the determination of copper was established in the Atellica CH930 system and then the study of verification of the precision of the technique was carried out using five repetitions of quality control for each level of control for five days. With the results obtained, the imprecision estimates were calculated in the form of a coefficient of variation and were compared with the manufacturer's statements, the verification of the precision was accepted, and a quality requirement was established, through which the verification of the Bias estimate was accepted. Finally, a performance analysis was carried out through an external quality program through which a good analytical performance was obtained.
Verification of the analytical performance of the method by which distinct analytes are determined in the clinical laboratory is an essential requirement for the analysis of patient samples. In this study, the performance of copper determination by a colorimetric method in the Atellica CH930 system at "Laboratorio Clínico Diagnomed S.A" was verified against the statements indicated by the manufacturer (Sentinel Diagnostics) using the guidelines of the CLSI EP15-A3 protocol. The study was performed using 3 levels of BioRad® quality control. The configuration of open channel assays for the determination of copper was established in the Atellica CH930 system and then the study of verification of the precision of the technique was carried out using five repetitions of quality control for each level of control for five days. With the results obtained, the imprecision estimates were calculated in the form of a coefficient of variation and were compared with the manufacturer's statements, the verification of the precision was accepted, and a quality requirement was established, through which the verification of the Bias estimate was accepted. Finally, a performance analysis was carried out through an external quality program through which a good analytical performance was obtained.
Description
Tesis presentada para optar al título de Bioquímico/a.
Keywords
Cobre, Homeostasis, Ensayo