Evaluación de las guías EP10-A2 y EP15-A2 de la CLSI para verificar el desempeño analítico de métodos cuantitativos
Fecha
2016
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Universidad de Guayaquil. Facultad de Ciencias Químicas
Resumen
Uno de los requerimientos establecidos dentro las normativas de acreditación internacional, relacionado con el aseguramiento de la calidad analítica, es la demostración de la validez de los métodos implementados en los laboratorios de análisis clínicos, para asegurar su desempeño en base a requisitos de fabricante, o a objetivos de calidad analítica. El CLSI de los Estados Unidos, cuenta con dos normativas para este fin: la EP10A2 y la EP15 A2. Se realizó un estudio descriptivo experimental con el fin de establecer el grado de concordancia en términos de aceptación para validación de métodos cuantitativos, empleando ambas normativas en paralelo para analitos de Química (n=10) e Inmunoquímica (n=10) seleccionados, en las instalaciones de Netlab S.A.(Quito).Una vez aplicados los protocolos, se determinó que el 100% de los analitos, independiente de la norma usada, muestran desempeño adecuado frente a objetivos de calidad analítica tanto en precisión, veracidad y error total, con una concordancia del 100%. Se concluye que la aplicación de los protocolos EP15 A2 y EP10 A2, permite la validación de métodos cuantitativos, trazados a objetivos de calidad analítica, lo que aporta evidencia objetiva de cumplimiento del requisito 5.5.2 de la norma ISO 15189, demostrando el uso previsto del método por un lado trazado a objetivos de calidad analítica.
One of the requirements established in the regulations of international accreditation, related to the assurance of analytical quality, is the demonstration of the validity of the methods implemented in clinical laboratories, to ensure its performance based on requirements manufacturer, or analytical quality goals. The US CLSI has two rules for this purpose: the EP10A2 and EP15 A2.An experimental descriptive study was conducted in order to establish the degree of consistency in terms of acceptance for validation of quantitative methods, using both standards in parallel for analytes Chemistry (n = 10) and Immunochemistry (n = 10) selected in the facilities Netlab SA (Quito).Once applied protocols, it was determined that 100% of the analytes, regardless of the standard used, show adequate performance against targets analytical quality in precision, accuracy and total error, with 100% agreement. It is concluded that the implementation of the protocols EP15 and EP10 A2 A2, allows the validation of quantitative methods, analytical paths to objectives of quality and performance stated by the manufacturer, which provides objective evidence of compliance with the requirement 5.5.2 of ISO 15189, showing the intended use of the method for trace analytical quality objectives on the other side and the performance declared by the manufacturer.
One of the requirements established in the regulations of international accreditation, related to the assurance of analytical quality, is the demonstration of the validity of the methods implemented in clinical laboratories, to ensure its performance based on requirements manufacturer, or analytical quality goals. The US CLSI has two rules for this purpose: the EP10A2 and EP15 A2.An experimental descriptive study was conducted in order to establish the degree of consistency in terms of acceptance for validation of quantitative methods, using both standards in parallel for analytes Chemistry (n = 10) and Immunochemistry (n = 10) selected in the facilities Netlab SA (Quito).Once applied protocols, it was determined that 100% of the analytes, regardless of the standard used, show adequate performance against targets analytical quality in precision, accuracy and total error, with 100% agreement. It is concluded that the implementation of the protocols EP15 and EP10 A2 A2, allows the validation of quantitative methods, analytical paths to objectives of quality and performance stated by the manufacturer, which provides objective evidence of compliance with the requirement 5.5.2 of ISO 15189, showing the intended use of the method for trace analytical quality objectives on the other side and the performance declared by the manufacturer.
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VALIDACIÓN, VERIFICACIÓN, PRECISIÓN, VERACIDAD, EP15-A2, EP10-A2, CLSI