Evaluación de las guías EP10-A2 y EP15-A2 de la CLSI para verificar el desempeño analítico de métodos cuantitativos

Abstract:

One of the requirements established in the regulations of international accbkp_reditation, 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.

Año de publicación:

2016

Keywords:

• VALIDACION
• CLSI
• EP15-A2
• Precision
• Verificación
• EP10-A2
• Veracidad

Fuente:

rraae