Zamora PA

Language: Spanish
References: 5
Page: 180-185
PDF size: 66.51 Kb.

ABSTRACT

Two methods for the evaluation of imprecision are compared and discussed, EP15-A2 User Guide Verification of Performance for Precision and trueness, proposed by the CLSI (Clinical and Laboratory Standards Institute), formerly known as NCCLS, as well as the protocol published in the “Guide for Validation and Verification of Quantitative Examination Procedures Used by the Clinical Laboratory” published by (ema.ac) Mexican Accreditation Entity. We analyzed an exercise with each of the methods, outcome and acceptance criteria for each of the trials is discussed. With this simple explanation, the reader is expected to gather enough information in order to decide which method shall be used to evaluate staff performance within their analytical methods.

REFERENCES

1. Vocabulario Internacional de Metrología – Conceptos Fundamentales y Generales y Términos Asociados (VIM). Traducción al Español de VIM 3°. JCGM 200:2008.

2. Tholen D. CLSI EP Documents, CLSI evaluation protocols. August 2006. www.mlo.online.com (Acceso el 20 de Julio 2011).

3. Chesher D, Evaluating Assay Precision. Clin Biochem Rev 2008; 29 (suppl 1).

4. Clinical and Laboratory Standards Institute. User verification of performance for precision and trueness; approved guideline – second edition. CLSI document, EP15-A2. Wayne, PA, USA: CLSI; 2005.

5. Entidad Mexicana de Acreditación (EMA). Guía para la validación y la verificación de los procedimientos de examen cuantitativos empleados por el laboratorio clínico, publicada. México, Abril 2008.