Eight Steps to Method Validation in a Clinical Diagnostic Laboratory

Abstract

Method validation is utilized to confirm that a test procedure for an analyte yields accurate and precise results. In this article, hemoglobin A1C is used as an example to demonstrate the process of a method validation; the performance of the Siemens Dimension Vista 1500 (new method) was compared to the Integra 800 Roche Modular System (old method). There are eight essential components for method validation: stating the primary objectives, listing the known variables, applying statistics, clarifying the analyte involved, selecting samples, explaining the methods used, performing data analysis, and explaining the results. These steps are critical for an analytical method validation procedure and are required in order to use a new assay for the clinical diagnosis of a patient.