Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline
|Publication Date:||1 June 2012|
This document provides guidelines for the evaluation and verification of detection capability claims of clinical laboratory measurement procedures (ie, limit of blank [LoB], limit of detection [LoD], and limit of quantitation [LoQ]), as well as for their proper use, documentation, and interpretation. This guidance is suitable both for commercial products as well as laboratory-developed
The intended users of this guideline are manufacturers of in vitro diagnostic (IVD) reagents, regulatory bodies, and clinical laboratory personnel.