scope:

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 tests. It is particularly important for measurement procedures for which the associated measurand's medical decision level is low (ie, approaching zero).

The intended users of this guideline are manufacturers of in vitro diagnostic (IVD) reagents, regulatory bodies, and clinical laboratory personnel.