scope:

INTRODUCTION

This document, in accord with NCCLS policies and guidelines, is an attempt to establish uniform descriptions for materials used in immunodiagnostic techniques based on agglutination. These regularized descriptions should be of interest to reagent producers and users.

Some characteristics of antibodies appropriate for agglutination reactions are defined. These characteristics include specificity, potency, labeling, and stability. Descriptions of methodology, limitations, and clinical validation are also addressed.

All terms used in this document are defined in the NCCLS document DI1-A2, Glossary and Guidelines for Immunodiagnostic Procedures, Reagents, and Reference Materials - Second Edition; Approved Guideline.