scope:

INTRODUCTION

The definitions, information, and procedures necessary to properly assess the quality of radioimmunoassay systems are described. Awareness of the evaluation process allows laboratory personnel to better assess systems that meet the specific needs of the patient population.

This guideline may serve as a companion document to the Food and Drug Administration (FDA) regulation, "In Vitro Diagnostic Products for Human Use^"1 (see the appendix). It is intended to include all assay systems that use receptors that function like antibodies, e.g., intrinsic factor for vitamin B-12 and thyroxine-binding globulin for thyroid hormones.