Regulatory control of veterinary diagnostic test kits.

ABSTRACT

Veterinary diagnostic test kits are used in clinical practice and production medicine as a basis for prescribing vaccination and/or treatment regimens. These kits are also used by state and federal animal health officials to control or regulate the movement of animals. The regulation of such kits, which generally takes the form of establishing requirements for licensure, ensures that the kits conform to minimum standards for sensitivity, specificity and reproducibility. To qualify for licensing, diagnostic test kits should have consistent performance characteristics.