Veterinary Diagnostics in the United States
In the United States, certain veterinary diagnostics are regulated and require approval by the United States Department of Agriculature – Center for Veterinary Biologics (USDA-CVB). These include veterinary diagnostic kits intended to diagnose pathogens or a patient’s immune status and which are sold as complete kits to veterinarians. Examples of veterinary diagnostics which are regulated by the USDA-CVB are point-of-care diagnostics such as those to test for feline leukemia virus, canine parvovirus, canine heartworm, and other viruses, bacteria, parasites and veterinary pathogens.
The USDA-CVB does not regulate individual reagents or test kits not claiming to detect or diagnose the existence of, or susceptibility to, potential disease causing agents in animals (e.g. bacterial typing tests or those which measure metabolic biomarkers). The USDA-CVB does not endorse or regulate veterinary diagnostic tests which are developed and used in house, such as tests available through veterinary reference diagnostic laboratories.
Veterinary Medical Devices
Veterinary Genetic Tests
Veterinary Diagnostic Market Segments
The veterinary diagnostic market can be categorized several different ways, including:
- In house clinical chemistry and blood analysis equipment
- In house infectious disease immunodiagnostics (reagents, assays and test kits)
- Non-infectious disease diagnostic kits and equipment which can be used for analysis of hormones, immune function, and biomarkers.
- Molecular diagnostics kits such as PCR, or genetic analysis for specific hereditary diseases.
- Other testing reagents for use in histology (immuno-histochemistry, staining, etc.).
- Microbiology kits such as growth plates (agars, etc.)
- HPLC, MS, GC, and MALDI-TOF for proteomics and bioanalysis of biological samples (blood, etc.)
More information concerning the requirements for licensing a veterinary diagnostic can be found at the USDA-APHIS website (click here).
Regulated Veterinary Diagnostics (Veterinary Diagnostic Kits)
Diagnostic kits which require approval must be validated by evidencing diagnostic accuracy. Certain aspects required for approval may consist of:
- Analytical sensitivity – limit of detection
- Analytical specificity
- Cutoff value
- Inter-laboratory comparison