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Thermo Fisher Scientific - Calvin Gunter

Calvin Gunter

Senior Manager, Product Management Thermo Fisher Scientific

Why is USDA licensing of diagnostic kits important and who regulates it?

The US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) regulates veterinary biologics, which includes diagnostic kits, vaccines, bacterins, antisera and other products of biological origin, to ensure that the veterinary biologics available for the diagnosis, prevention and treatment of animal diseases are pure, safe, potent and effective. This work is done by APHIS’ Center for Veterinary Biologics (CVB). USDA licensed kits deliver accurate and actionable test results to veterinarians and producers that help them to limit the economic impact of disease.

What is the regulatory scope for USDA licensing?

Regulatory Scope

While the sample preparation products, instruments and software are not regulated, the test kits themselves are regulated by APHIS. However, it’s much bigger than just the kits. The three focus areas for USDA licensing approval include criteria of the production facility, test kit performance and test kit production and commercialization.

At the production facility, each diagnostic kit production must follow a serial release platform similar to vaccines. Also, any adverse effects with the kit, meaning kit performance is less than data indicates, must be reported to USDA.

Test kit performance regulations involve a kit’s sensitivity and specificity, or the efficacy and effectiveness of the assay to specifically identify a pathogen and the sensitivity of finding that pathogen within the sample. Real-time PCR has changed the diagnostics industry because it offers significantly greater sensitivity and specificity than culture.

Test kit performance

Field repeatability and reproducibility involve testing at three locations and with three different lots to create consistency of results when utilizing the kit. Analytical studies are conducted to show limit of detection, inclusiveness and exclusivity. Stability work is also conducted on assays, which can sometimes result in an extended expiration date.

Test kit production and commercialization including an outline of production which is similar to a contract with USDA that describes how the test kit will be manufactured. It explains the intended use of the test kit, for example, detecting detection and distinction of animals that are persistently or acutely infected with bovine viral diarrhea virus in cattle. It also includes the standardization and validation of the manufacturing process, the serial release criteria, kit configuration and product insert and labeling.

When complete, Thermo Fisher Scientific is provided two approval documents:

USDA
  1. USDA approval of this facility to manufacture the biological
  2. USDA approval of the kit as a registered diagnostic tool

Across all three focus areas, there’s a significant level of scrutiny with USDA licensed kits that is not applied to non-USDA licensed reagents.

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