Recommendations for reducing response time to foreign animal disease in the United States with point-of-care diagnostic tests.

Objective: Foreign animal diseases (FADs) are nonnative to the US and threaten animal welfare and economy. During FAD outbreaks, reliance solely on laboratory-based tests challenges response due to cost and turnaround time. Validated point-of-care (POC) diagnostic tests enable early field detection, reduce economic impact, and protect animal welfare. This proposal recommends a national POC diagnostic testing framework for FADs, providing guidance on modifying existing tests and serving as a resource for laboratory diagnosticians.

Methods: In 2022, at the American Association of Veterinary Laboratory Diagnosticians annual meeting, the National Animal Health Laboratory Network (NAHLN) Laboratory Directors Committee evaluated a draft POC testing process. In 2023, 27 stakeholders, including regulatory agencies, industry stakeholders, and diagnostic laboratories from 8 states, evaluated the draft process for distribution, use, and reporting and provided recommendations for validating POC testing.

Results: The 6 steps of the POC testing framework were validated by 27 stakeholders. Recommendations for improving FAD response were submitted to the USDA APHIS Veterinary Services and NAHLN, focusing on validation, importation, licensing, test validity, deployment, communication of results, animal movement, and indemnity.

Conclusions: Through stakeholder evaluation of testing framework, recommendations were provided to the USDA APHIS Veterinary Services and NAHLN for validating each step of POC testing framework, thereby reducing detection and response times during FAD outbreaks while making it cost efficient for producers and public. However, test performance and human behavior should be thoroughly evaluated to reduce variability of results.

Clinical relevance: Point-of-care testing to enable quick and cost-effective FAD response, rapid containment, reduced disease transmission, and improved efficiency motivated the development of a stakeholder-informed revision to the testing framework through qualitative evaluation and expert recommendations.