From Port-Side to Pen-Side: Low Cost Detection/Diagnostics for High-Consequence Transboundary or Nationally Reportable Animal Diseases, Particularly Those with Zoonotic Propensity

The economic value of the United States (U.S.) poultry industry is approximately $50 billion. Avian Influenza, Virulent New Castle Disease, and Marek's Disease are caused by viral pathogens that are highly contagious and pose the risk of significant economic impact to U.S. security. Likewise, the economic value of the pork and beef industries are approximately $39 billion and $77 billion, respectively. Nipah virus encephalitis, Classical and African swine fevers, Lumpy skin disease, and Bovine spongiform encephalopathy are just a few examples of infectious diseases that threaten pork and beef industry food security. As the world euphemistically shrinks, the risk of pathogens arriving in the U.S. is an ever-growing concern. Despite numerous efforts, significant gaps remain regarding detection/identification or medical countermeasures development to combat the etiological agents of these diseases. Development of diagnostics for these pathogens would serve to mitigate the risk of serious disease outbreaks by providing early warning, so that countermeasures may be put into place before the respective industry is severely damaged or irrecoverably affected. Zoonotic pathogens are microorganisms that are the main drivers for emerging (or re-emerging) infectious diseases in humans. Numerous wild and domestic animals serve as amplifying hosts for various viruses. Transmission to humans occurs through various mechanisms such as direct contact with animal fluids and secretions. The 2017 U.S. One Health Zoonotic Disease Prioritization workshop identified eight zoonotic diseases of concern including: zoonotic influenza, Salmonellosis, West Nile virus, Plague, emerging coronaviruses, Rabies, Lyme disease, and Brucellosis. Our lack of ability to detect certain high zoonotic propensity pathogens in a field forward environment represents a significant gap in homeland security. Reliable diagnostics for these pathogens would greatly reduce risk to the U.S. population by providing early detection and therefore additional time to employ countermeasures, both medical and physical, resulting in a dramatically reduced impact on society and human health. Worldwide, the high consequence transboundary animal pathogens of concern include those pathogens listed in the World Organisation for Animal Health - OIE lists A and/or B. At the U.S national level, reportable animal pathogens of concern include those listed in the United States Department of Agriculture (USDA) National Animal Health Reporting System (NAHRS) and/or CDC One Health Zoonotic Disease Prioritization (OHZDP) Process and its workshops. Of particular interest are those animal pathogens with high zoonotic potential, for one or more species considered critical domestic sources of protein (e.g., poultry, swine, cattle, etc.). The proposed technology must meet the following performance objectives: The ability to detect at least two transboundary or nationally reportable animal pathogens, including those with zoonotic potential in a sample specimen (blood, secretions, excretions, tissue, food/feed products, etc.) o Note: the use of non-pathogenic surrogates is sufficient for demonstration of proof-of-concept work Be field deployable for rapid diagnosis Produce results within 1 hour Detect directly from samples currently used in animal health, food safety, or environmental surveillance diagnostics Minimal to zero upfront sample preparation Per test costs for the multiplexed cartridges less than ~$50 and a reader/reporter cost less than $1,000 Quantitative or qualitative results are acceptable (e.g., copy/colony number vs. yes/no pathogen detected) Detection limit less than one log 10 less sensitive than the gold standard,' resulting in prediction conditions of correlating with at least 95% sensitivity and 95% specificity Electronic reporting of results in a secure manner A system capable of conducting point-of-care (e.g., pen-side or port-side) detection/diagnostics could greatly aid the USDA, Department of Health and Human Services (HHS), and Department of Homeland Security (DHS), as well as State, Local, Tribal, and Territorial (SLTT) personnel. The benefits of early detection and identification could include reducing manpower requirements and costs; improving human health and animal safety; and mitigating the overall risk to the homeland posed by pathogens and other materials of food, agriculture, and veterinary defense (FAVD) concern. This same strategy applies to pathogens that are suspected of having the capacity to initiate zoonotic events. Affordable diagnostics with a Clinical Laboratory Improvement Amendments (CLIA) waiver would place a powerful tool in the hands of Transportation Security Administration (TSA) agents, Customs and Border Protection (CBP) inspectors, USDA inspectors, and foreign animal disease diagnosticians surveying or intercepting food items that may be contaminated with these highly contagious animal pathogens. These diagnostics would be valuable to farmers/ranchers for animal feed sampling and surveillance and the potential identification of outbreaks in an early stage so that countermeasures could rapidly be put in place. First responders and medical institutions would also benefit from access to these tools.