The Joint Biological Agent Identification and Diagnostic System (JBAIDS) and Entomology

1. The Joint Biological Agent Identification and Diagnostic System (JBAIDS) and Entomology Major Jamie Blow USAMRIID

2. History Entomologists recognize the need to be able to test the arthropods they collected during surveillance for the presence of endemic and enzootic diseases. The fielding of various diagnostic capabilities to test arthropods for pathogens has enhanced our ability to conduct a more accurate risk assessment. However, diagnostic capabilities are rapidly evolving, producing faster and better platforms and methodologies based on new technological advances.

3. Existing Entomological Field Diagnostic Capabilities • Wicking Assays • LTC Russell Coleman • LTC Jeff Ryan • Field Exportable PCR • LTC Monica O’Guinn • Dr. John Lee • Fluorogenic PCR • AFIOH • CHPPM • WRAIR • USAMRIID

4. Joint Biological Agent Identification and Diagnostic System (JBAIDS) ORD During Operation Desert Storm, a major deficiency identified was the inability of U.S. forces to effectively defend against biological warfare (BW) and other biological agents of operational concern. Current national military strategy specifies a worldwide force-projection capability that requires identification, diagnosis, and vaccination to protect U.S. forces against potential biological threats. Reliance on traditional laboratory methods, located in rear or CONUS locations, did not provide timely information needed for force health protection. Thus, the need for this capability was identified resulting in the JBAIDS ORD.

5. JBAIDS System Definition • Simultaneously identify BW agents, infectious disease agents, and toxins. • Specifically identify BW agents to prevent exposure or to promptly initiate agent-specific treatment. • ID agents within 60 minutes or less from time of sample receipt. • Have dual use for either clinical or environmental samples. • User: USA, USN, USMC, USAF

6. JBAIDS Mission Description The JBAIDS is a reusable, portable, modifiable, biological agent identification and diagnostic system capable of simultaneous reliable identification of multiple biological agents of operational concern and other pathogens of clinical significance. • JBAIDS will augment and integrate with existing medical biological identification systems to provide a comprehensive identification and diagnostic capability. • JBAIDS will enhance force protection by providing commanders and medical personnel the capability to determine appropriate treatment, effective preventive measures, and prophylaxis, in response to the presence of BW agents.

7. JBAIDS Mission Description (continued) • JBAIDS will be configured to support reliable, fast, and specific identification of biological agents from a variety of clinical sources (blood, urine, feces, sputum, etc) and preventive medicine samples. • JBAIDS (Army) will be deployed at Army Medical Labs at the Division, Corps, and Echelons above Corps level. • JBAIDS (Air Force) will be deployed to each Air Force installation in a High Threat area. It will also be deployed with rapid-deployment security personnel. JBAIDS (Marine Corps) will be deployed to surgical companies in support of operational forces. • JBAIDS (Navy) will be deployed on ships and to each installation in a High Threat area. It will also be deployed with specialized rapid-deployment security personnel.

8. JBAIDS System Description • JBAIDS will be DoD’s first ruggedized medical warfare BW diagnostic system. • ACAT III with DOT&E oversight. • Joint Service Program with AFOTEC lead for T&E. • JBAIDS is a blocked acquisition plan. • Selected JBAIDS contractor is Idaho Technology and the platform will be a modified “Ruggedized Advanced Pathogen Identification Device (RAPID)”.

9. RAPID in the Field

10. JBAIDS System Description (continued) - Block 1 will identify (10 [T]; 20 [O]) Biological Warfare agents, and pathogens of operational significance, leverage current technologies, and will operate in Army Medical Labs at Division, Corps and Echelons of Corps. - Block II consists of the production of a new capability or modification of Block I to identify (5) toxins and an increased number of agents with increased sensitivity and reliability. - Block III will integrate all these capabilities into an integrated hand-held component with an increased automated sampling preparation, thus reducing overall processing time and reporting procedures.

11. JBAIDS System Description (Block I) • Block I will consist of production of the analytical device, device consumables, and protocols for identifying 10 biological warfare agents (BW) and biological agents of operational significance (excluding toxins). • Software package will include automatic specimen results analysis. Block I uses are 1) adjunct to clinical diagnosis, 2) forensic activities, 3) environmental sampling activities (water, food, entomology, veterinary and bio-detectors), and 4) medical surveillance.

12. Anthrax Brucella Ebola-Marburg Encephalitis VEE/EEE/WEE Glanders Plague Q Fever Smallpox Tularemia Typhus Cholera CCHF Cryptosporidium Dengue fever Escherichia coli Hantaan Influenza RVF Salmonella Shigella Block I Agents

13. JBAIDS System Description (Block II & III) • Block II will consist of production of a new capability to identify 5 toxins. This new capability may be accomplished by improvements/modifications to the existing device or development of new technology. • Block III consists of supplementation or replacement of the Block I and Block II devices by a fully integrated and automated specimen processing and analysis capability for confirmation of BW agents and biological agents of operational significance

14. Entomology and JBAIDS • Multiple BW and infectious disease pathogens of military concern are arthropod-borne (e.g., EEE/WEE/VEE, Plague, Dengue, RVF, CCHF) • Development of assays for detecting pathogens in the vector (environmental samples) will allow entomology to capitalize on developing technology that is being implemented across the DOD. • Identifying pathogens in vectors will provide information for implementing control measures.

15. JBAIDS in the Field • WRAIR, USAMRIID, AFIOH, and CHPPM are working together to develop and test primer/probe sets for detecting arthropod-borne diseases in the field. • RAPID and selected assays have been field tested in Honduras,Thailand, and Iraq.

16. Entomology and RAPID • Assay times are 45-90 minutes (to include RT step) • Development of assays • Extraction protocols • Development of validation criteria and panels to test assays against (in coordination with Critical Reagents Program/JBAIDS Program efforts).

17. Dengue 1-4 serotypes Dengue Universal West Nile virus JE VEE/WEE/EEE/SLE CCHF Yellow fever Leishmania general Karshi Hantaan Rickettsia rickettsia Leishmania donovani complex (visceral) Ae. aegypti L. paptasi P. sergenti RAPID Assays Under development

18. Current Entomology Issues • Extraction of RNA/DNA from arthropod samples • Nucleic acid stabilization • Pathogen inactivation • Reaction interference due to excess arthropod tissue, enzymes, and environmental contaminates.

19. Future Entomology Issues • More rapid extraction methods with no hazardous materials. • Dried down, pre-packaged reagents requiring little to no special handling. • Automated sample preparation in a closed, hand-held disposable module. • Development of more assays for selected pathogens.

20. JPEO-CBD POCs:JBAIDS and CRP • LTC Harry Modrow, JPM Medical Identification and Therapeutics (MITS), (301) 619-8425 • Ms. Donna Boston, SM JBAIDS, 301-619-8472 • Dr Peter Emanuel, CRP Director, 410-436-5562 ECBC Office

21. Air Force COL James Swaby LTC Debra Niemeyer LTC John Putnam MAJ Dan Atchley MAJ David Bowles CPT Keith Blount Mr. James McAvin Army LTC Russell Coleman LTC(P) Scott Gordon LTC James Jones Dr. Sofi Ibrahim Dr. Miguel Quintana Dr. Michael Turell Dr. Christopher Mores Acknowledgements