1. Wade K. Aldous, Ph.D. LTC, USA Edgie-Mark Co, Ph.D., M(ASCP), CPT, USA Edward Keen, Ph.D., M(ASCP), CPT USA

2.  The 10 th Combat Support Hospital (CSH) is a level III medical facility that provides care to military coalition forces, US DoD civilians, contractors and host nationals.  The unit is augmented with a N403 Microbiology- Laboratory Augmentation set, as well as the Joint Biological Agent and Identification System (JBAIDS).

3.  Field-hardened air thermocycler capable of automated sample analysis for the presence of targeted DNA sequences for the following pathogens ◦ Anthrax ◦ Plague ◦ Tularemia (“Rabbit Fever”) ◦ Q fever ◦ Brucellosis ◦ WE and VE Encephalitis ◦ E. coli O157:H7

4.  Currently, the instrument is Diagnostic for the identification of Anthrax, Plague and Tularemia.  Only surveillance kits available for all others  Typical TAT for an assay: 3 to 5 hours

5.  Q fever caused by Coxiella burnetti  Causes unexplained fevers, chills, atypical pneumonias, commonly diagnosed as “fever of unknown origin”  Literature indicates that endemic in Iraq  Gold standard for detection is serology, but takes several months for diagnosis  H1N1 is a novel swine- like influenza virus  WHO declared H1N1 as a world-wide epidemic  Gold standard for detection and diagnosis is viral culture, but molecular tools are also available

6.  Human use protocol # MNC-IRAQ-08-003  Two red top and 2 blue top tubes collected, sera and plasma sent for serology to USAFSAM  JBAIDS assay requires only 800  l of sample

7.  Sample Size = 17  JBAIDS compared to serology ◦ Sensitivity = 67% ◦ Specificity = 100%  Convalescent serology used as the gold standard

8.  Reagent availability in theater  Contamination issues ◦ Dust? ◦ Positive control?  Training/trouble-shooting

9.  Emergency Use Authorization (EUA)  Test (mostly) Rapid Antigen test (RAT) positive samples  Sample requirements ◦ Nasopharyngeal Swabs (NPS) in Viral or Universal Transport Media ◦ Requires 600  l of transport media

10.  Sample size = 96  RAT sensitivity and specificity to H1N1 compared to RT-PCR ◦ Sensitivity = 100% ◦ Specificity = 22%

11.  Reagent availability in theater  Extremely technical  Training/trouble-shooting  Low throughput- only 4 samples per run ◦ Should all negatives be run due to low specificity?

12.  JBAIDS is a proven platform for the detection of particular pathogens  Validate and fast-track assay FDA-approval for other assays already fielded for instrument (i.e Q fever)  Develop assays for non-biothreat, but endemic pathogens such as malaria and leishmaniasis