Presentation on theme: "Wade K. Aldous, Ph.D. LTC, USA Edgie-Mark Co, Ph.D., M(ASCP), CPT, USA Edward Keen, Ph.D., M(ASCP), CPT USA."— Presentation transcript:
Wade K. Aldous, Ph.D. LTC, USA Edgie-Mark Co, Ph.D., M(ASCP), CPT, USA Edward Keen, Ph.D., M(ASCP), CPT USA
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).
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
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
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
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
Sample Size = 17 JBAIDS compared to serology ◦ Sensitivity = 67% ◦ Specificity = 100% Convalescent serology used as the gold standard
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
Sample size = 96 RAT sensitivity and specificity to H1N1 compared to RT-PCR ◦ Sensitivity = 100% ◦ Specificity = 22%
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?
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