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Wade K. Aldous, Ph.D. LTC, USAEdgie-Mark Co, Ph.D., M(ASCP), CPT, USA
Edward Keen, Ph.D., M(ASCP), CPT USA
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The 10th 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).
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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
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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
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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
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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
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Sample Size = 17 JBAIDS compared to serology
◦ Sensitivity = 67%◦ Specificity = 100%
Convalescent serology used as the gold standard
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Reagent availability in theater
Contamination issues◦ Dust?◦ Positive control?
Training/trouble-shooting
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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
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Sample size = 96 RAT sensitivity and specificity to H1N1
compared to RT-PCR◦ Sensitivity = 100%◦ Specificity = 22%
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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?
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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