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Molecular Capabilities in a Combat Support Hospital

Molecular Capabilities in a Combat Support Hospital. Wade K. Aldous, Ph.D. LTC, USA Edgie-Mark Co, Ph.D., M(ASCP), CPT, USA Edward Keen, Ph.D., M(ASCP), CPT USA. Background and Significance.

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Molecular Capabilities in a Combat Support Hospital

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  1. Molecular Capabilities in a Combat Support Hospital 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. Background and Significance • 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).

  3. 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

  4. JBAIDS • 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 and H1N1 • 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 • 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

  6. Q Fever • 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 ml of sample

  7. Data and results • Sample Size = 17 • JBAIDS compared to serology • Sensitivity = 67% • Specificity = 100% • Convalescent serology used as the gold standard

  8. Challenges for Q Fever Assay • Reagent availability in theater • Contamination issues • Dust? • Positive control? • Training/trouble-shooting

  9. H1N1 • 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 ml of transport media

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

  11. Challenges for H1N1 Assay • 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. Summary and Recommendations • 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

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