Wade K. Aldous, Ph.D. LTC, USAEdgie-Mark Co, Ph.D., M(ASCP), CPT, USA

Edward Keen, Ph.D., M(ASCP), CPT USA

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).

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

Reagent availability in theater

Contamination issues◦ Dust?◦ Positive control?

Training/trouble-shooting

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