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COL JAMES SWABY Chief Clinical Research Division Wilford Hall Medical Center Comm: (210) 292-7068) DSN: 554-7068 Support.

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Presentation on theme: "COL JAMES SWABY Chief Clinical Research Division Wilford Hall Medical Center Comm: (210) 292-7068) DSN: 554-7068 Support."— Presentation transcript:

1 COL JAMES SWABY Chief Clinical Research Division Wilford Hall Medical Center Comm: (210) ) DSN: Support of Far-Forward Disease Surveillance Operations with Deployable, Real-Time Vector-Borne Disease Agent Analytic Capability February, 2010

2 Vector Surveillance Analytic System (VSAS) Disease agent detection platform: - Portable (one person) - Field-durable - Field-sustainable - Real-time PCR - RAPID JBAIDS Far forward disease surveillance Leish, Kenya 2008 Dengue,Thailand 2007 Operating off Car Battery RAPID

3 Rugadized Advanced Pathogen Identification Devise RAPID

4 Origins RAPID Used in CBAWS - Chemical & Biological Detection System - Detector Alarmed - Detector Collected Sample Sample - Individual Collected Filter Filter - Sample Taken to Lab - Real-time PCR - RAPID

5 Origins Redirected to LeishmaniasisControlProgram First target: Dengue Dengue, Honduras 2002 Cutaneous Leishmaniasis Tallil AB, Iraq 2003 Photos – LTC Weina

6 Operational Application Leish. surveillance support: - USA Prev. Medicine & - USAF Pub Health Force protection support: Iraq: Afghanistan : Iraq: Afghanistan : - Tallil AB - Kabul - Tallil AB - Kabul - Camp Victory - Camp Victory - Balad AB - Balad AB - Kirkuk AB - Kirkuk AB Control Surveillance Leish,Tallil AB, Iraq 2003

7 Operations. Operates as: - Stand alone field surveillance activity - Extension of deployable assets: -- USA TAML -- USA TAML -- AF BAT -- AF BAT AF BAT USA TAML Tallil AB, Iraq 2003 Hanta Virus 2003

8 Proven in diverse operations & environmental conditions: - Leishmania Southwest Asia, 2003, Leishmania Kenya, 2009, Dengue, JTF Bravo, Honduras Dengue, AFRIMS, Thailand 2003, 2007, Malaria, AFRIMS, Thailand Genomics-based id. Haughton-Mars Project, NASA, Devon Island, Arctic Devon Island, Arctic Field Testing NASA Haughton-Mars Project Devon Island, Arctic

9 JPEO-CBD requirement = ID. Tech for ops. diseases. - JPEO threat agent list - Includes Dengue (block 1, tier 2) & Leish. - Adopted JBAID analytic system - Incrementally establishing VSAS as component of JBAID JBAID Lineage RAPID Light Cycler JBAIDS

10 Components - Assays (freeze dried): field-durable, real-time - Positive controls - Negative controls - Preformatted reagents - PCR water - RAPID or JBAIDS ITI reagent kit color coded simplifies preparation simplifies preparation

11 Extract Purification Kit - Commercial off the shelf -- Thermally stable -- Thermally stable -- Preformatted -- Preformatted -- No 4 o C cold chain -- No 4 o C cold chain -- RAPID mini centrifuge -- RAPID mini centrifuge -- Adopted for: -- Adopted for: --- Field-worthiness --- Field-worthiness --- Applicable to RNA & DNA --- Applicable to RNA & DNA -- AVL lysis buffer -- AVL lysis buffer --- Inactivates agents --- Inactivates agents --- RNA remains stable days to weeks --- RNA remains stable days to weeks -- Kit purifies nucleic acid from diverse matrices -- Kit purifies nucleic acid from diverse matrices --- Mammalian fluids/tissues --- Mammalian fluids/tissues --- Arthropods homogenate --- Arthropods homogenate

12 Assays - Assay primers & probes designed de novo - Freeze-dried reagents made by ITI® - Standardized for PCR and RT-PCR - Assays only require hydration & sample for analysis - Thermal stability: -- Eliminates: -- Eliminates: o cold chain, o cold chain, --- Cold storage --- Cold storage --- Resupply issues --- Resupply issues -- Enhances mobility -- Enhances mobility

13 RAPID - Commercialized version of JBAIDS -- Assays easily transitioned -- Assays easily transitioned -- Real-time fluorimeter -- Real-time fluorimeter -- Closed capillary design -- Closed capillary design sample capacity sample capacity -- Laptop runs PCR cycling -- Laptop runs PCR cycling -- Automated data -- Automated data management management -- Mini Centrifuge for: -- Mini Centrifuge for: --- Sample prep --- Sample prep --- Capillary loading --- Capillary loading Laptop RAPID Centrifuge

14 Field Durable - Fits in 2 hardened & waterproofed cases -- RAPID -- RAPID -- Several hundred assays -- Several hundred assays -- Processing supplies -- Processing supplies -- Power converter -- Power converter -- Power cables -- Power cables - Transportation -- Personal equipment -- Personal equipment -- Vehicle -- Vehicle -- Helicopter -- Helicopter -- Fixed Wing (baggage) -- Fixed Wing (baggage) One man transportable

15 - Small footprint -- Hand-carried -- Hand-carried -- Vehicle tailgate -- Vehicle tailgate - Power sources & 220V AC & 220V AC --- Fixed structure --- Fixed structure --- Generator --- Generator 110 – 220 V AC Generator Field Durable Dengue, Thailand 2007 RAPID Malaria, Thailand 2008

16 Converter Running vehicle - Power sources -- 12V DC -- 12V DC VSAS Field Durable Battery Dengue, Thailand 2007 Dengue, Thailand 2008

17 - Easy set up & operation -- Configured in 10 min. -- Configured in 10 min. -- Processing & analysis 2 hrs. -- Processing & analysis 2 hrs. -- Sample processing & -- Sample processing & master mix prep. master mix prep. --- Preformatted reagents --- Preformatted reagents --- Sample prep. Kits --- Sample prep. Kits --- Closed capillary design --- Closed capillary design -- No hood -- No hood -- No spatial separation -- No spatial separation Easy set up Field Durable Malaria, Thailand 2008

18 - Safety -- Knowledge of vectors -- Knowledge of vectors -- Skill -- Skill -- Personal protective equip. -- Personal protective equip. Safety gear Knowledge Field Durable Dengue, Honduras 2002 Skill Malaria, Thailand 2008

19 VSAS Provides “Real-time” Risk Assessment - Affects time-critical & focused measures: -- Prevention -- Prevention -- Control -- Control -- Most effective approach -- Most effective approach - Reduce risk -- Focus on high risk areas -- Focus on high risk areas --- Infected vectors --- Infected vectors --- Breeding Populations --- Breeding Populations Breeding site Aedes aegypti Yellow Fever Dengue Dengue, Honduras 2002

20 - To effect disease: -- Risk assessment -- Risk assessment -- Prevention -- Prevention -- Control -- Control VSAS Provides Deployable Real-time Diagnostics Prevention Control Assessment Leish,Tallil AB, Iraq 2003

21 Products To Date - Concurrently submitting to JPEO - JBAIDS for FDA approval for FDA approval -- Dengue Universal already in testing -- Dengue Universal already in testing - AFPMB Approved Surveillance Assays -- Leish.: -- Leish.: --- LEIS --- LEIS --- LVL --- LVL -- Dengue -- Dengue --- DU-JCM --- DU-JCM - DOD ID Protection -- LEIS (D&RI) -- LEIS (D&RI) -- LVL (D&RI) -- LVL (D&RI) -- Dengue (pending) -- Dengue (pending) - 6 Publications Leish, Kenya 2008

22 Currently Status Diarrheal Diseases AssayRank*Activities UnderwayComments E. coli enterotoxigenic (ETEC) Heat Labile Toxin (LT)2JPO/JBAIDS Sub PrepDried Assay Validated Heat Stable Toxin (ST1a)2JPO/JBAIDS Sub PrepDried Assay Validated Heat Stable Toxin (ST1b)2JPO/JBAIDS Sub PrepDried Assay Validated Shigella spp2Dried Assay ValidationWet Assay Optimized Cryptosporidium spp12Dried Assay ProductionWet Assay Optimized NorovirusN/AWet Assay OptimizationFunded FY10 *Global Risk Index

23 Currently Status Vectorborne Diseases AssayRank*Activities UnderwayComments Dengue virus3Deployed SurveillanceAFPMB Approved Chikungunya virus6Wet Assay OptimizationFunded FY10 Aedes aegypti mosquitoeN/ADeployed SurveillanceAFPMB Sub Planned Leishmania spp30Deployed SurveillanceAFPMB Approved Leishmania visceral genotype20Deployed SurveillanceAFPMB Approved Leishmania human pathogenicvariousWet Assay OptimizationFunded FY10 Leptospira human pathogenic7Dried Assay ValidationField Val Planned Leptospira spp7Dried Assay ProductionWet Assay Optimized Plasmodium spp, P. f and P. v1Wet Assay OptimizationFunded FY10 Flavivirus sppvariousWet Assay OptimizationFunded FY10 Japanese enchephalitis virus24Wet Assay OptimizationFunded FY10 *Global Risk Index (Burnette et al., 2008)

24 Grants, >$700K, for: -- Enhanced Plasmodium genus assay -- Leishmaniasis panel -- Japanese Encephalitis -- Sticky Ovitrap: --- Chikungunya --- Chikungunya --- Dengue --- Dengue -- Norovirus Future Malaria, Thailand 2008

25 Joint Effort - Air Force: -- SGR -- SGR CRD CRD - Army: -- WRAIR -- AFRIMS -- WRAIR -- AFRIMS -- USAMRU-K -- USAMRU-K - Navy: NMRC - ITI via CRADA


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