DSN: 554-7068 email: james.swaby@Lackland.af.mil Support of Far-Forward Disease Surveillance Operations with Deployable, Real-Time Vector-Borne Disease Agent Analytic Capability February, 2010 COL JAMES SWABY Chief Clinical Research Division Wilford Hall Medical Center Comm: (210) 292-7068) DSN: 554-7068 email: james.swaby@Lackland.af.mil

Vector Surveillance Analytic System (VSAS) Disease agent detection platform: Portable (one person) Field-durable Field-sustainable Real-time PCR - RAPID JBAIDS Dengue,Thailand 2007 Leish, Kenya 2008 RAPID Abstract: The Vector Surveillance Analytic System (VSAS) is a portable, field-durable, field-sustainable, real-time, arthropod-borne disease agent detection platform used to support disease surveillance operations at far forward locations. The VSAS operates as a stand-alone field surveillance activity or as an extension of other deployable assets. The field utility of the VSAS is clearly proven in diverse operational applications and environmental conditions. The VSAS provides deployable analytic capability for real-time vector-borne disease risk assessment which is paramount in affecting time-critical and focused disease preventative and control measures. From AMED VSAS article: The Vector Surveillance Analytic System (VSAS) is a portable, field-durable, field-sustainable, real-time, disease agent detection platform used to support disease surveillance operations at far forward locations. The VSAS was originally developed to establish a DoD deployable methodology for dengue virus detection, but focus on system capability was redirected to Leishmania detection and deployed in August 2003 to support the Leishmaniasis Control Program (LCP) of the 520th Theater Army Medical Laboratory, Tallil Air Base (AB), Iraq.1 The mobility of the VSAS allowed direct support to US Army Preventive Medicine and US Air Force Public Health Leishmania surveillance operations throughout the LCP area of responsibility. Force health protection support was provided at Camp Victory, Baghdad International Airport AB, Balad AB, and Kirkuk AB, Iraq, and Kabul, Afghanistan, from February to October of 2004. Operating off Car Battery Far forward disease surveillance

Rugadized Advanced Pathogen Identification Devise RAPID 3

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

Cutaneous Leishmaniasis Tallil AB, Iraq 2003 Origins Dengue, Honduras 2002 Cutaneous Leishmaniasis Tallil AB, Iraq 2003 First target: Dengue From AMED VSAS article: The Vector Surveillance Analytic System (VSAS) is a portable, field-durable, field-sustainable, real-time, disease agent detection platform used to support disease surveillance operations at far forward locations. The VSAS was originally developed to establish a DoD deployable methodology for dengue virus detection, but focus on system capability was redirected to Leishmania detection and deployed in August 2003 to support the Leishmaniasis Control Program (LCP) of the 520th Theater Army Medical Laboratory, Tallil Air Base (AB), Iraq. The mobility of the VSAS allowed direct support to US Army Preventive Medicine and US Air Force Public Health Leishmania surveillance operations throughout the LCP area of responsibility. Force health protection support was provided at Camp Victory, Baghdad International Airport AB, Balad AB, and Kirkuk AB, Iraq, and Kabul, Afghanistan, from February to October of 2004. Redirected to Leishmaniasis Control Program Photos – LTC Weina

Operational Application Leish. surveillance support: - USA Prev. Medicine & - USAF Pub Health Leish,Tallil AB, Iraq 2003 Leish,Tallil AB, Iraq 2003 Surveillance Force protection support: Iraq: Afghanistan: - Tallil AB - Kabul - Camp Victory - Balad AB - Kirkuk AB From AMED VSAS article: The Vector Surveillance Analytic System (VSAS) is a portable, field-durable, field-sustainable, real-time, disease agent detection platform used to support disease surveillance operations at far forward locations. The VSAS was originally developed to establish a DoD deployable methodology for dengue virus detection, but focus on system capability was redirected to Leishmania detection and deployed in August 2003 to support the Leishmaniasis Control Program (LCP) of the 520th Theater Army Medical Laboratory, Tallil Air Base (AB), Iraq. The mobility of the VSAS allowed direct support to US Army Preventive Medicine and US Air Force Public Health Leishmania surveillance operations throughout the LCP area of responsibility. Force health protection support was provided at Camp Victory, Baghdad International Airport AB, Balad AB, and Kirkuk AB, Iraq, and Kabul, Afghanistan, from February to October of 2004. Control

Operations Operates as: . Stand alone field surveillance activity Extension of deployable assets: -- USA TAML -- AF BAT . Hanta Virus 2003 Tallil AB, Iraq 2003 Abstract: The Vector Surveillance Analytic System (VSAS) is a portable, field-durable, field-sustainable, real-time, arthropod-borne disease agent detection platform used to support disease surveillance operations at far forward locations. The VSAS operates as a stand-alone field surveillance activity or as an extension of other deployable assets. The field utility of the VSAS is clearly proven in diverse operational applications and environmental conditions. The VSAS provides deployable analytic capability for real-time vector-borne disease risk assessment which is paramount in affecting time-critical and focused disease preventative and control measures. From AMED VSAS article: The VSAS operates as a standalone field surveillance activity or as an extension of other deployable assets, such as the US Theatre Army Area Medical Laboratory or the Air Force Biological Augmentation Team. The field utility of the VSAS is clearly proven in diverse operational applications and environmental conditions; Leishmania surveillance Southwest Asia,2 dengue surveillance at Joint Task Force Bravo, Honduras,3,4 and with the Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.5 It has also been adapted for use in the Arctic by NASA* in the development of genomics-based identification methodologies for the Haughton-Mars Project† on Devon Island in the Territory of Nunavut, Canada. USA TAML AF BAT

Field Testing Proven in diverse operations & environmental conditions: Leishmania Southwest Asia, 2003, 2004 Leishmania Kenya, 2009, 2010 Dengue, JTF Bravo, Honduras 2002 Dengue, AFRIMS, Thailand 2003, 2007, 2008 Malaria, AFRIMS, Thailand 2008 Genomics-based id. Haughton-Mars Project, NASA, Devon Island, Arctic Abstract: The Vector Surveillance Analytic System (VSAS) is a portable, field-durable, field-sustainable, real-time, arthropod-borne disease agent detection platform used to support disease surveillance operations at far forward locations. The VSAS operates as a stand-alone field surveillance activity or as an extension of other deployable assets. The field utility of the VSAS is clearly proven in diverse operational applications and environmental conditions. The VSAS provides deployable analytic capability for real-time vector-borne disease risk assessment which is paramount in affecting time-critical and focused disease preventative and control measures. From AMED VSAS article: The VSAS operates as a standalone field surveillance activity or as an extension of other deployable assets, such as the US Army Area Medical Laboratory or the Air Force Biological Augmentation Team. The field utility of the VSAS is clearly proven in diverse operational applications and environmental conditions; Leishmania surveillance Southwest Asia, dengue surveillance at Joint Task Force Bravo, Honduras,3,4 and with the Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand. It has also been adapted for use in the Arctic by NASA* in the development of genomics-based identification methodologies for the Haughton-Mars Project† on Devon Island in the Territory of Nunavut, Canada. NASA Haughton-Mars Project Devon Island, Arctic

Lineage 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 RAPID From AMED VSAS article: The VSAS addresses a requirement established by the Joint Program Executive Office (JPEO) for Chemical and Biological Defense for the development of deployable identification technologies for disease agents of operational significance. The JPEO has designated Leishmania and dengue virus as threat agents (Block 1, Tier 2). To address that threat, testing is underway to incrementally establish VSAS technologies as subcomponents of the Joint Biological Agent Identification and Diagnostic System (JBAIDS), a JPEO/DoD accepted analytic system. JBAIDS Light Cycler

ITI reagent kit color coded simplifies preparation Components - Assays (freeze dried): field-durable, real-time Positive controls - Negative controls Preformatted reagents PCR water RAPID or JBAIDS From AMED VSAS article: The VSAS is composed of: Thermally-stable, hydrolytic enzyme resistant, freeze-dried, dual-fluorogenic, polymerase chain reaction (PCR) and reverse transcription-PCR (RT-PCR) assays and positive control template, genomic DNA and Armored-RNA® (Asuragen, Incorporated, Austin, Texas)., Preformatted sample stabilization and processing materials. The ITI vector surveillance reagent kit is preformatted with color coding to simplify preparation.). ITI reagent kit color coded simplifies preparation

Extract Purification Kit Commercial off the shelf -- Thermally stable -- Preformatted -- No 4o C cold chain -- RAPID mini centrifuge -- Adopted for: --- Field-worthiness --- Applicable to RNA & DNA -- AVL lysis buffer --- Inactivates agents --- RNA remains stable days to weeks -- Kit purifies nucleic acid from diverse matrices --- Mammalian fluids/tissues --- Arthropods homogenate From AMED VSAS article: Arthropod nucleic acid extracts are prepared with a commercially available, off-the-shelf, thermally stable, preformatted, guanidinium thiocyanate based total nucleic acid (DNA and RNA) purification kit, QIAamp Viral RNA Mini Kit (QIAGEN, 27220 Turnberry Lane, Valencia, California 91355). Extract is prepared following the manufacture’s spin protocol with the exception that the carrier RNA step is not implemented, thus eliminating the need for a 4°C cold chain. Also, centrifugation steps are adapted to the RAPID mini centrifuge, eliminating the need for a tabletop centrifuge. This kit has been adopted because of its field-worthiness and its capability to extract total nucleic acid in a standardized, single protocol which is applicable to organisms harboring either RNA or DNA genomes. Two other advantages of the kit are the lysis buffer, "Anschlagpuffer Virus Lysis" (AVL), which has been shown to inactivate infectious agents, thus providing an additional level of safety when processing samples, and the genomic RNA template, which has been shown to remain stable in AVL at ambient temperatures (25ºC to 37ºC) for days to weeks. The kit efficiently purifies nucleic acid from diverse matrices, to include mammalian body fluids and tissues and arthropod homogenate. 11

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: --- -20o cold chain, --- Cold storage --- Resupply issues -- Enhances mobility From AMED VSAS article: Assay primer and probe oligonucleotides are designed de novo, and freeze-dried PCR reagents are manufactured by ITI. Assays are prepared using an ITI proprietary formulation that is formatted to standardized PCR and RT-PCR thermal cycling protocols. Freeze-dried assays only require hydration and addition of sample template prior to analysis. The thermal-stable property of the assays eliminate the need for a -20°C cold chain that is typically required for PCR reagents, thus vastly enhancing the mobility of the system. It also eliminates cold storage and resupply requirements that are unacceptable under far forward deployed conditions

RAPID RAPID Laptop Centrifuge Commercialized version of JBAIDS -- Assays easily transitioned -- Real-time fluorimeter -- Closed capillary design -- 32 sample capacity -- Laptop runs PCR cycling -- Automated data management -- Mini Centrifuge for: --- Sample prep --- Capillary loading Laptop RAPID Centrifuge From AMED VSAS article: RAPID PCR thermocycler, is a real-time fluorimeter with a closed capillary design and 32-sample capacity. The thermocycler is operated by a laptop computer with programmable PCR cycling conditions. Data management is automated. The RAPID mini centrifuge is used for sample preparation and capillary loading. The RAPID thermocycler is the commercialized version of the JBAIDS thermocycler. Since the technologies of these thermocyclers are essentially identical, assays can be readily transitioned from one instrument to the other

Field Durable Fits in 2 hardened & waterproofed cases -- RAPID -- Several hundred assays -- Processing supplies -- Power converter -- Power cables One man transportable From AMED VSAS article: The VSAS, including several hundred assays and sample processing materials, are transported in 2 hardened, waterproof cases (63 X 49.2 X35.2 cm). Two-man transportable, field-durable, real-time PCR instrumentation: the Ruggedized Advanced Pathogen Identification Device (RAPID®) (Idaho Technology Incorporated [ITI], Salt Lake City, UtahThe VSAS is routinely transported as personal equipment on military helicopters or fixed-wing aircraft, or transported on commercial airlines as baggage. Ground transportation is by light vehicle or carried manually. The small footprint of the VSAS allows configuration on a truck tailgate with the system powered by a 110V or 220V source, usually an electric generator, or, if necessary, the 12V battery of a vehicle with the engine running. The efficiency of preformatted reagent and sample preparation kits, along with the closed capillary design of the RAPID, permit sample processing and master mix preparation to be conducted without a biological containment hood or spatial separation. However, in order to tailor protective measures to the surveillance requirements, appropriate operator personnel protective equipment must be provided and personnel made aware of which vector(s) will be recovered. System configuration requires about 10 minutes, and sample processing and analysis less than 2 hours. Transportation -- Personal equipment -- Vehicle -- Helicopter -- Fixed Wing (baggage)

Field Durable 110 – 220 V AC - Small footprint -- Hand-carried -- Vehicle tailgate - Power sources -- 110 & 220V AC --- Fixed structure --- Generator Malaria, Thailand 2008 Dengue, Thailand 2007 110 – 220 V AC The VSAS, including several hundred assays and sample processing materials, are transported in 2 hardened, waterproof cases (63 X 49.2 X35.2 cm). The VSAS is routinely transported as personal equipment on military helicopters or fixed-wing aircraft, or transported on commercial airlines as baggage. Ground transportation is by light vehicle or carried manually. The small footprint of the VSAS allows configuration on a truck tailgate with the system powered by a 110V or 220V source, usually an electric generator, or, if necessary, the 12V battery of a vehicle with the engine running. The efficiency of preformatted reagent and sample preparation kits, along with the closed capillary design of the RAPID, permit sample processing and master mix preparation to be conducted without a biological containment hood or spatial separation. However, in order to tailor protective measures to the surveillance requirements, appropriate operator personnel protective equipment must be provided and personnel made aware of which vector(s) will be recovered. System configuration requires about 10 minutes, and sample processing and analysis less than 2 hours. Generator RAPID

VSAS Field Durable Running vehicle Battery - Power sources -- 12V DC Dengue, Thailand 2007 - Power sources -- 12V DC Converter Dengue, Thailand 2008 Running vehicle From AMED VSAS article: The VSAS, including several hundred assays and sample processing materials, are transported in 2 hardened, waterproof cases (63 X 49.2 X35.2 cm). The VSAS is routinely transported as personal equipment on military helicopters or fixed-wing aircraft, or transported on commercial airlines as baggage. Ground transportation is by light vehicle or carried manually. The small footprint of the VSAS allows configuration on a truck tailgate with the system powered by a 110V or 220V source, usually an electric generator, or, if necessary, the 12V battery of a vehicle with the engine running. The efficiency of preformatted reagent and sample preparation kits, along with the closed capillary design of the RAPID, permit sample processing and master mix preparation to be conducted without a biological containment hood or spatial separation. However, in order to tailor protective measures to the surveillance requirements, appropriate operator personnel protective equipment must be provided and personnel made aware of which vector(s) will be recovered. System configuration requires about 10 minutes, and sample processing and analysis less than 2 hours. Battery

Field Durable Easy set up Easy set up & operation -- Configured in 10 min. -- Processing & analysis 2 hrs. -- Sample processing & master mix prep. --- Preformatted reagents --- Sample prep. Kits --- Closed capillary design -- No hood -- No spatial separation Malaria, Thailand 2008 Easy set up From AMED VSAS article: System configuration requires about 10 minutes, and sample processing and analysis less than 2 hours.

Field Durable Skill Safety gear Knowledge Malaria, Thailand 2008 -- Knowledge of vectors -- Skill -- Personal protective equip. Skill From AMED VSAS article: The VSAS, including several hundred assays and sample processing materials, are transported in 2 hardened, waterproof cases (63 X 49.2 X35.2 cm). The VSAS is routinely transported as personal equipment on military helicopters or fixed-wing aircraft, or transported on commercial airlines as baggage. Ground transportation is by light vehicle or carried manually. The small footprint of the VSAS allows configuration on a truck tailgate with the system powered by a 110V or 220V source, usually an electric generator, or, if necessary, the 12V battery of a vehicle with the engine running. The efficiency of preformatted reagent and sample preparation kits, along with the closed capillary design of the RAPID, permit sample processing and master mix preparation to be conducted without a biological containment hood or spatial separation. However, in order to tailor protective measures to the surveillance requirements, appropriate operator personnel protective equipment must be provided and personnel made aware of which vector(s) will be recovered. System configuration requires about 10 minutes, and sample processing and analysis less than 2 hours. Safety gear Knowledge Dengue, Honduras 2002

“Real-time” Risk Assessment VSAS Provides “Real-time” Risk Assessment Affects time-critical & focused measures: -- Prevention -- Control -- Most effective approach Dengue Yellow Fever From AMED VSAS article: The VSAS provides deployable analytic capability for real-time vector-borne disease risk assessment. This is paramount in affecting time-critical and focused disease prevention and control measures. This is especially relevant to leishmaniasis and dengue fever because, in the absence of a vaccine or prophylactic drug, the only means of protecting deployed military personnel is the prevention of bites by infected arthropods. Prevention and control of transmission is most effectively achieved through heightened awareness of the need for personal protective measures, and by reduction in vector populations. Focused application of insecticides and elimination of breeding habitat in areas where the risk is greatest— where infected vectors and breeding populations are found—are the most effective uses of vector control resources to reduce transmission. Aedes aegypti - Reduce risk -- Focus on high risk areas --- Infected vectors --- Breeding Populations Breeding site Dengue, Honduras 2002

Deployable Real-time Diagnostics VSAS Provides Deployable Real-time Diagnostics Assessment Leish,Tallil AB, Iraq 2003 To effect disease: -- Risk assessment -- Prevention -- Control Prevention Control Leish,Tallil AB, Iraq 2003 Abstract: The Vector Surveillance Analytic System (VSAS) is a portable, field-durable, field-sustainable, real-time, arthropod-borne disease agent detection platform used to support disease surveillance operations at far forward locations. The VSAS operates as a stand-alone field surveillance activity or as an extension of other deployable assets. The field utility of the VSAS is clearly proven in diverse operational applications and environmental conditions. The VSAS provides deployable analytic capability for real-time vector-borne disease risk assessment which is paramount in affecting time-critical and focused disease preventative and control measures. From AMED VSAS article: The VSAS provides deployable analytic capability for real-time vector-borne disease risk assessment. This is paramount in affecting time-critical and focused disease prevention and control measures. This is especially relevant to leishmaniasis and dengue fever because, in the absence of a vaccine or prophylactic drug, the only means of protecting deployed military personnel is the prevention of bites by infected arthropods. Prevention and control of transmission is most effectively achieved through heightened awareness of the need for personal protective measures, and by reduction in vector populations. Focused application of insecticides and elimination of breeding habitat in areas where the risk is greatest — where infected vectors and breeding populations are found—are the most effective uses of vector control resources to reduce transmission.

Products To Date Concurrently submitting to JPEO - JBAIDS for FDA approval -- Dengue Universal already in testing AFPMB Approved Surveillance Assays -- Leish.: --- LEIS --- LVL -- Dengue --- DU-JCM DOD ID Protection -- LEIS (D&RI) -- LVL (D&RI) -- Dengue (pending) 6 Publications Leish, Kenya 2008 The Armed Forces Pest Management Board (AFPMB) has approved Leishmania genus (LEIS), visceral genotype (LVL) PCR assays Dengue universal assays as DoD accepted methodologies for Leishmania and Dengue vector surveillance.

Currently Status Diarrheal Diseases Assay Rank* Activities Underway   Assay Rank* Activities Underway Comments E. coli enterotoxigenic (ETEC) Heat Labile Toxin (LT) 2 JPO/JBAIDS Sub Prep Dried Assay Validated Heat Stable Toxin (ST1a) Heat Stable Toxin (ST1b) Shigella spp Dried Assay Validation Wet Assay Optimized Cryptosporidium spp 12 Dried Assay Production Norovirus N/A Wet Assay Optimization Funded FY10 *Global Risk Index Joint Biological Agent Identification and Diagnostic System (JBAIDS)

Currently Status Vectorborne Diseases Assay Rank* Activities Underway   Assay Rank* Activities Underway Comments Dengue virus 3 Deployed Surveillance AFPMB Approved Chikungunya virus 6 Wet Assay Optimization Funded FY10 Aedes aegypti mosquitoe N/A AFPMB Sub Planned Leishmania spp 30 Leishmania visceral genotype 20 Leishmania human pathogenic various Leptospira human pathogenic 7 Dried Assay Validation Field Val Planned Leptospira spp Dried Assay Production Wet Assay Optimized Plasmodium spp, P. f and P. v 1 Flavivirus spp Japanese enchephalitis virus 24 *Global Risk Index (Burnette et al., 2008) Joint Biological Agent Identification and Diagnostic System (JBAIDS)

Future 2010 Grants, >$700K, for: -- Enhanced Plasmodium genus assay -- Leishmaniasis panel -- Japanese Encephalitis -- Sticky Ovitrap: --- Chikungunya --- Dengue -- Norovirus Malaria, Thailand 2008 Leishmaniasis hypothesis: Leishmaniasis force health protection can be enhanced by complete Leishmania epidemiology vector surveillance field deployable RAPID and JBAIDS assays. Leishmaniasis Technical Objectives: The following objectives will be accomplished in this study: 1. Establish an optimal research-grade (wet) assay panel on the RAPID and JBAIDS. 2. Establish an optimal freeze-dried assay panel on the RAPID and JBAIDS. 3. Validate performance of the assay panel and seek approval from the AFPMB and JBAIDS program manager for use in environmental surveillance. 4. Assess and evaluate assay performance on the RAPID and JBAIDS using clinical specimens and seek approval from the JPO/JBAIDS program manager as a qualified candidate assay for future FDA-clearance on the JBAIDS under a separate research proposal in the future. Cryptosporidium Hypothesis: It is possible to do real-time identification and diagnosis of a significant etiologic agent of bacterial diarrhea in the field by transitioning a currently existing (developmental phase) Cryptosporidium spp. PCR (TaqMan) assay in a field expedient format to the JBAIDS platform. Transitioning the existing Cryptosporidium spp. PCR (TaqMan) assay to the JBAIDS platform will allow field deployable rapid diagnostic tools for screening of this debilitating disease in endemic areas. Cryptosporidium Technical Objectives: 1. Establish an optimal research-grade (wet) assay on the RAPID and JBAIDS. 2. Establish an optimal freeze-dried assay on the RAPID and JBAIDS. 3. Validate performance of the assay and seek approval from the JBAIDS program manager for use in environmental surveillance. Environmental surveillance validation will include relevant environmental matrices, including water samples. 4. Conduct side-by-side comparison testing of Stool Specimen Processing Protocols and seek approval from the JPO/JBAIDS program manager for use in environmental surveillance and as a candidate protocol for future FDA-clearance on the JBAIDS under a separate research proposal. 5. Assess and evaluate assay performance on the RAPID and JBAIDS using clinical specimens and seek approval from the JPO/JBAIDS program manager as a qualified candidate assay for future research targeted at getting FDA-clearance for human diagnostics on the JBAIDS under a separate research proposal.   Dengue hypothesis: Performance of the current DoD Dengue virus vector surveillance assay can be significantly increased by reformulation with an enhanced polymerase. Reformulation will allow the assay to be run using standard JBAIDS RT-PCR reaction conditions, giving the JBAIDS operator the ability to run this test with other JBAIDS tests simultaneously. Dengue technical objectives: 1. Establish an optimal freeze-dried assay on the RAPID and JBAIDS. 2. Validate performance of the reformulated assay on the RAPID and seek approval from the Armed Forces Pest Management Board (AFPMB) for use in vector/vector-borne disease surveillance. 3. Validate performance of the reformulated assay on the JBAIDS and seek approval by the JBAIDS program manager as a candidate assay for potential use in environmental (non-human) surveillance on the JBAIDS. 4. Assess and evaluate assay performance on the RAPID and JBAIDS using clinical specimens and seek approval by the JBAIDS program manager as a qualified candidate assay for potential FDA-clearance under a separate research proposal in the future.   Assess internal positive control performance. Plasmodium hypothesis: It is possible to develop and package a field-deployable, far forward sustainable, JBAIDS- based vector surveillance and diagnostic assay to detect etiologic agents causing malaria. Plasmodium technical Objectives: 2. Validate performance of the assay on the RAPID and seek approval from the Armed Forces Pest Management Board (AFPMB) for use in vector/vector-borne disease surveillance. 3. Validate performance of the assay on the JBAIDS and seek approval by the JBAIDS program manager as a candidate assay for potential use in environmental (non-human) surveillance on the JBAIDS. 4. Assess and evaluate assay performance on the RAPID and JBAIDS using clinical specimens and seek approval by the JBAIDS program manager as a qualified candidate assays for future research targeted at getting FDA-clearance for human diagnostics on the JBAIDS under a separate research proposal..

Joint Effort Air Force: -- SGR -- 59 CRD Army: -- WRAIR -- AFRIMS -- USAMRU-K - Navy: NMRC - ITI via CRADA From AMED VSAS article: The VSAS is a joint US Air Force, Army, and Navy product developed through a Cooperative Research and Development Agreement with ITI, the JPEO primary contractor.