|Acquisition Program: ||MRMC Deputy for Acqusition|| Objective: ||To develop, evaluate and commercialize a multiplexed field deployable assay capable of identifying Leishmania and differentiating between human vs. non-human infecting species from sand flies collected from deployed military service areas. The assay should be able to further differentiate the human infecting Leishmania species.
|| Description: ||Effective surveillance relies on quick and accurate detection of a pathogen in its corresponding vector. Effective surveillance provides the ability to assess the true risk of infections as well as help to determine where to focus prevention and treatment programs. To accomplish this surveillance areas are monitored by catching large numbers of the vector from a variety of locations using a variety of traps. The insects then need to be tested for the disease of interest, in this case, Leishmania species. Complicating matters in the surveillance of Leishmania is the fact that human and non human infecting species exist. Not being able to differentiate human infecting species inflates the infection rate of the sand flies possibly causing the improper implementation of prevention and treatment programs. In addition, knowing which human infecting species is currently circulating in an area is extremely important since some species of Leishmania are more virulent and would require more aggressive surveillance and treatment programs. Because this work often takes place in a field setting, a test that is quick, field deployable and accurate for the species determination of Leishmania is needed.
Desired Capability: The goal of this SBIR is to successfully develop and commercialize a multiplexed, field deployable assay to detect and differentiate human vs. non-human infecting species in the sand fly vector. Additionally the assay should be able to determine the species of human infecting Leishmania. The assay should be rapid (less than 4 hours), heat stable (no cold chain required) and have a small logistical footprint. If nucleic acid aid amplification is used, sample preparation should be included in the assay. The assay should be at least as specific as the gold standard assays (culture and iso-enzyme analysis).
Access to govt. facilities and supplies: Reagents, controls, infected sand flies etc, to support this project may be available from the Walter Reed Army Institute of Research (WRAIR). The candidate contractor should coordinate with the Contracting Officer Representative (COR) for any support needed from WRAIR.
|| ||PHASE I: The selected contractor will determine the feasibility of the concept by a developing prototype assays (to include any nucleic acid purification and amplification equipment required) that will detect and differentiate human vs. non-human infecting species in the sand fly vector. Additionally the assay should be able to determine the species of human infecting Leishmania. This development will be accomplished using cultured material. Proof of concept will be shown by the contractor by conducting an initial laboratory evaluation of the prototype assay with cultured Leishmania parasites and providing a written report to the COR. By the conclusion of Phase I, the selected contractor must provide the Contracting Officer Representative (COR) with sufficient prototype assays to establish the assay in a government laboratory. This will include any associated instruments and enough assays to carry out 100 tests. The selected contractor must coordinate with the COR to access any required reagents from the WRAIR. The degree to which the prototype assay meets the desired capability outlined above will be evaluated at the government laboratory. Data from this independent evaluation will be used in the determination of the Phase II awardee.
|| ||PHASE II: The goal in Phase II is the development of a prototype assay that is a least as sensitive and specific as the current gold standard assays for Leishmania detection and species identification. (culture and iso-enzyme analysis). Once sensitivity and specificity requirements have been met, the selected contractor shall conduct comprehensive laboratory evaluations of the assay performance characteristics (Limit of detection (LOD) sensitivity, specificity, positive / negative predictive value, accuracy and reliability) and initial field testing.
The selected contractor will also conduct stability testing of the device in Phase II. Stability testing should be conducted under both real-time and accelerated conditions. This will be done to attempt to force the product to fail under a broad range of temperature and humidity conditions and extremes.
The Walter Reed Army Institute of Research (WRAIR) may provide additional support in testing and evaluation of the developed device to include field trials. The selected contractor will coordinate well in advance with the COR to any support required by the WRAIR.
|| ||PHASE III: During this phase the performance of the assay should be evaluated in a variety of field studies that will conclusively demonstrate that the assay meets the requirements of this topic. By the conclusion of this phase the selected contractor will have completed the development of the assay and successfully commercialized the product. The contractor shall provide a report that summarizes the performance of the assay to the Armed Forces Pest Management Board and will request that a national stock number (NSN) be assigned. Contractor shall coordinate in advance with the COR for any support required from the WRAIR.
Military Application: Once an NSN has been assigned to the assay, the Armed Forces Pest Management Board will work with appropriate organizations to have the assay incorporated into appropriated “sets, kits, and outfits” that are used by deployed Preventive Medicine Units.
Commercial Application: This assay will also be available for non-military purposes, such as use by commercial pest controllers or non-governmental organizations (NGOs) in areas of the world where Leishmania is endemic. We envision that the contractor that develops the Leishmania assay will be able to market this assay to a variety of commercial, governmental and non-governmental vector control organizations, and that this market will be adequate to sustain the continued production of this device. By the end of this phase, the selected contractor shall make this product available to potential users throughout the world.
|| References: ||
1. Claborn, D., P. Masuoka, et al. (2008). "Habitat analysis of North American sand flies near veterans returning from leishmania-endemic war zones." Int J Health Geogr 7: 65.
2. Coleman, R. E., D. A. Burkett, et al. (2006). "Impact of phlebotomine sand flies on U.S. Military operations at Tallil Air Base, Iraq: 1. background, military situation, and development of a "Leishmaniasis Control Program"." J Med Entomol 43(4): 647-662.
3. Dujardin, J. C., L. Campino, et al. (2008). "Spread of vector-borne diseases and neglect of Leishmaniasis, Europe." Emerg Infect Dis 14(7): 1013-1018.
4. Sharma, N. L., V. K. Mahajan, et al. (2009). "The sandflies of the Satluj river valley, Himachal Pradesh (India): some possible vectors of the parasite causing human cutaneous and visceral leishmaniases in this endemic focus." J Vector Borne Dis 46(2): 136-140.
5. Shehata, M. G., A. M. Samy, et al. (2009). "First report of Leishmania tropica from a classical focus of L. major in North-Sinai, Egypt." Am J Trop Med Hyg 81(2): 213-218.
6. Silveira, F. T., E. A. Ishikawa, et al. (2002). "An outbreak of cutaneous leishmaniasis among soldiers in Belem, Para State, Brazil, caused by Leishmania (Viannia) lindenbergi n. sp. A new leishmanial parasite of man in the Amazon region." Parasite 9(1): 43-50.
7. Simon, S., V. Veron, et al. (2009). "Leishmania spp. identification by polymerase chain reaction-restriction fragment length polymorphism analysis and its applications in French Guiana." Diagn Microbiol Infect Dis.
8. Wasserberg, G., Z. Abramsky, et al. (2002). "The ecology of cutaneous leishmaniasis in Nizzana, Israel: infection patterns in the reservoir host, and epidemiological implications." Int J Parasitol 32(2): 133-143.|
|Keywords: ||leishmania, species, differentiation, field-deployable|