Chemical and Biological, Army STTR, Phase I
Food and Water Sensor for Sustainment of the Joint Expeditionary Force
Objective
Develop a multiplex detection system that can be used by an expeditionary force for the detection of pathogens in food and water using shelf-stable nanotechnology enabled assay.
Description
U.S. troops are deployed worldwide to places where commercial food sanitation standards may be inferior with poor enforcement. Survey data of military personnel deployed in Iraq or Afghanistan reported high rates of diarrhea, 70 and 54% respectively, for respondents. Higher rates in deployed personnel in Iraq was attributed to more access to local foods (26.6% in Iraq reported eating local food weekly compared to only 5.3% in Afghanistan).
There is significant risk to Warfighters consuming local food or water that contains pathogens. Pathogens can be naturally occurring or intentionally introduced. Current methods to detect pathogenic contamination in food/water such as culture counting, molecular diagnostics, and ELISA like assays require reagents with limited shelf-life, cold storage requirement, trained users, multiple manual steps, and long wait times. This topic seeks to utilize detection technologies to protect Warfighters from incidental or intentional contamination by verifying the safety of food/water.
Reducing the logistical burden associated with acquiring safe food and water will maintain expeditionary posture on extended missions up to 7 days without resupply as part of multi-domain operations.
Current detection systems for food/water pathogens require multiple pieces of equipment for a pre-enrichment/concentration of target in the food sample followed by multiple steps to isolate the pathogen from the sample matrix. These procedures increase the testing time and ultimately extends the overall time to response.
In addition, cold chain logistics is a key resource limiting factor that directly affects reagent stability and is not feasible for the expeditionary force. Recent advances in biotechnology, synthetic biology, nanotechnology, and artificial intelligence/machine learning provide opportunity to overcome many of these limitations and hurdles. The proposed concept would utilize a single hand-held test device that can provide a yes/no determination of food and water safety without the use of other supporting equipment elements in a resource limited environment.
This system would be capable of targeting enteric viruses, parasites, and bacteria. Viral targets would include Hepatitis A, Norovirus, Poliovirus, Rotavirus and Coxsackievirus. Parasite targets would include Giardia, Cryptosporidium, Schistosoma, Entamoeba histolytica and Cyclospora. Bacterial targets would include Shiga Toxigenic Escherichia coli (STEC), Listeria monocytogenes, Salmonella, coliforms and Campylobacter.
The overall size and weight of the system should be man portable with the objective of each individual component to be hand-held (threshold total system weight of less than 5lbs with the objective weight of less than 3lbs).
Stability of the system and reagents will need to be compatible with non-controlled environmental conditions to include extremes in temperature (low -40°F, high 160° F), freeze-thaw cycles, wide range of moisture condensing and non-condensing (RH% 10 to 90%). Shelf stability of reagents in the test kit is necessary and must not expire for at least one calendar year.
System will provide a rapid (threshold time to response < 8 hrs, objective time to response < 2 hrs) yes/no determination of safety without the need for user interpretations. An internal positive control and negative control for system readiness and test reagent verification will also be key requirements of the final system.
Phase I
Design and develop a proof-of-concept unit capable of demonstrating the performance requirements and metrics outlined above. Establish the feasibility, usability and practicality of the proposed design and materially demonstrate and validate the concept through preliminary testing. For Phase I the detection system would have to show the ability to detect one target from each group (virus, bacteria, and parasite) in water on a single test kit without using supporting laboratory equipment.
Detection of the targets would occur at levels that are high enough that enrichment would not be needed for bacterial targets. Detection system in this phase will be a breadboard unit. A preliminary cost analysis must be completed based on projected scale-up and manufacturability considerations. A final report shall be delivered that specifies how requirements will be met (including mitigation of risks associated with factors limiting system performance).
The report will detail the conceptual design, performance modeling and associated drawings (CAD or Solidworks® format), scalability of the proposed technology with predicted performance, safety and human interface (MANPRINT) factors, and estimated production costs. The projected technical readiness level (TRL) shall achieve a TRL of 3 and provide a clear path to Phase II/III and follow-on commercialization.
Phase II
Refine the technology developed during Phase I in accordance with the goals of the project. Fabricate and demonstrate a high fidelity, full scale, advanced prototype for the target warfighter application, verifying that the desired performance is met. Expand detection to the other four organisms in each group that were not addressed during Phase I. Phase II will also include sampling of food matrices for all of the pathogens in each group. Food samples will include spinach, strawberries, and ground beef. Phase II will also maximize sensitivity improving on the detection limit established in phase I in water by lowing the detection limit by factor of 10 (Threshold) to 1000 (Objective).
Minimize detection time for the assay (time to result; Threshold 8hrs, Objective less than 2hrs). Shelf stability of included reagents without refrigeration or other controlled environment will be addressed (shelf-life threshold 1 year, objective 5 years). Complete construction of full-scale prototype system meeting metrics for size (handheld), weight (Threshold 5 lbs., Objective 3 lbs.) and run time before recharge (i.e., battery life; Threshold 10 hr, Objective 24 hr) requirements.
Provide a report, associated drawings and control software/source code, if applicable, documenting the theory, design, component specifications, performance characterization, projected reliability/maintainability/cost and recommendations for technique/system implementation. Deliver a high-fidelity full-scale prototype, consumables, and user guide to support joint Warfighter technical, operational, environmental and safety testing in the target application by the end of Phase II.
An updated production cost analysis shall be completed and design for manufacture considerations shall also be projected to support advancement of TRL and associated Manufacturing Readiness Level (MRL). An implementation plan shall be provided for the scalable warfighter sustainment (food and water) sensor system and reagents for use by the joint expeditionary force.
The Phase II prototype shall support operational testing that validates the feasibility of the approach and can ultimately support transition to military and commercial applications (Phase III). The projected technical readiness level shall be a TRL 6.
Phase III
The proposed technology innovation and associated manufacturing capability will overcome the present technology gap and be rapidly transitioned to both military and commercial applications. The anticipated product is a self-contained, rapid, easy to use, shelf stable assay as part of an ideal detection platform for field use by expeditionary forces, as appropriate.
The detection system in this phase will be a fully operational single process unit. The Phase III is expected to advance the proposed innovation to a TRL of 7 or higher, supporting a system demonstration in a relevant environment in the hands of the Soldier. Ultimately, the technology will be transitioned to the Squad or individual Warfighter, where high efficiency, long life, and low-cost technology is needed. This will maximize the performance, lethality and security of the Warfighter by ensuring safe and optimum hydration and nutrition in all operating environments.
The Phase III represents concurrent (unfunded) commercialization of the technology that is expected to provide economy of scale, logistic, and other benefits that can be attributed to the proposed development. This technology will transition to Joint Project Manager Medical Countermeasure Systems – Diagnostics (JPM-MCS-dX) or Product Manager Soldier Clothing and Individual Equipment (PdM-SCIE). Commercially, this system can be used for rapid, simple identification of pathogens in food and water that may be contaminated with multiple pathogens. The system may also have potential use in point of care diagnostics for these targets in a medical environment.
Submission Information
Please refer to the 23.B BAA for more information. Proposals must be submitted via the DoD Submission site at https://www.dodsbirsttr.mil/submissions/login
References:
- Expeditionary Advanced Base Operations (EABO) Handbook, Ver. 1.1,1 June 2018
- Commandants Planning Guidance, 38th Commandant of the Marine Corps, 2019
- Bülbül, G., Hayat, A., & Andreescu, S. (2015). Portable Nanoparticle-Based Sensors for Food Safety Assessment. Sensors (Basel, Switzerland), 15(12), 30736–30758. https://doi.org/10.3390/s151229826
- Yanli Lu, Zhenghan Shi, Qingjun Liu, Smartphone-based biosensors for portable food evaluation, Current Opinion in Food Science, Volume 28, 2019, Pages 74-81, ISSN 2214-7993, https://doi.org/10.1016/j.cofs.2019.09.003
- Putnam SD, Sanders JW, Frenck RW, et al. Self-reported description of diarrhea among military populations in operations Iraqi Freedom and Enduring Freedom. J Travel Med. 2006;13(2):92-99. doi:10.1111/j.1708-8305.2006.00020.x
Objective
Develop a multiplex detection system that can be used by an expeditionary force for the detection of pathogens in food and water using shelf-stable nanotechnology enabled assay.
Description
U.S. troops are deployed worldwide to places where commercial food sanitation standards may be inferior with poor enforcement. Survey data of military personnel deployed in Iraq or Afghanistan reported high rates of diarrhea, 70 and 54% respectively, for respondents. Higher rates in deployed personnel in Iraq was attributed to more access to local foods (26.6% in Iraq reported eating local food weekly compared to only 5.3% in Afghanistan).
There is significant risk to Warfighters consuming local food or water that contains pathogens. Pathogens can be naturally occurring or intentionally introduced. Current methods to detect pathogenic contamination in food/water such as culture counting, molecular diagnostics, and ELISA like assays require reagents with limited shelf-life, cold storage requirement, trained users, multiple manual steps, and long wait times. This topic seeks to utilize detection technologies to protect Warfighters from incidental or intentional contamination by verifying the safety of food/water.
Reducing the logistical burden associated with acquiring safe food and water will maintain expeditionary posture on extended missions up to 7 days without resupply as part of multi-domain operations.
Current detection systems for food/water pathogens require multiple pieces of equipment for a pre-enrichment/concentration of target in the food sample followed by multiple steps to isolate the pathogen from the sample matrix. These procedures increase the testing time and ultimately extends the overall time to response.
In addition, cold chain logistics is a key resource limiting factor that directly affects reagent stability and is not feasible for the expeditionary force. Recent advances in biotechnology, synthetic biology, nanotechnology, and artificial intelligence/machine learning provide opportunity to overcome many of these limitations and hurdles. The proposed concept would utilize a single hand-held test device that can provide a yes/no determination of food and water safety without the use of other supporting equipment elements in a resource limited environment.
This system would be capable of targeting enteric viruses, parasites, and bacteria. Viral targets would include Hepatitis A, Norovirus, Poliovirus, Rotavirus and Coxsackievirus. Parasite targets would include Giardia, Cryptosporidium, Schistosoma, Entamoeba histolytica and Cyclospora. Bacterial targets would include Shiga Toxigenic Escherichia coli (STEC), Listeria monocytogenes, Salmonella, coliforms and Campylobacter.
The overall size and weight of the system should be man portable with the objective of each individual component to be hand-held (threshold total system weight of less than 5lbs with the objective weight of less than 3lbs).
Stability of the system and reagents will need to be compatible with non-controlled environmental conditions to include extremes in temperature (low -40°F, high 160° F), freeze-thaw cycles, wide range of moisture condensing and non-condensing (RH% 10 to 90%). Shelf stability of reagents in the test kit is necessary and must not expire for at least one calendar year.
System will provide a rapid (threshold time to response < 8 hrs, objective time to response < 2 hrs) yes/no determination of safety without the need for user interpretations. An internal positive control and negative control for system readiness and test reagent verification will also be key requirements of the final system.
Phase I
Design and develop a proof-of-concept unit capable of demonstrating the performance requirements and metrics outlined above. Establish the feasibility, usability and practicality of the proposed design and materially demonstrate and validate the concept through preliminary testing. For Phase I the detection system would have to show the ability to detect one target from each group (virus, bacteria, and parasite) in water on a single test kit without using supporting laboratory equipment.
Detection of the targets would occur at levels that are high enough that enrichment would not be needed for bacterial targets. Detection system in this phase will be a breadboard unit. A preliminary cost analysis must be completed based on projected scale-up and manufacturability considerations. A final report shall be delivered that specifies how requirements will be met (including mitigation of risks associated with factors limiting system performance).
The report will detail the conceptual design, performance modeling and associated drawings (CAD or Solidworks® format), scalability of the proposed technology with predicted performance, safety and human interface (MANPRINT) factors, and estimated production costs. The projected technical readiness level (TRL) shall achieve a TRL of 3 and provide a clear path to Phase II/III and follow-on commercialization.
Phase II
Refine the technology developed during Phase I in accordance with the goals of the project. Fabricate and demonstrate a high fidelity, full scale, advanced prototype for the target warfighter application, verifying that the desired performance is met. Expand detection to the other four organisms in each group that were not addressed during Phase I. Phase II will also include sampling of food matrices for all of the pathogens in each group. Food samples will include spinach, strawberries, and ground beef. Phase II will also maximize sensitivity improving on the detection limit established in phase I in water by lowing the detection limit by factor of 10 (Threshold) to 1000 (Objective).
Minimize detection time for the assay (time to result; Threshold 8hrs, Objective less than 2hrs). Shelf stability of included reagents without refrigeration or other controlled environment will be addressed (shelf-life threshold 1 year, objective 5 years). Complete construction of full-scale prototype system meeting metrics for size (handheld), weight (Threshold 5 lbs., Objective 3 lbs.) and run time before recharge (i.e., battery life; Threshold 10 hr, Objective 24 hr) requirements.
Provide a report, associated drawings and control software/source code, if applicable, documenting the theory, design, component specifications, performance characterization, projected reliability/maintainability/cost and recommendations for technique/system implementation. Deliver a high-fidelity full-scale prototype, consumables, and user guide to support joint Warfighter technical, operational, environmental and safety testing in the target application by the end of Phase II.
An updated production cost analysis shall be completed and design for manufacture considerations shall also be projected to support advancement of TRL and associated Manufacturing Readiness Level (MRL). An implementation plan shall be provided for the scalable warfighter sustainment (food and water) sensor system and reagents for use by the joint expeditionary force.
The Phase II prototype shall support operational testing that validates the feasibility of the approach and can ultimately support transition to military and commercial applications (Phase III). The projected technical readiness level shall be a TRL 6.
Phase III
The proposed technology innovation and associated manufacturing capability will overcome the present technology gap and be rapidly transitioned to both military and commercial applications. The anticipated product is a self-contained, rapid, easy to use, shelf stable assay as part of an ideal detection platform for field use by expeditionary forces, as appropriate.
The detection system in this phase will be a fully operational single process unit. The Phase III is expected to advance the proposed innovation to a TRL of 7 or higher, supporting a system demonstration in a relevant environment in the hands of the Soldier. Ultimately, the technology will be transitioned to the Squad or individual Warfighter, where high efficiency, long life, and low-cost technology is needed. This will maximize the performance, lethality and security of the Warfighter by ensuring safe and optimum hydration and nutrition in all operating environments.
The Phase III represents concurrent (unfunded) commercialization of the technology that is expected to provide economy of scale, logistic, and other benefits that can be attributed to the proposed development. This technology will transition to Joint Project Manager Medical Countermeasure Systems – Diagnostics (JPM-MCS-dX) or Product Manager Soldier Clothing and Individual Equipment (PdM-SCIE). Commercially, this system can be used for rapid, simple identification of pathogens in food and water that may be contaminated with multiple pathogens. The system may also have potential use in point of care diagnostics for these targets in a medical environment.
Submission Information
Please refer to the 23.B BAA for more information. Proposals must be submitted via the DoD Submission site at https://www.dodsbirsttr.mil/submissions/login
References:
- Expeditionary Advanced Base Operations (EABO) Handbook, Ver. 1.1,1 June 2018
- Commandants Planning Guidance, 38th Commandant of the Marine Corps, 2019
- Bülbül, G., Hayat, A., & Andreescu, S. (2015). Portable Nanoparticle-Based Sensors for Food Safety Assessment. Sensors (Basel, Switzerland), 15(12), 30736–30758. https://doi.org/10.3390/s151229826
- Yanli Lu, Zhenghan Shi, Qingjun Liu, Smartphone-based biosensors for portable food evaluation, Current Opinion in Food Science, Volume 28, 2019, Pages 74-81, ISSN 2214-7993, https://doi.org/10.1016/j.cofs.2019.09.003
- Putnam SD, Sanders JW, Frenck RW, et al. Self-reported description of diarrhea among military populations in operations Iraqi Freedom and Enduring Freedom. J Travel Med. 2006;13(2):92-99. doi:10.1111/j.1708-8305.2006.00020.x