The challenge

Background and context

Biothreats, such as certain viruses, bacteria, and toxins can be considered weapons of mass destruction, and have been employed in both terrorist attacks and warfare. The ability for DND/CAF and safety and security government partners to identify biothreats in an environment collected from a variety of sample types such as swabs, soil, liquid, bodily fluid, etc., as well as to monitor when the risk has decreased (i.e., when the concentration of biothreat or contaminants is below an acceptable threshold) will dictate how they manage the environment.

When responding to a scene, a lab with highly trained technicians and equipment with precise temperature control for processes or reagent storage is not always readily available. Samples need to be taken by the response team, analyzed with minimal sample preparation and hands-on time, and a presumptive result produced quickly, often in the field or a temporary space.

Most existing bio-identification technologies use a targeted approach to test whether a specific threat pathogen or biothreat agent is present in the sample. There is always a risk of novel agents being developed and dispersed, and a targeted approach limits the ability to detect these new or otherwise unanticipated biothreats. Thus, a means of agent-agnostic identification of the biothreat in the field is highly desirable. Additionally, an adaptive approach which could provide a rapid initial identification of the general biothreat class, to be further characterized downstream, may be an option.

The systems currently used by DND/CAF and safety and security partners for identification of biothreat agents are field-deployable polymerase chain reaction (PCR)-based assays or lateral flow assays that test for key pathogens. While the current PCR-based solution has offered satisfactory automation, ease of use, sensitivity (true positive rate) and specificity (true negative rate), there are opportunities to improve on existing platforms such as decreasing reagent cost, increasing shelf life, expanding targets, or making the test agent agnostic, and for novel approaches and technologies to be developed, automated, and commercialized.

Essential outcomes

We are looking for innovative solutions for identifying high consequence biothreats, which can be developed into an automated, fast, and easy to use field-deployable system, with low operating and consumable costs.  
Proposed solutions must address the following:

• Stand-off detection or automated sample preparation (such as sample weighing, extraction, filtration, dilution, transfer to analysis devices, etc.);
• Ability to handle multiple matrices (atmospheric mixing, fluid, swab, environmental samples, etc.); and
• Agent agnostic identification and/or rapidly adaptable method to non-traditional targets.

Desired outcomes

Proposed solutions should include capabilities and considerations such as, but not limited to the following:

• Sensitivity and specificity (true positive and true negative rates) better than or equivalent to conventional nucleic acid amplification methods.
• Ability to identify multiple high consequence pathogens in a single sample.
• Ability to test multiple samples at once.
• Fast with preliminary results in one hour or less (depending on analysis and certainty).
• Miniaturized to reduce the volume of sample and reagents required.
• Small footprint (i.e., for use in hot zone or a mobile lab).
• No cold chain requirements.
• Equivalent or longer kit shelf life than what is currently on the market (typically one (1) year).
• Cost per sample of $200 or less.
• A system that safely contains and preserves a portion of the sample for additional downstream analysis and/or archiving.