Team:Calgary/PoliciesAndPractices

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Policies & Practices

Our 2014 project is attempting to tackle the issue of malaria misdiagnosis. When a patient displays febrile symptoms in resource poor and malaria prone countries, it is often common practice to treat with a broad-spectrum antibiotic even in the absence of a positive malaria diagnosis. We propose a multiplexed diagnostic tool capable of simultaneously diagnosing many febrile illnesses.

This is a large and complex issue however, and a thorough grasp of the target market for this multiplexed diagnostic tool is crucial. Our first step was to determine exactly who our target market was. Through interviews with professionals as well as reaching out to various non-profit organizations working in these areas, we have developed a well-rounded understanding of the characteristics required of our device as well as a better understanding of our target market and the needs within.

Diagnostic Landscape

Diagnostic Landscape

We began our research by seeking to understand the current world of diagnostics; how it is successful and what is currently lacking. There is a large amount of literature available on this topic, with many large international organizations pointing to the need for a multiplexed diagnostic tool. These reports helped us to grasp the scope of the issue, as well as helping us to realize the durability features our device must have to be deployable to developing countries.

Informed Design

To best understand the issue at hand, we consulted with many experts. Each of these experts was able to provide guidance in their own unique way, transforming our project into a practical and necessary solution. They helped us to define commonly mistaken pathogens, market feasibilities and regulatory considerations that would need to be taken into account for our proposed device.

Implementation

All diagnostic assays are governed by both local and international legislation and policy. By better understanding the policies that surround such a device we were able to tailor our design and make future implementation a feasible task. These guidelines can be a starting point for future iGEM teams when considering implementation of a diagnostic tool.

Safety

Our final device utilizes an engineered strain of bacillus subtilis to create a colorimetric output. It was important for us to consider the disposal of these devices, and any problems that could arise from the release of our engineered organism. It is also very important for us to analyze any rates of false negative that could be associated with our device for the safety of the user.