Informed Design

To inform the design of our platform, we conducted extensive research in the areas of malarial diagnosis, infectious diseases as well as policy surrounding diagnostic tests internationally. We reached out to many professionals working in various areas to best understand all sides of this issue. We were able to speak with and interview:

Dr. Lisa Allen Scott

Holding a PhD in Population and Public Health, Dr. Allen Scott currently works at the University of Calgary and was a great resource to us when designing our project. As one of our first stops when we were seeking to understand the problem at hand, her experiences were exactly what we needed. Having spent significant amounts of time in rural villages in Tanzania, Dr. Allen Scott investigated a seemingly inflated rate of malaria diagnosis. What she found was that nearly 70% of individuals were diagnosed as having malaria when they actually didn't. She has written several papers on the issue, as well as proposed solutions. Dr. Allen Scott played a huge role in designing a set of desired characteristics that our diagnostic device must have.

Dr. Abebe Bayih

Dr. Abebe Bayih is currently a Post-doctoral fellow working in the department of Pathology and Laboratory Medicine at the University of Calgary. He is currently researching new candidate medications for malaria treatment as well as conducting research in collaboration with the University of Gondar in Ethiopia regarding new and novel diagnostic ideas. Dr. Bayih’s experiences with the detection and treatment of malaria were a very important part of the development of our project. Having a vast amount of experience with antibiotic resistance helped us to better understand this ever changing issue.

Dr. Mofoluwaso Abolarin

Dr. Abolarin worked as a surgeon in Nigeria for 10 years before relocating to Canada where he now serves as a family medical physician. His experiences with treating malaria in low resource areas as well as his personal experiences during time spent there helped us to better understand the difficulties that physicians face in these areas with a lack of diagnostic ability.

Wendy Hutchins

Ms. Hutchins has been actively involved in the iGEM team all year. She became actively involved with our Policies and Practices Team when it came time to discuss the international assay policies that could possibly affect the implementation of our project. She helped us to understand the quality control measures required of our device before it would ever be approved for market.

Derrick Luwaga

A Ugandan native, Derrick has operated the Kyosiga Community Christian Association for Development (KACCAD) since 1994. This organization seeks to provide basic health and water supplies to remote areas within Uganda. KACCAD has recently opened a medical clinic where they administer malaria diagnostic testing. Derrick was able to speak with both the technicians and the physicians who work within the lab conducting malarial diagnosis. He sent us videos of the interviews he conducted, the process involved as well as documenting the available technology and resources. This was an amazing insight to have to guide our project, and to even better understand the needs of the end-user.

Each of these professionals provided insight into different areas of the project. They helped us to better understand the needs in the areas we would be targeting, as well as helping us to recognize potential obstacles.

Device Characteristics

With all of this in mind we determined that our diagnostic tool would need to have the following characteristics:

Adaptable

Our device must be easily tailored to diagnose diseases endemic to a particular area. By simply changing the target sequence within our B. subtilis strain we are able to target different pathogens that might plague different geographical regions. This device could easily have different versions for different areas.

Affordable

It is of utmost importance that our system be attainable by our end user. Although no current multiplexed standard exists, we have used the pricing suggested by the WHO for an HIV assay, which has a final device cost of no more than $10USD. Our consultation with the Foundation for Innovative New Diagnostics (FIND) helped us realize the number of taxes that will be applied to our device, essentially doubling its original cost. For this reason we seek a final device price of no more than $5 per device. Our cost analysis found that our device could be manufactured on a large scale for less than $2.

Robust

Our final device must be able to withstand transport as well as harsh environmental conditions. To make our device as robust as possible, we have used B. subtilis spores. These spores can withstand extreme heat and cold before their rehydration, and provide us with the necessary shelf life required by the World Health Organization (2 years).

Easy to Use

Not all rural clinics have trained technicians. For this reason our device must be simple, requiring very little expertise. In addition, our device overcomes language barriers by displaying only colorimetric results. These results are clear and defined, leaving little room for misinterpretation.