How the L.A.S.S.O. fits into The Lung Ranger

The biological detection systems are potentially capable of detecting the presence of the bacterial species forming the focus of our project. However, it is unlikely to be capable of generating a quantifiable measure of bacterial load if used in isolation. Indeed, even a qualitative output from the systems would require it to be used in conjunction with sophisticated laboratory equipment. We therefore created the Light Amplifying Signal Sensing Object (L.A.S.S.O.) - a device, when used in conjunction with the systems, is potentially capable of quantifying the bacterial load by utilising the biophotonics phenomena. The L.A.S.S.O. would allow for more frequent mobile monitoring of lung infections in CF patients, offering early detection and thus improved treatment, quality of life and ultimately, survival.

Aims

The main aim was to design a relatively inexpensive device that would be easily used with little training, thus making it a device that both medical staff and patients alike would be comfortable in using. In the future, the device should be capable of being used away from the clinic.

• To show people on the front line in the battle against CF lung disease (medics and patients) how the Dundee iGEM project can be used in the real world.
• The possibility of this having a lasting benefit, not just to provide much quicker diagnosis times, but ultimately giving control back to the patients .
• Building a bridge between synthetic biology and the people it can help by having patients and health care professionals be part of the design of the L.A.S.S.O

Objectives

• To build a device able to detect the low light levels produced by the E.coli and quantify this signal with known standards to calculate the amount of bacteria present.
• To design a computer application able to relay the amount of bacteria present to a downstream user (e.g. Doctor).
• To design a computer application which can simulate how the L.A.S.S.O. could be used in the real world - showing how information could be easily shared between patient and medical staff (automated, letting the technology do the work).

Methodology

To build the best device possible we took a professional approach to our design and development processes.

User based approach

The L.A.S.S.O. is more than just the development of an idea; we wanted to see whether this device could be realistically implemented in society. To create a product that had a future in the real world we decided it would be best to talk to people we envisioned using it. People who understand the daily struggles and realities of treating cystic fibrosis. So we took a customer based approach by meeting with patients and medical staff to hear their view on how the L.A.S.S.O. should be designed to best meet their needs.

ISO Standards

After obtaining a clear direction for our device from possible future users we spoke to members of industry. In particular we contacted a local company that developed medical equipment; the Institute of Medical Science and Technology. From this we found that the main body for devising procedures by which medical devices should be built is the International Organisation of Standards (ISO). As we live in a global community where such standards are important to ensure that “products and services are safe, reliable and of good quality”¹ there are strict procedures that must be adhered to. During the development of the L.A.S.S.O. we attempted to apply as many of the points given in the quality management standards 13845 as we could. Standard 9001 dictates the procedures for general quality management; giving standards a company should follow when developing a product. Standard 13485 expands on 9001 to specify how a medical device should be developed.

This all led to us completing documentation to show how we were meeting the users needs - a requirements document; giving us the final aims of how the L.A.S.S.O. would operate and the functionality involved. It was an iterative process with the documentation being updated after feedback from our supervisors, patients and medical staff. A procedure that was in line with the ISO standards.

The first iteration can be downloaded here, and contains the version of the L.A.S.S.O. as if it were tested with the biological detection in place which produces a bioluminescent output. The second iteration can be downloaded here, and was used alongside our prototype device with tests based on luciferase production from Vibrio fischeri and does not involve the Lung Ranger biological detection systems.