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Team:Dundee/Implementation/realWorld
From 2014.igem.org
Real world
Taking Its First Steps
User Feedback
Since the L.A.S.S.O. was designed using input from the CF community we wanted them to let us know how well it worked. It was essential to the team that possible future users could use the prototype. Therefore, we took the L.A.S.S.O. back to the our local CF clinic in order to get possible future users to have a go at testing the device.
Michael, a Cystic Fibrosis patient, gives his view on the L.A.S.S.O.;
Dr Rogers giving her views on the L.A.S.S.O. Interface;
Audit
We had an ISO 13485 certified auditor look through our documentation for the L.A.S.S.O. and perform a mock audit to highlight any additional steps we could take to have a product that is as industry-ready as possible. In addition to receiving suggestions about how to improve our documentation (which have been acted upon) we were informed of the following:
In Europe, to obtain a CE mark there are three devices directives:
- Medical Device Directive
- Active Implantable Device Directive
- In Vitro Diagnostics (IVD) Directive
A product life cycle is split into stages:
- Proof of concept/Feasibility
- Optimisation
- Verification
- Validation
- Launch
- Post Market surveillance
- Withdrawal from the market/end-of-life
The audit concludes with some general questions on the use of the device. We have answered these below.
Q. Microbiological concerns – are the specimen receptacles single use? How long can they be stored before the bin needs to be emptied? Will all the samples be from the same patient?
A. The receptacles (plates containing our biological components) will be single use and will be emptied from the bin and disposed of following autoclaving on the day of use. The samples will not all necessarily be from the same patient, this will depend on the number of patients being visited in a day. Neither the team nor medical staff have identified any potential issues with this approach.
Q. How will consistency be maintained between device batches?
A. During the manufacture of our receptacles and prior to freeze-drying, each inoculum of our biological component will be measured carefully for optical density and a sample will be assayed for activity in the presence of a synthetic signalling molecule. The latter process would be scaled-down to the minimal reaction size required to give a significant result in order to be economically viable.
Q. What kind of shelf-life/in-use stability are you looking at for this device? How will it be transported and stored?
A. It is difficult to project a shelf–life for this device but based upon the simplicity of the majority of the hardware (plastic casings etc.), if the biennial maintenance checks suggested in our requirements document are carried out for the electronic components, this product will potentially be viable for many years before replacement becomes necessary.
Q. How can an operator check the test is working – will you provide calibrators or controls?
A. Both a positive and a negative control would be supplied with the device. The negative control would be a plate that was identical to all other receptacles except that it would contain no bacterial culture and thus would also function as a reference measurement. The positive control would be a source of light such as an LED which would give a reliable intensity and wavelength of light. The light source should be of a very low light level so that it would be consistent with the level of light produced by the luciferase. The latter could be built in to future versions of the L.A.S.S.O.
Welcome to Dundee's 2014 Wiki (Site Information)
Cystic Fibrosis is a genetic disease that results in the accumulation of thick mucus in the epithelial linings of the entire body, particularly the respiratory tract. Over the course of a patient’s life, the mucus-lined lung epithelium becomes repeatedly infected with pathogenic bacteria that stimulate an immune response; leading to inflammation, tissue damage, and ultimately, respiratory failure.
The microflora of the Cystic Fibrosis lung changes over time. In childhood, the major coloniser is Staphylococcus aureus, but as the patient matures other bacterial pathogens infect. The later-dominating pathogens, Pseudomonas aeruginosa and Burkholderia cepacia, are very difficult to eradicate and are associated with chronic decline in lung function. Burkholderia is so infectious that patients have to be isolated from one another, and can be denied lung transplants due to the persistence of this bacterium.
It is important, therefore, for medics to monitor and identify the levels of bacteria within the respiratory tract of a Cystic Fibrosis patient. Currently, patients must provide sputum samples and identification of bacteria takes between 72 hours and 2 weeks, by which point the bacteria can be in an antibiotic resistant state.
The Dundee 2014 iGEM project is focused on designing and testing a device that will rapidly and non-invasively identify the bacteria colonising a Cystic Fibrosis patient. Three biosensors will be developed that recognise external signal molecules produced by key bacteria, all of which are known to be in sputum samples of Cystic Fibrosis patients. A quinolone signal (PQS) is produced by Pseudomonas aeruginosa, a Diffusible Signal Factor (DSF) is produced by Stenotrophomonas maltophilia, an organism that is also associated with Cystic Fibrosis lung infection in adults, and BDSF is a related, but chemically distinct molecule that is produced by Burkholderia cepacia.
By engineering signal recognition and signal transduction proteins from these biological systems the Dundee iGEM team want to produce a portable electronic device that will identify infection outside of the clinic, so that patients do not have to travel great distances, and can be used to help health professionals make informed and rapid decisions on antibiotic treatments.
Read this again by clicking on Site Information in the navigation bar!
Bulletin Board (Policy & Practice)
Come look at the poster explaining how we involved the local and national Cystic Fibrosis community in our project, how we listened to people on the front line of the disease and how they affected our project.
School (Project)
Come in and learn about all the parts that make The Lung Ranger. The lab work that we carried out over the summer is explained here in detail, along with the modelling and implementation.
Library (Log Book)
Read about the experience the team has had over the summer. A week by week description of our work, how we carried out that work and some photos of our time together.
Saloon (iGEM community)
Come on in, take a seat and learn how we have interacted with the larger iGEM community. Who the team are, who helped them and how we helped others.
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