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Revision as of 13:59, 29 October 2017
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Safety
Lab Safety
Personal safety is very important in the workplace, we ensured high standards were met.
To read more click on each icon below.
Safe Project Design
Safe Product Use
Experiment Problems
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The use of genetically modified organisms (GMOs) in the field of healthcare
There is a fear factor to consider when thinking about using GMOs in health care. GMOs have had bad media coverage and so you have to consider the acceptance of the new technology with its target user.
(Another issue we may have is that biosafety, biosecurity and dual usage are all the same word in spanish (bioseguridad) so we will have to be careful when discussing this with our target audience.)
Our system will be cell free so there will be no GMO’s present in our final device. In terms of regulation there are less barriers to this technology. However in some areas anything that is labelled as synthetic biology may be seen as the same thing as GMOs, so we must be careful in how we market our device so that patients are not put off.
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- Problem:
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The use of cruzipain to test our system in a proof-of-concept
Cruzipain is a pathogenic protein so it would be dangerous to use in the lab. It is also hard to obtain.
We will be using TEV instead for proof of concept, in order to best ensure our safety as well as get meaningful data. TEV has the added benefit of being a well characterised and widely used protein (so could be more reliable?).
Applied Design Problems
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The distribution of needles in our initial kit could be problematic due to the chances of reuse which can lead to the transmission of diseases. Also the misuse of/inability to use needles if this were to be a home kit.
If a fairly large sample of blood were needed it would require the test to be done by a trained medical professional. This would mean that the distribution of the kit to more rural areas would be limited as not all places have access to doctors or nurses. If only a finger prick were needed then it could be done by the patients themselves and distributed to villages.
We have decided to move away from the home kit idea and since our test now focuses on congenital Chagas disease it will be done in a hospital or maternity clinic with a medical professional present. This would ensure that any blood needed would be taken in a safe way. .
‘FIND’s goal is to support intensified global control efforts through the following specific objectives: To reduce the burden of congenital Chagas disease through improved diagnostic solutions’ - (https://www.finddx.org/wp-content/uploads/2016/02/NTD_Strategy_WEB.pdf)
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Medical infrastructure in the places worst affected by Chagas disease face complex challenges so the chance for follow ups or distributing results is not perfect. .
a point of care diagnostic would be better
We will try to make our diagnostic one that is at the point of care at birth. This would enable a diagnosis to be give straight away and treatment plans set up as soon as possible. Through modelling we have found that our test takes [INSERT TIME HERE] to work This would also help with the distribution of our test as hospitals are more accessible with supplies.
‘For congenital Chagas disease, the best time for parasitological or molecular diagnosis is during the first few weeks after birth when parasitaemia is often high. This is difficult, however, due to limitations in infrastructure and resources. As a result, children born from infected mothers have to wait for up to ten months after birth before they can be tested by serology (serological tests are only useful after maternal antibodies have waned). Many children are thus lost to follow-up during this waiting period. A point-of-care test for congenital Chagas disease to enable testing of neonates at the place of birth would ensure early detection and safer treatment.’ - FIND Strategy for neglected tropical diseases 2015-2020 (https://www.finddx.org/wp-content/uploads/2016/02/NTD_Strategy_WEB.pdf)
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The more sensitive our system is the more likely we are to get false positives due to the amplification system we have.
False positives could have an impact on the mental wellbeing of patients, and can also lead to administering expensive drugs and treatments when they are not needed and could lead to uncomfortable side effects for the patients.
Our device will only be for screening, and will be integrated into our recommended plan of action to diagnose and treat congenital Chagas disease. This can be viewed by clicking here.