Proposed Implementation
AptaTear is a diagnostic kit that is intended to be used by healthcare professionals to ensure efficient detection of minor traumatic brain injuries (mTBIs) in a patient. This kit would be easily accessible for medical staff in hockey teams and other contact sports where head injuries are common. The kit would come equipped with the necessary reagents for the reaction to take place, meaning the medical staff only need to take a sample of tears from the athlete (and/or patients), and add to a test tube that will be included in the kit. The solution would then require warming. It can be assumed that almost all sports arenas or training grounds lack PCR machines; therefore, a substitute is needed. A thermos or some sort of heating block can be used as a heating source, since maintaining the temperature at a certain level is not required, and it is enough for a reaction to occur. With the help of AptaTear, athletes can make sure that they are not exposing themselves to more danger by continuing the game/training with a brain injury. During a sports competition, the game could potentially be put on hold while the kit is being used. Once results can be read, the athletes ability to continue the game can be evaluated, to ensure the safety of the athlete.
The kit is also thought to be used in ambulances or in emergency service, as seen in the image below
This makes sure that the medical staff at the hospital gets a well needed head start when it comes to giving a diagnosis of the injury, which saves valuable time!
A possible real world implementation process would begin by obtaining a patent for our product, to prevent the possibility of illegal distribution. As well as discussions with hospitals for the prospective partnership, allowing AptaTear to have a reliable customer with proper usage. Afterwards, contact with the Swedish Medical Products Agency regarding the required license, such as the manufacturing license and transportation. Furthermore, the manufacturing area should be considered and decided. Production of necessary components, such as amplification mix, ligation mix, and other necessary components would have to be done by us. However, since this is a medical product, this would be a lengthy process. Additionally, increasing the public’s awareness on mTBIs is needed. If the public, especially sports coaches and referees, are not aware of mTBIs, one of the main end users would disappear.
Current challenges the team must consider and discuss is how our detection kit, at the moment, can only be used by a professional healthcare worker. By developing this project further, the accessibility for the public can hopefully increase. Once this is accomplished, the accessibility of AptaTear would allow us to expand our reach to people who lack good access to health care, since the general public would be able to use the product. However, before we can proceed to making our product accessible for the public and expanding to countries outside of Sweden, further safety aspects must be considered and discussed. One reason for this is to reduce the risk of illegal distribution, misuse of product, and dual use. All of these problems would increase when the public could get their hands on them. Therefore, preventative methods must be implemented in the case that the possibility mentioned above were to occur.
When it comes to safety aspects, there are several of them to be considered before the production of our detection kit. For example, the prospective illegal distribution, misuse of our products and dual-use. This is further explained in the safety page.
The future of the kit seems promising. For example, tau is a known biomarker for other neurodegenerative diseases like Parkinson's Disease (PD) and Alzheimer’s Disease (AD) [1]. If the development of the diagnostic kit with tau as a biomarker were to be successful, it could potentially be used for the detection of such neurodegenerative diseases by using a non-invasive, and easy-to-use method. As of right now, the kit is specific to tau, but in the future, it could be expanded for more biomarkers in tears. A requirement of this expansion would be to find specific aptamers for those biomarkers. This would allow for a non-invasive diagnosis of even more diseases than before.