1. Hospitals and potential MDD patients are our end users.
(Who are your proposed end users?)
Because this method of MDD diagnosis by detecting miRNA in blood is simple and fast, and does not require expensive equipment, it is used by hospitals that have opened MDD treatment, especially in remote areas or hospitals with poor resources, as well as by potential patients who are unwilling to go to hospitals and are worried about their emotional privacy being exposed.
2. The blueprint of hospital and potential patients using our project.
(How do you envision others using your project?)
When a potential depressive patient goes to the hospital for medical treatment, the doctor makes preliminary inquiries. When it is possible to diagnose MDD, three specific miRNAs can be detected at the same time during routine blood testing. This detection method is relatively simple and fast.
A drop of blood is added to the paper strip sensor, plus the chromogenic substrate (x-gal) in the kit. When there is a color change, compared with the positive control photograph, Obtain the color density values of samples and positive control, and confirm the diagnosis of MDD by relative quantitative comparison. Because the detection method is simple and does not need expensive equipment, objective diagnosis of MDD can be made in hospitals, especially with poor medical conditions and remote hospitals.
If they are potential patients with MDD, they do not want to go to the hospital and worry about privacy exposure. They can also use iodine or 75% alcohol to disinfect their hands at home or in places they think are hidden.
After that, they break their fingers and take a small amount of blood from their fingers, drop it on the paper strip sensor, and then add the color developing substrate (x-gal) in the kit. When there is a color change, they can take photos through cell phones, compared with the positive control photos, combined with the matching cell phone APP small software, obtain the color density values of the samples and positive controls, and compare the results on the instructions to diagnose whether they have MDD.
3. Implement our blueprint in the real world.
(How would you implement your project in the real world?)
We first constructed and optimized the components of the paper strip sensor detection kit, including the construction of a cell free reaction system, the amount of positive control, chromogenic substrate (X-Gal), hand disinfectants (iodine and 75% alcohol), the handheld detector, the two-dimensional code downloaded by cell phone APP software, also including the detailed operating instructions for the reaction temperature range, as well as the visual chart for obtaining the comparison of the color density values of the detection reaction.
Furthermore, the detection kit is divided into two categories. One is for hospital use and the other is for personal use. For the kit for personal use, consider hand disinfection method, the needle that punctures the finger and the closed suit after use to avoid hurting others. Add detailed instructions in this kit.
Another important thing is to optimize the paper strip sensor to make it more intuitive and convenient (Fig.1).
Fig. 1 The optimized paper strip sensor model for MDD diagnosis.
It is necessary to popularize and publicize the use of miRNA as a diagnostic method for MDD. A training class on MDD diagnosis and other promotional activities were held. The audience may be doctors, laboratory technologists, and interested people. By making speeches about the comparison of various methods of MDD. The method by using miRNA as marker to diagnose MDD was accurate, fast, low cost, and did not need expensive equipment, to help them understand and make the audience convinced.
At the initial promotion in hospital, it is necessary to introduce the method of MDD detection to doctors, comparing with the current diagnostic results in hospital, and to obtain the correct rate of diagnosis with mutual verification. It could obtain the trust of doctors and potential patients, which are important factors in application of our detection method.
Cell advertising is very necessary for individuals. Cell phone advertising is implanted to enable potential MDD to obtain the method and kit for diagnosis through their cell phones, which could tell them that our MDD detection kit is convenient, fast, low cost and accurate, making them believe it.
4. Safety is very important in our consideration.
(What are the safety aspects you would need to consider?)
For potential MDD who go to the hospital for examination, there is no potential safety hazard in the operation of extracting a small amount of peripheral blood, which is a routine operation in the hospital.
It is only for personal use that he needs to use a needle to pierce his finger. The standardized operation of hand disinfection and treatment of the needle after use should be considered for safety. The detection kit contains a sealed box for collecting needles (Fig.2) and a detail instruction.
Fig.2 Pictures of self blood collection
5. The challenges in our consideration.
(What other challenges would you need to consider?)
The challenge faced by our MDD detection kit is evaluating the pathological grading of depression by detection results, and determine whether it is a primary, moderate, and severe depressive patient. This is where improvement is needed in the future.
It is suggested to cooperate with the hospital to continuously optimize the corresponding relationship between the test results and the patient's condition, and gradually improve the hierarchical report of the test results through large sample data.