BME100 s2017:Group5 W8AM L2

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Name: Anisa Ahamed
Name: Jenna Forrey
Name: Smita Gopalakrishnan
Name: Matthew Grudza
Name: Fernanda Nunez
Name: Luis Paez


Device Image and Description

Casing for HIV Q-Tip

The cotton swab HIV/AIDS Test is composed of two distinct features: the cotton swab and the plastic casing. The first image displays the cotton swab applicator of the HIV/AIDS test, which will be used to swab the inside of the mouth for saliva. The second picture displays the plastic casing that contains the cotton swab in order to protect the cotton swab from external contaminants.

Technical and Clinical Feasibility

Technical Feasibility

a. What are the technologies needed?

The design provides a simple and feasible technology using nanotubes, enzymes, and chromogen. There have been many advances in technology using graphene in saliva testing, and with nanotubes also being carbon based. This creates a reliable source for HIV/AIDS testing through saliva. Although nanotubes and graphene are both carbon based, the nanotubes are carbon atoms rolled into tubes. This in not the case for the graphene, however, since it is composed of a thick layer of carbon atoms. When discussing the design of the Q-tip, it would be better to incorporate nanotubes into the structure of the Q-tip than graphene because nanotubes would be easier to shape into the round shape of a Q-tip. This is because graphene is flat and must be layered in order to show a significant thickness since a single layer of graphene is about 1 atom thick. Graphene has currently been under testing for glucose test strips, using the carbon atoms, which are coated in platinum nanoparticles. By coating the graphene with the enzyme glucose oxidase, which coats the platinum, the graphene is able to bind with glucose in the saliva and turn it into peroxide. This causes an electrical signal to run through the platinum nanoparticles into the glucose monitor. Using this same technique, it is possible to apply nanotubes into testing for HIV/AIDS. With the design of the Q-tip product, it can be established that nanotubes are superior to graphene because of the basic shape. Tubes can more easily be formed into the oval shape of the top of a Q-tip, which is easier than trying to achieve the same shape by using flat graphene. Because the edges of nanotubes are unbonded carbon atoms, they can easily bond to many structures. The technique of antibody covalent immobilization can then be applied. Because of this, when nanotubes come into contact with the antibodies for the HIV/AIDS virus in the patient’s saliva, they can bond with the antigen on the nanotubes. For this purpose, multi and double walled nanotubes would be used to create more surface for testing. To get the antigen to bind to the nanotubes, the nanotubes would be coated with the enzyme alkaline phosphatase or horseradish peroxidase, and the antigen would bind on top of that. With the structure of nanotubes, chromogen can be incorporated to cause the color reaction results in testing. This is similar to the in-lab ELISA test, which also reinforces the claim of the Q-tip product not only working, but also being accurate.When the saliva from the user first comes into contact with the nanotubes, the antibody from the patient will bind to the antigen/enzyme surface. After this, a 30 minutes wait period is implemented so the chromogen can effectively and fully react. This happens because when the antibodies from the patient bind to the antigen and enzyme, the chromogen substrate reacts with the enzyme and changes color if the pathogen is present.

b. What are the challenges?

The main challenge with our design is incorporating the antibody detector and the testing solution within the same material. In order for the design to work, the antibody detector must be able to mix with the testing solution to display the results of the test. In this design, this process is required to occur in the space of the tip of a cotton swab. Another challenge is how the results are going to be displayed. For the test to display accurate results, the solutions on the tip must mix and change the color of the tip of the cotton swab red if positive. Getting these solutions to combine together to achieve what we want all at the tip of a cotton swab is the biggest challenge. Lastly, making a test that is accurate is also a challenge. This test will not be useful if it is not accurate, so making sure that it will be as accurate as possible with this small of a sample size will also be a challenge.

c. What could go wrong?

Since its is a non-invasive device, the main complications the device can present is a misdiagnose having a false positive or negative for the presence of HIV/AIDS. This can be dangerous, however, if a patient who has HIV/AIDS believes that they are clean from the disease and abstain from getting further treatment to intervene with the progression of the disease. A person who does not have HIV/AIDS may also receive a false diagnosis for HIV/AIDS. Regardless of one’s diagnosis, it is vital for one to receive testing a second time in order to confirm their diagnosis, typically in a clinical setting. However, the people in the demographic to which we are appealing, (poor, African countries), may not have access to clinical care. Because our design is so cheap, however, one may be able to test him or herself several times in order to better confirm his/her diagnosis.

Technical Feasibility Rating

This design would earn a 2 for technical feasibility. This is not a brand new design or concept and the materials that are needed have already been discovered and implemented. The main challenge is figuring out a way to combine the antibody tests with the solution it will mix with to show results all on the tip of a cotton swab. This will be the most difficult technical challenge, but is completely feasible to solve. Other than this, all aspects of our design are quite simple when it comes to technology. Once this one challenge is solved the device will be able to be manufactured.

Clinical Feasibility

a. Will it work in the clinic?

Our design would earn a 2 on the clinical feasibility scale. This means that “clinical success is likely, but will require clinical expertise and/or research.” Although our design is a fairly simple one with a straightforward function and design, there is still room for error and there needs to be testing in order to confirm the validity of the accuracy of our HIV/AIDS testing product. A clinical feasibility rating of 3 would indicate that our product has a clear path for success and that many have tried our method and been successful with their results. However, since our design has not been tested in a clinical setting, it would be inaccurate to determine its clinical feasibility as a 3.

b. What are the clinical risks?

The design of the cotton swab HIV/AIDS testing kit is noninvasive and nontoxic. Because of this, there is little to no clinical risk when considering the safety of a patient. A patient is to use the testing kit by swabbing the top of the cotton swab on his or her gums. The cotton swab, which is coated with a solution of graphene with an HIV/AIDS antibody detector, is designed to change color based on the presence of the antibody within one’s saliva. Even if results are inaccurate for the product, the clinical risk is small since a wrong diagnosis of the HIV/AIDS disease represents the worst case scenario.

c. Have similar products been in a clinical trial? How long was the trial?

A clinical trial reviewed in the article of Jyoti, Bhuvan, that consisted of “ a study group comprised of 50 HIV seropositive subjects and the control group comprised of 33 seronegative subjects.” compares the accuracy of ELISA popular test and the detection of HIV by oral mucosa. This study yields similar results for both mechanism and revealed 100 percent sensibility for all patients, whether on antiretroviral therapy or not. Also, similar products such as OraQuick HIV Home Tests are already existent and in the market which means they’ve already made it past FDA approval. Its Date of Panel Recommendation was was May 15, 2012 and its Date of Notice of Approval to the Applicant was July 3, 2012

Clinical Feasibility Rating

The biomedical device would earn a 2 for clinical feasibility. This means its clinical success is likely but some expertise or research may be necessary for its best implementation. Its success is likely mainly for two factors. The first one is the test method it uses, namely using the antibodies of the oral fluids and, by an enzyme reaction, detecting its relation with HIV / AIDS. This testing mechanism has been reliable as the patents and clinical trials reflect, and the results have been reported to be as higher than 90 percent accurate. This leads to the second reason that is the presence in the market of similar devices, such as OraQuick, that rely on the same mechanism and have reported a higher clinical feasibility. Since our device may differ in minor aspects from the existing devices, especially for the sake of reducing its cost, it will require some further development that cause not earning a 3 for this category. Also, the small number of the subjects on the clinical trials may suggest the need for its testing in a bigger sample population.

Market Analysis

Value Creation

It gives the possibility of a HIV / AIDS diagnosis for a low-cost price and with no need of other clinical equipment, assistance or laboratory analysis. This last point is especially relevant, as the target users of the device are from poor countries with no accessibility to quality health facilities, or trained personnel that evaluate their samples. Also, this self-test system provides privacy, a crucial concern found in people that test for HIV, since it needs no assistance from anyone else and the intuitive display of the results 1 can be distinguished by most of the users.

Manufacturing Cost

The total cost of the design is planned to be less than $1.39 per product. It will cost $0.75 for the nanotubing required for each cotton swab, $0.06 in paper spindle, and $0.58 in recycled plastic for the casing.

Sales Price

$12.51 for individuals, and $4.17 for companies and organizations. These prices were decided through the rule which states multiply the cost of production by 3 to get the price to sell to companies, than multiply that price by 3 to get what consumers will have to pay.

Market Size

Market Size (Lab Report 1) Cost of product * 3 * 3 * Total population interested in product (US Market) $1.39 * 3 * 3 * 317,700,000 = $3.97 * 10^9.

Fundability Discussion

Although there are existing home HIV/AIDS Tests, what makes the cotton swab HIV/AIDS testing product unique from the rest is its significantly cheaper cost compared to other methods of HIV/Aids testing. The countries that suffer from the most HIV cases are located in rural communities around Africa where there is a lack of clinics and a lack of money, which indicates that the current at-home testing kits available are too expensive for an average African civilian. The cotton swab HIV/AIDS testing product is not only intended for those living in the rural areas but also making it more cost effective for anyone who is willing to get tested. The cotton swab HIV/AIDS testing product would not only cost less but would also be less time consuming than making a trip to the doctor’s office. Because of the technology used to design our test it would only take about 30 minutes for the test to provide results. Therefore, assessing a score of 2 for Customer Validation, 2 for Market Size (US) , 2 for Competition and 3 for IP Position in Lab01, and earning a score of 2 for Technical Feasibility, 2 for Regulatory Pathway and 2 for Clinical Feasibility, our biomedical device meets, and excel, the standards for justifying the fundability of a medical device.