BME100 f2017:Group14 W1030 L2

BME 100 Fall 2017	Home People Lab Write-Up 1 | Lab Write-Up 2 | Lab Write-Up 3 Lab Write-Up 4 | Lab Write-Up 5 | Lab Write-Up 6 Course Logistics For Instructors Photos Wiki Editing Help
OUR TEAM Name: Lydia Gabric Name: Anshul Krishnan Name: Christopher Ward Name: Sara Bacon Name: Charmayne Seaton LAB 2 WRITE-UP Device Image and Description Technical and Clinical Feasibility Technical Feasibility Some of the possible challenges we will face include the technological aspects that test the urine. The chemical reaction that the Gonorrhea and Chlamydia test is based off of uses a swab instead of urine. Our group instead wants to be able to detect the bacteria in the urine rather than a swab. The test has to have a high accuracy rating. Another challenge is making the product easy and straightforward to operate. The package also must include easy to read directions that any individual could understand without difficulty. The test needs to have proper packaging to prevent spillage and contamination. It is possible during shipping and handling that the buffers and tests could be damaged. The individual who is being tested will need to mix buffers and apply them to the test. It is possible for someone to accidently mix incorrect buffers or incorrectly apply the solution to the testing stick. Clinical Feasibility Our product is designed to have accurate testing in the privacy and comfort of the individual's own home. Most urine STD testing occurs in a laboratory with the process called ligase chain reaction. Our testing product is trying to use immunoassay to detect the bacteria. Our product deals with bacteria cultures and one needs to take precautions when completing the test. Also, if the test has a false negative result it would directly affect the consumer. There are not a lot of at home testing products that are in clinical trials, but there are trials on at home STD testing effects on the individual lives and how the home test results compare to clinical testing. There is one study based off of Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing (SOVS-CTG). This tested the results of the SOVS vs. when the sample is collected in a clinical setting where the individual was there for 24 hours. This study was conducted from April 2013 to June 2016. Another study examined the individuals feelings towards at home testing. This study was of random Men in the St. Louis area that completed an at home or clinical STD test. The at home samples were sent through the mail, while the clinical STD test occurred at a local clinic. This was a 12 week study. Market Analysis Value Creation Manufacturing Cost Sales Price Market Size Fundability Discussion