Difference between revisions of "Team:CCU Taiwan/Implementation"

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                     <p><b>Inexpensive</b><br><br>Peptides are easier to produce than antibodies, so the cost will be lower.</p><br>
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                     <p><b>Inexpensive</b><br><br>Peptides are easier to produce than antibodies, so the cost will be lower.</p>
<p><b>The table below shows the differences between producing peptides and antibodies, and why peptides cost lower.
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<p>The table below shows the differences between producing peptides and antibodies, and why peptides cost lower.
 
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Revision as of 18:46, 21 October 2020

Implementation

Overview

We hope to manufacture a dengue virus detection kit which is convenient, fast, and effective. We expect that by detecting the dengue virus precisely, medical care and epidemic control of dengue could be undertaken at early stage, which could prevent dengue from developing into a severe and life-threatening situation.


Target audience

  1. Proposed end users: Suspected dengue fever patients:

  2. Patients present symptoms like fever, muscle and joint pain, and skin rash.


    According to statistical data provided by Taiwan Centers for Disease Control (CDC), from 2011 to 2019, the number of tests conducted for dengue diagnosis fell between 2,700 and 9,300. These numbers show the basic need for our detection kit. Based on the outbreaks in 2014 and 2015, the need for detection kits could reach 70,000 during a dengue outbreak.


    By promotion of our product along with the spread of epidemics due to global warming, the demand for our product will increase continuously in the future.


  3. Stakeholders:
    • Taiwan Centers for Disease Control (CDC):

      Airports, harbors


    • Imported cases are the main contributors to dengue epidemics in Taiwan. Patients who have been to a dengue affected foreign country and reported being bitten by mosquitoes may bring the virus back to Taiwan, which may result in a local outbreak thorough the local transmission.


      The number of imported dengue cases in Taiwan is growing every year. In 2018, the total number of indigenous cases was 183, while imported cases numbered 350. In 2019, the imported cases increased to 350 while there were only 100 indigenous cases . The number of imported cases greatly surpasses the number of local cases and has become the main reason for Taiwan dengue outbreaks.


      Thus, fever screening stations are set up by CDC at airports and harbors. Everyone going through immigration will undergo infrared temperature detection. Anyone entering Taiwan who shows an abnormal temperature has to take a dengue rapid detection immediately. In Taiwan, about 70% of the cases of imported notifiable infectious diseases were dengue fever, and 40-50% of imported dengue fever cases were effectively detected by the fever screening.


    • The Department of Health of each county:

      Hospitals, clinics and health care centers


    • Based on the Regulations for Medical Devices set by the Ministry of Health and Welfare, a dengue virus detection kit is classified as a Class II medical device. It should be used under the supervision of professional medical workers. Thus, our product will be available to hospitals, clinics, and health care centers. The public can go to any medical institution and use our product for dengue diagnosis under the assistance of medical workers.


      Currently nearly 2,000 medical institutions provide dengue fever rapid detection service. Those detection kits are controlled and distributed by the Department of Health of each county.


    • The Environmental Protection Bureau of each county

    • Besides individual diagnostics, our product could also be used in vector surveillance in the environment. We could determine the vector infection rate in the environment by collecting and testing mosquitoes. Currently, nearly 3,350 residential areas conduct dengue vector surveillance every month under the auspices of the Environmental Protection Bureau. Thus, our product could be used to test the infection rate of vector at the same time.


Supply chain


Goals

Short-term:

  1. Develop a detection kit focusing on dengue virus serotype 2.
  2. Sell the product to the relevant institutions.

Mid-term:

  1. Optimize our product.
  2. Develop a detection kit for all 4 serotypes of dengue virus. Establish the product in the Taiwan market.

Long-term:

  1. Look for an authorized distributor or authorized manufacturer to expand the foreign market and sell our product overseas.
  2. Focus on selling our product to developing countries and remote areas, where it has a comparative advantage.

How to do


Value

Innovative

Using synthetic biology, we produce peptides utilized in a detection tool. The peptides have high flexibility. The peptides can distinguish different flaviviruses and serotypes of dengue virus, by changing their amino acid sequences. They can also be adapted to the mutations of the dengue virus.


Convenient

Our product can be used in the developing countries or remote areas, as no laboratory or instruments are needed for detection. The peptides have high stability, which makes them easier to be stored and transported to other countries.


Rapid

Our detection kit takes only 15 to 30 minutes to get results, which can help the appropriate units to take medical or preventive actions as soon as possible.


Domestic

Taiwan is currently using the detection kits imported from overseas. A domestic product could prompt Taiwan to build up its own biomedical industry chain, which can react immediately when outbreaks occur without relying on the foreign aid. This would help Taiwan to be more proactive in epidemic control.


Inexpensive

Peptides are easier to produce than antibodies, so the cost will be lower.

The table below shows the differences between producing peptides and antibodies, and why peptides cost lower.


Producing peptides using E. coli Generating antibodies using B cells
Culture medium for E. coli cultivation is cheaper and is able to cultivate multiple varieties of E. coli. Culture medium for B cells is more expensive.
B cells cannot be produced on a large scale and may be contaminated.
Induction of peptides can be done on a large scale through IPTG as lac operons appear in E. coli. Generation efficiency of antibodies is low, as antibodies are not main proteins produced by a B cell. There is no way to induce B cells to massively produce antibodies.
Peptides can be purified efficiently as there are specific tags on the peptides. Purification of antibodies requires specific proteins (i.e. G protein), which also require time for production and purification.
B cells have to be immortal before generating antibodies.

Users' guide

Our product will be sold in boxes. There will be 10 detection kits and 10 lancets, separately packed in one box, with a 5 ml bottle of MES buffer. MES buffer is used to stabilize the pH of the blood sample and improve the lateral flow.


One detection kit, one lancet and one drop of MES buffer are used for one diagnosis.



  • Use under the supervision of medical workers only. Wear gloves when using and wash hands after using.
  • One bottle of MES buffer is sufficient for 10 detection kits. Other equipment should be properly disposed of after a single use.
  • Store in a cool place away from direct sunlight.
  • The validity of product is one year.

A detection kit for use with mosquitos to test vector infection rate is sold in boxes without a lancet. Use one detection kit and MES buffer for each diagnosis.



  • One bottle of MES buffer is sufficient for 10 detection kits. Other equipment should be properly disposed of after a single use.
  • Store in a cool place away from direct sunlight.
  • The validity of product is one year.


References

Dengue Fever Nationwide, Indigenous and Imported, Week1/2019-Week43/200〔Date of Onset 2018/12/30/2020/10/24〕, Taiwan National Infectious Disease Statistics System. https://nidss.cdc.gov.tw/en/nndss/disease?id=061
Shie-Liang Hsieh, Yu-Chih Lo, Pin Ling, Shu-Ying Wang, Chia-Yi Yu, Guey-Chuen Perng, …Chih-Peng Chang (2016). Dengue Fever in Taiwan: The New Perspectives from Epidemiology, Clinical to Fundamental Science, Ministry of Science and Technology. http://boe.tn.edu.tw/boe/wSite/public/Attachment/f1466038079289.pdf
Disease Surveillance Express, Taiwan Center of Disease Control (TCDC) (2009-2020). https://www.cdc.gov.tw/En/Category/List/Nim1Frm1C1ELxEhJ_hdJBg
Hospitals With Dengue NS1 Rapid Test, Taiwan Center of Disease Control (TCDC) (2020). https://data.cdc.gov.tw/en/dataset/dengue-ns1
Dengue Mosquito Investigation in Latest 12 months, Taiwan Center of Disease Control (TCDC) (2020). https://data.cdc.gov.tw/en/dataset/dengue-mosquito-investigation-latest-12mM
The Serum Reagent of dengue virus Guidance (2017). http://regulation.cde.org.tw/data/downloadfile.php?sid=1269