Difference between revisions of "Team:KUAS Korea/HP/Gold Integrated"

 
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<h4 id="exp"> Current Occult Blood Test </h4>
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<h4 id="exp"> Possible Practical Problems in Commercialization </h4>
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<p><font size=4>The conventional occult blood test has to go to the hospital directly and it takes a long time for the examination. According to our investigation, the test itself is not expensive. However, the whole examine process need a few expensive laboratory facilities hence it is difficult to perform the test in a poor medical environment. Also, we thought that patients would feel uncomfortable and shameful in the process of submitting their stools.</font></p>
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<img src="https://static.igem.org/mediawiki/2017/0/07/Occult_blood_test1.jpeg" width="330px" height="300px" allowfullscreen>  <img src="https://static.igem.org/mediawiki/2017/f/f1/Occult_blood_test2.jpeg" width="330px" height="300px" allowfullscreen>
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<p><font size=4>To find out the current circumstances and inconveniences of occult blood test that we might possibly improve through our project, we contacted to local hospital, Anam hospital of Korea University Medical Center. Fortunately, the chief of the hospital diagnostic laboratory gave us the opportunity to observe and discuss about the actual examination process with researhcers of clinical laboratory. We visited the microbiology lab on September 5th and saw the process of actual test. Researchers took out some of the stool from the sample collected from each patients, diluted it in the test tube, and mixed it with the reagent and put it in the machine. The actual test time is about 3 hours, but since it is preferred to examine many samples (approximately 50 at a time) at one time, it took a long time gathering sufficient amount of samples from patients visiting the hospital.</font></p>
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<img src="https://static.igem.org/mediawiki/2017/d/d5/Occult_blood_test3.jpeg">
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<img src="https://static.igem.org/mediawiki/2017/e/e8/Gold_biome.jpeg">
 
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<p><font size=4>In the Republic of Korea, the whole cost of the occult blood test is about $10, but our national health insurance service supports half. But in developing countries, $10 is quite expensive. The measuring machine is also very expensive. Therefore, reducing costs and time of occult blood tests is the key to our project.</font></p>
 
 
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<p><font size=4>In the current occult blood test, taking stool is inconvenient and offensive. In our survey of patient, ( )% of people do not want to do this project. (설문조사 내용 등등 나중에) Based on this, it would be very convenient for patients to be able to easily test by simply eating our probiotics.</font></p>
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<p><font size=4>The interview with Asia’s first stool bank, Gold biome influenced us in strain selection and factors to consider in the industrialization process. Our team met Suk Jin Kim of Suk Jin Kim laboratory institute and discussed the MSA, FMT(Fecal microbiota transplant) of the company and the product developing a process for our project. <strong>We tried to compensate our project by reflecting the feedback and make our design into a real product which can make people more convenient.</strong> Utilizing bacteria in the food/medicine industry needs to conform to exceeding regulations of KFDA, and the institute recommended us to select target strains among the 19 authorized bacteria. When we proposed our initial experiment plan that used Lactobacillus Casei, the director stated that the percentage of lactobacillus consisting human fetus is below 1% and would not be the most appropriate bacteria for fetus pigmentation. He recommended using Bacteroides or Prevotella, which are dominant species in human gut in order to produce enough amount of pigment for visualization. In addition, they told us that the number of micro bacteria permitted to be included in food products is below 10 million, so we should also consider a number of micro bacteria that is being taken in at a time. However, the researchers do agree to the fact that lactobacillus is the most commonly used bacteria in the food industry, and has the high possibility in application to various products.<strong>They advised that if we solved the problem of sufficient pigment production for visualization, it would be suitable for actual product making with Lactobacillus.</strong></font></p>
 
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<p><font size=4>Occult blood is a precursor symptom of various internal diseases. Early diagnosis is therefore crucial to preventing those diseases. Our probiotic system has the advantage that it can be easily diagnosed anywhere and anytime with low cost.</font></p>
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<p><font size=4><strong>Also, when we discussed the product description of our project, we got practical feedbacks that focused on fulfilling the government requirements and safety issues.</strong> Korean media and the society are showing negative response towards genetically engineered products, and the strict government regulations do not easily allow GMOs until they pass the examination process of KFDA. These obstacles will make it hard for the release of the probiotics using synthetic biology. Apart from product release in the market, our consultation of product design process was mainly divided into delivering form and number of micro bacteria needed per intake. Our team previously thought of capsules that are only activated in intestines by pH condition. The director responded that capsule was a great idea to deliver as much lactobacillus to the intestine and fetus, but in that case, we should target specific conditions of the intestine that is not available in other organs. Furthermore, during the digestion process, the product will pass the stomach of the PH2 condition, which will not leave the bacteria alive until they make it to stomach. The capsule will be an efficient protection gadget for lactobacillus. Furthermore, the number of bacteria that should be loaded for one product also needs to follow government regulations. The CFU that is needed to be in one product is above 100 thousand and below 10 million bacteria. The probiotic product of Gold Biome includes 45 million bacteria due to the special government patent they registered. Regarding the small number of bacteria remaining in the fetus, we should put as many micro bacteria as possible in the capsule. Not all bacteria we intake survive, so the upper boundary for a number of bacteria may not be enough to show a dramatic change in fetus color. This is another problem we should solve. Adding to this, a trivial feedback was also about pigment color. The color of a human fetus is more various than we could imagine, so the pigment color should be either fluorescence or color that cannot appear on the normal human fetus. </font></p>
 
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<h4 id="exp"> Current Stool Test </h4>
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<p><font size=4>Based on the feedback we received from the Gold Biome, we could think about practical problems that could occur when commercialized and resolution for them.</font></p>
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<p><font size=4>The fecal culture for infection is held at every public health center in Korea for 1.5 thousand won. This is one of the national medical insurance service offered from Korean Government and is needed for employment in the foodservice industry. </font></p>
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<p><font size=4>The process is as follows. First, you visit the public health center near your residence. After you write your personal information, they give you a cotton swab in a bottle. Then, you go to the restroom and collect your fetus component in your anal. If you submit the swab to the front desk, the clinical pathology center will analyze your stool and give permission your health document needed in employment. It takes about one to two weeks to receive your test results. </font></p>
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<p><font size=4>In the meantime, the analyzation of stool is held in the pathology center in public health center. The stool samples from the test participants are cultured in isolation on MacConkey and SS culture medium. After culturing them, if a suspicious colony is detected, the center subculture this colony on KIA culture medium separately. Final identification is done through using special API kit. The principle of API kit is inoculating and culturing bacterial suspension in test tubes that have specific dry materials such as TDA or JAMES. While it is being cultured, if a specific bacteria, for example, Salmonella Typhi, the color of the test tube changes by itself or by addition of secondary reagent, and shows the presence of specific bacteria. The visualized color can be recognized its differences in each bacteria. Eventually, the test results are delivered to the participants. The analyzation process is held in a fixed procedure and takes up 26% of the task of each public health center test center.</font></p>
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<h4 id="exp"> Consulting with Gut Microbiome Specialist </h4>
 
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<p><font size=4>The statistical data provided by Inha medical university medical center shows that these tests are the most efficient regarding all existing techniques in detecting waterborne diseases such as cholera or typhoid fever, which are dangerous infectious diseases. However, even though these tests are held at a cost, the government budget is used in this process is sufficient compared to the number of detected disease carriers. The total national budget used in health center is 100 million won including labor costs, and allocation per one typhoid carrier is 1.11 thousand won at a year (Inha Medical school disease control center, 2008). However, the number of carriers found are below 100 and are identified in a sporadic pattern. Not only the expense used from the country but also time consummation could be inconvenient for the users who want the results in a short time. If we also calculate the time usage of visiting the health care center, this becomes a huge consumption, as the result comes about a week after on average. By researching about this process specifically, we could observe the expense charged in stool test in a reasonable manner.</font></p>
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<p><font size=4>An interview with professor Kim Hui Nam, who majors the rumen microorganism was our first attempt to get advice regarding our project, POO-robiotics, and simultaneously an approach to see our project in academic perspective from outside, as one of our efforts to inspect our idea in three kinds of perspective- scholar, businessman, and patients.</font></p>
 
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<p><font size=4>While researching on cost analysis of current stool test, we thought that we could also analyze the cost efficiency of our own project ‘POO-robiotics’. If you follow our link down below, you could check our dry lab modeling on the expense compared with the previous stool tests.</font></p>
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<p><font size=4>Our major interest was whether our project has practicality, reliability, and feasibility. After we presented our project, professor Kim expressed his concern that the pigment method is not much feasible since it is hard for one to distinguish the color of the pigment expressed by microorganism and foods that a person ate if those two has a similar color. What he pointed out was that the problem is not about the expression itself but how to make a significant amount of expression enough to be detected by a naked human eye.</font></p>
 
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<h4 id="exp"> Legislative Improvements for Future Application </h4>
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<p><font size=4>Discussion with professor helped us to deduce three solutions. One was <strong>to consider the method for an uptake of ‘POO-robiotics’.</strong> We expected that If patients avoid certain foods that have the high opportunity of confusing, there would be much higher chance of an accurate detection. Another was to use another signaling method, which is the fluorescence method. Instead of expressing pigment, <strong>we decided to manipulate Lactobacillus to express fluorescence.</strong> Unlike pigments, fluorescence proteins can be <strong>clearly distinguished under UV conditions.</strong> In addition, the fact <strong>that fluorescent proteins do not require precursor</strong> is one of its strength. <strong>The last was to design a signal-amplification pathway.</strong> We thought of using microorganism’s quorum sensing molecule, which was beyond our capacity to prove results by experiments. So, instead of performing the actual experiment, we incorporated our concept into the modeling to compare the outcomes. </font></p>
 
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<p><font size=4>While we were working on a collaboration with other teams about legislations of GMM, we found out that current regulations are very limited for scientific progress. Moreover, throughout our visit to the public health center and hospital for an occult blood test, we checked how current tests are executed and their limitations.</font></p>
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<p><font size=4>We also asked about the intaking method of the Lactobacillus. Since <strong>our project’s major goal was to make easily consumable probiotics</strong>, using capsules were not acceptable for it has no difference with the conventional approach. <strong>What we have previously thought was to make it as dairy products, like yogurt.</strong> However, there was a general concern whether lactobacillus can safely reach the intestine, through stomach acids. Professor’s explanation was that, even though some of the probiotics die, rest of them would eventually reach the intestine and fully function as they designed. Besides, oral intake is what many of commercial probiotics has adopted.</font></p>
 
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<p><font size=4>We contacted one of the members of the Congress, Jeon, Hye-suk (전혜숙), who graduated from the college of pharmacy and has a master’s degree in medicine, health clinical pharmacology and made a visit. There we mainly discussed what kind of hurdles our product would have after it is released to the public. Our aim for visit was to demand improvement of associated laws and to further discuss how to make these ethical issues into the society. In order to enact or relieve a regulation, there must be the consensus of people in general. However, people barely give attention to synthetic and transformed microbes and thus it is even hard to publicize the issue. We concluded that we need to make efforts to communicate more with the public about GMO and further GMM and synthetic biology.</font></p>
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<p><font size=4>So, in the aspects of academia, we could solve the signal-expressing problems and devise the means of probiotic consumption. Our goal here was focused on the materialization of the idea, not considering things such as economic feasibility nor convenience.</font></p>
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<p><font size=4>Under Korean current GMM law, the usage of the GMMs is strictly regulated by the ‘GMO law’. Compared to the United States where most plant GMOs are considered equivalent to non-GMOs and do not require much further approval unless they have significantly different protein, Korea has to go through many regulations and tests. Each test requires more than 210 days which makes the approval way longer. In addition, compared to the United States and Japan, where there are no requirements for labeling products or only requirements for labeling products that contain modified gene more than 5% of its materials, in Korea, where the product with more than 1% of genetically modified material, such as DNA and proteins, must be labeled as GM food. If there is less than 1%, it is not necessarily required.</font></p>
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<h4 id="exp"> Visiting Microbiology Lab at Anam Hospital </h4>
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<p><font size=4>In Pursuance of relaxation and improvement of regulations on GMMS, we compared ours to different nations’ and discussed with the Congress member to seek compromises. However, in conclusion, it seems that it is not a quick-and-easy problem that we can solve right away and have to see it in long-term requiring supports from the public and congress members.</font></p>
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<p><font size=4>While we were working on a collaboration with other teams about legislations of GMM, we found out that current regulations are very limited for scientific progress. Moreover, throughout our visit to the public health center and hospital for an occult blood test, we checked how current tests are executed and their limitations.</font></p>
  
 
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Latest revision as of 07:05, 28 October 2017

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Integrated Practices




Possible Practical Problems in Commercialization



The interview with Asia’s first stool bank, Gold biome influenced us in strain selection and factors to consider in the industrialization process. Our team met Suk Jin Kim of Suk Jin Kim laboratory institute and discussed the MSA, FMT(Fecal microbiota transplant) of the company and the product developing a process for our project. We tried to compensate our project by reflecting the feedback and make our design into a real product which can make people more convenient. Utilizing bacteria in the food/medicine industry needs to conform to exceeding regulations of KFDA, and the institute recommended us to select target strains among the 19 authorized bacteria. When we proposed our initial experiment plan that used Lactobacillus Casei, the director stated that the percentage of lactobacillus consisting human fetus is below 1% and would not be the most appropriate bacteria for fetus pigmentation. He recommended using Bacteroides or Prevotella, which are dominant species in human gut in order to produce enough amount of pigment for visualization. In addition, they told us that the number of micro bacteria permitted to be included in food products is below 10 million, so we should also consider a number of micro bacteria that is being taken in at a time. However, the researchers do agree to the fact that lactobacillus is the most commonly used bacteria in the food industry, and has the high possibility in application to various products.They advised that if we solved the problem of sufficient pigment production for visualization, it would be suitable for actual product making with Lactobacillus.


Also, when we discussed the product description of our project, we got practical feedbacks that focused on fulfilling the government requirements and safety issues. Korean media and the society are showing negative response towards genetically engineered products, and the strict government regulations do not easily allow GMOs until they pass the examination process of KFDA. These obstacles will make it hard for the release of the probiotics using synthetic biology. Apart from product release in the market, our consultation of product design process was mainly divided into delivering form and number of micro bacteria needed per intake. Our team previously thought of capsules that are only activated in intestines by pH condition. The director responded that capsule was a great idea to deliver as much lactobacillus to the intestine and fetus, but in that case, we should target specific conditions of the intestine that is not available in other organs. Furthermore, during the digestion process, the product will pass the stomach of the PH2 condition, which will not leave the bacteria alive until they make it to stomach. The capsule will be an efficient protection gadget for lactobacillus. Furthermore, the number of bacteria that should be loaded for one product also needs to follow government regulations. The CFU that is needed to be in one product is above 100 thousand and below 10 million bacteria. The probiotic product of Gold Biome includes 45 million bacteria due to the special government patent they registered. Regarding the small number of bacteria remaining in the fetus, we should put as many micro bacteria as possible in the capsule. Not all bacteria we intake survive, so the upper boundary for a number of bacteria may not be enough to show a dramatic change in fetus color. This is another problem we should solve. Adding to this, a trivial feedback was also about pigment color. The color of a human fetus is more various than we could imagine, so the pigment color should be either fluorescence or color that cannot appear on the normal human fetus.


Based on the feedback we received from the Gold Biome, we could think about practical problems that could occur when commercialized and resolution for them.


Consulting with Gut Microbiome Specialist


An interview with professor Kim Hui Nam, who majors the rumen microorganism was our first attempt to get advice regarding our project, POO-robiotics, and simultaneously an approach to see our project in academic perspective from outside, as one of our efforts to inspect our idea in three kinds of perspective- scholar, businessman, and patients.


Our major interest was whether our project has practicality, reliability, and feasibility. After we presented our project, professor Kim expressed his concern that the pigment method is not much feasible since it is hard for one to distinguish the color of the pigment expressed by microorganism and foods that a person ate if those two has a similar color. What he pointed out was that the problem is not about the expression itself but how to make a significant amount of expression enough to be detected by a naked human eye.


Discussion with professor helped us to deduce three solutions. One was to consider the method for an uptake of ‘POO-robiotics’. We expected that If patients avoid certain foods that have the high opportunity of confusing, there would be much higher chance of an accurate detection. Another was to use another signaling method, which is the fluorescence method. Instead of expressing pigment, we decided to manipulate Lactobacillus to express fluorescence. Unlike pigments, fluorescence proteins can be clearly distinguished under UV conditions. In addition, the fact that fluorescent proteins do not require precursor is one of its strength. The last was to design a signal-amplification pathway. We thought of using microorganism’s quorum sensing molecule, which was beyond our capacity to prove results by experiments. So, instead of performing the actual experiment, we incorporated our concept into the modeling to compare the outcomes.


We also asked about the intaking method of the Lactobacillus. Since our project’s major goal was to make easily consumable probiotics, using capsules were not acceptable for it has no difference with the conventional approach. What we have previously thought was to make it as dairy products, like yogurt. However, there was a general concern whether lactobacillus can safely reach the intestine, through stomach acids. Professor’s explanation was that, even though some of the probiotics die, rest of them would eventually reach the intestine and fully function as they designed. Besides, oral intake is what many of commercial probiotics has adopted.


So, in the aspects of academia, we could solve the signal-expressing problems and devise the means of probiotic consumption. Our goal here was focused on the materialization of the idea, not considering things such as economic feasibility nor convenience.

Visiting Microbiology Lab at Anam Hospital


While we were working on a collaboration with other teams about legislations of GMM, we found out that current regulations are very limited for scientific progress. Moreover, throughout our visit to the public health center and hospital for an occult blood test, we checked how current tests are executed and their limitations.