Team:Strasbourg/Human Practices

iGEM

Our Strategy

As we are working on the development of a detection kit for allergens we decided to investigate the impact that our kit would have on the daily life of people.
To this end, we conducted various interviews to obtain the opinion of various experts in the field. We questioned the impact of allergies in France, how they are managed and the usefulness of our kit. Therefore, we met with several health professionals (general practitioners, nurses, pharmacists, dieticians) and health control professionals working in the private (food inspectors) and public (the departmental directorate for population protection) sectors. To complement the experts' opinion, we interviewed people suffering from food allergies to gather their stories and see how they handle the problem in their daily lives. In addition, we asked them for their opinion on our project because they are the people who are directly concerned with the use of our detection kit.

We also designed 3 surveys : The first one "Allergies in the French population" aims to study the proportion of people affected by food allergies in France as well as the proportion of people who have already had an allergic reaction during meals in different situations (home vs. outside). We were also curious about the interest of the French population in our kit. We asked the respondents about their knowledge of allergies and their relationship with allergists in order to investigate the usefulness of educational campaigns on this subject. Following this we decided to set up a "Did you know" campaign on our social networks.
The second one "How iGEM teams experience the problems associated with food allergies in their country" helps us to have an international vision of the problem that food allergies can represent in different countries through the eyes of other iGEM teams. It is also useful for us to measure the impact that our detection kit could have in these countries.
The last one "Allergies in children in the French population" was done to get an idea of the knowledge of children aged 7 to 11 about allergens and the impact of allergies on their daily lives. This survey then gave us the idea of creating a small comic book and a storybook for children to raise their awareness.

The system of our kit is based on a triple hybrid system implemented in E. coli. The specificity for the different molecules will be provided thanks to an aptazyme which can be interchanged. In order to develop the system in the best possible way, we met with specialists in the field of aptazymes and aptamers. In particular, we met Jörg S. Hartig, Head of the Chemistry and Synthetic Biology of Nucleic Acids Team at Konstanz University in Germany. His expertise was crucial to us for the choice of the aptazymes to use to achieve our proof of concept of the system. He advised us to use two aptazymes that he developed himself and has been ready to give us protocol advice. We also participated in the RNA club symposium in Bordeaux. This event welcomes many scientists from all over the world to discuss on RNAs. This year the RNA Club was organized jointly with the Aptamers in Bordeaux. We, therefore, presented a scientific poster with our system and preliminary results to get expert feedback on our project.

Experts' View

As a part of our Integrated Human Practices, we really wanted to think our project in relation with today's society and refine our work. In order to see if our project could have a real impact, we interviewed people with several backgrounds.

Meeting with apatazymes and aptamers experts

We created a new detection system based on aptazyme use. After the selection of our project idea, we had the chance to be supported by Professeur Ryckelynck, one of our PIs, whose research subject is closely linked to the RNA world. Professor Ryckelynck invited the aptazyme expert Professeur Jörg Hartig from the University of Konstanz (Germany) to meet our team and lead a seminar on “Engineering ligand-dependent ribozymes as artificial riboswitches”.

Our team met Pr. Hartig 24 of May for an interview and participated in his seminar. Thank to this meeting we discovered some important points about aptazymes selection and construction as well as the particularities of their use in a bacterial model.
Pr. Hartig helped us to choose the sequences for our aptazymes, as he had previously published those sequences.
Additionally, it gave us the chance to get very useful advice on in vitro transcription, on the treatment of our results and a list of publications which were helpful to establish our protocols. Pr. Hartig accepted to be reached by mail in case of trouble with our aptazyme experiments. This interview was an essential event for the development of our scientific part. After this meeting, we participated in a seminar to discover the basic modalities of aptazyme engineering.


On the photo (left to right): Pr. Jorg Hartig, Team Leader Kateryna Len, Lab responsible Claire Husser, Team leader Yasmine Amrani, iGEM PI Pr. Michael Ryckelynck







RNA club symposium



In June, our team leader Yasmine Amrani participated in the 11TH RNA club symposium that took place in Bordeaux.
The Bordeaux RNA Club Symposium brings together French, European and international researchers for two days of scientific talks and discussions in summer. This year, the Bordeaux RNA club symposium will be organized jointly with Aptamers in Bordeaux.
We had the opportunity to present our project advancement to guest scientists during the poster session. We had a lot of positives feedbacks and we obtained many good advice for our future investigations.



Allergics person opinions

Soufiane, 24 years old: Always in his mind

"I can't take the risk and eat anywhere, especially in fast food! I have to be careful with everything I consume to not aggravate it.

"When you're allergic, and you've like a 50% charged phone, your end could be quick if you don't take precautions."

"One time, I went out to eat, I chose a meal and asked the waiter if it contained any of the foods I am allergic to. The waiter told me no. Immediately after starting to eat, I had an asthma attack. Later I discovered that the meal contained a large quantity of eggs."

"When it comes to health, there's no place for adventure."

Juliette, 20 years: Smell the peanuts

"I have developed a real aversion to the smell of peanuts so if there are any in the dishes I don't eat them. I can [really] smell it except for peanut oil - then, unfortunately, I can't smell it. Anyway, I ask as much as possible in order to avoid an allergic reaction, I don't want to take any risks and finish at the hospital."

Marine, 20 years: Suprise Allergy!

"I had three small allergic reactions while eating different mixed dishes (kebab, salad) and each contained raw carrot, so to be sure I bit into an uncooked raw carrot (to rule out the possibility of a nut sauce, or that kind of thing), and I had one more reaction."

Lorraine, 23 years old: Don't talk to me if you just ate M&M's!

"I am allergic to peanuts and even the smell makes me feel bad. When my friends eat M&M's or Curlys I usually go talk to someone else, otherwise I have a headache and asthma!"

"My first memory of my allergy to peanuts is quite old: I was 8 and I was eating chicken with a peanut sauce in a restaurant. I told my parents that I didn't like it and that it made me sick but they did not believe me. Luckily they had some medicines to treat it when they understood I was not pretending."

Florent, 25 years old: No more desensitization for me...

"I tried to get decensitized for my allergies but I could not finish because I had a severe allergic reaction to the sublingual solution. It was moreover difficult to purchase the treatment as it was not available in pharmacies."

AptaTest, a powerful kit for children and teenagers

The impact of AptaTest on children, as seen by nurses:

We had the opportunity to interview two nurses, Solène Carl and Sarah Vallade. Their jobs consist in taking care of patients and managing emergencies. For this reason, we wanted to hear their opinion on our allergen detection kit and the targeted population.
Sarah and Solène had a good feedback on our project! They thought that it is an excellent idea that might relieve many people in their daily lives. They suggested to target children and teens under 18 as they have more difficulties than adults to manage their allergies.

Their opinions in a few words:

"You should especially target children or teenagers! How many parents are worried to let their child, with known allergies, goes to a birthday party or eat at school? So many! It might also benefit older children and teenagers, as it is burdensome to always have to watch its alimentation closely, especially when allergens are badly indicated. They tend to forget about it and end up having allergic reactions. A portable detection kit could make their lives much easier! Adults are more responsible, they worry more about their wellness than young people!"

Their impact on our project?

We agreed that it might be interesting to target young people. To evaluate the market among young people, we created a survey conducted in a summer camp to assess the proportion of allergic children, their knowledge of allergies and the best way to raise their awareness. It showed that all children were poorly informed about the risks of allergies and allergic reaction itself even those who are allergic! Therefore, we decided to create educational supports in the form of a comic book which explains the concept of allergy and a storybook to promote the right course of action in case of an allergic reaction. We distributed these supports in a primary school and got a feedback from the children.


The impact of AptaTest on children, as seen by school teacher:

As the nurses suggest us to target children, we did a survey on 129 children in a summer camp as well as an interview of a first grades’ teacher, Laura. We wanted to get her opinion on our detection kit and our public engagement strategy. Her feedback was really instructive! Who would have a better spot than a teacher to help us understand allergic children’s life when they are not home?

At school, procedures exists to handle allergic reactions from children. Firstly, the school director inform each teacher personally of special situations they might have to handle during the years as well as associated procedures specific to each child. Secondly, a mandatory document called PAI (Projet Alimentaire Individualisé, which stand for Individualized Alimentary Project) is linked to each student and mention the allergies, the potential treatments and the procedures needed in case of an allergic reaction (see Figure below). Lastly, the parents and emergencies are called if it is necessary.

We also learned about the incredible alertness of all the teaching staff: they are indeed responsible for children’s safety as soon as they arrive at school. In order to be as efficient as possible, Laura’s school created a wall in the teachers’ room with the children’s picture, their allergies, the associated procedures and the first aid to help all teacher to react quickly (Figure below). Each teacher is responsible for his own class but the medicines are always visible in a box in the class to allow a fast and efficient intervention from everyone (Figure below). 25 children on the 80 in her school have an allergy, which represents about 30% of the total headcount!

Her opinion in a few words:

“The kit could be very useful, especially for school trip or for snacks. It would help us to detect allergens in food where we do not expect to find them! This should not lead to a decrease of our vigilance because we are responsible for them and I will maybe not have time to use it as I have to handle many children at the same time, or I will maybe not think about it at the beginning as it is not an automatism.”

In her class, a student is allergic to peanuts:

“The poor child cannot eat anything outside… [This test] would make his life easier. It would not have to tell himself “I can’t eat anything”. If it is easy to use it, it is nice! If we learn how to use it and it becomes an automatism, it would be awesome for him!”

Her impact on our project?

This interview confirmed that AptaTest can be useful for the children and the teacher, as long as the use of the AptaTest is easy and becomes an automatism. While developing our kit, we took into account that it should be easy-to-use so it seems to us that its utilization is suitable for children! It would be like a toy that would make their life easier. Moreover, when we asked about the allergens’ display in the canteen, Laura told us that nothing was indicated for the children or for the teachers. We are thus optimistic in the idea that AptaTest is a real way to sustainably help allergic people and their relatives.

Meet a wellness professional

Finally, we had the chance to interview Thierry Claudel, a dietician-nutritionist. It helped us to better understand his job and its contribution to the well-being of people. A dietician is a health professional who works with patients as well as organizations (local authorities, company catering, canteens). When he is working with patients in his practice, the support he can provide depends largely on the willingness of his patients. He helps them to create menus, suggest food and recipe ideas, etc.

"My role is part of a voluntary process coming from the patient. They come to me to improve their eating habits. I try to teach them to be independent by guiding and advising them to help them to have a balanced diet. I listen to their expectations and needs, I determine by discussing with them what diet is the best for them and I try avoiding cognitive restriction, i.e. forcing themselves to avoid the food they love. This can have a very negative impact on a person! Wellbeing is linked to food."

He can be a precious help for allergic people.


"The care is quite limited. When people are allergic, they know it and generally avoid automatically the foods likely to contain it. Our help is quite limited insofar as they do not need me for that. However, especially in cases of cross-allergies, I help them find an equivalent to get the nutritional intake they lack with their allergies. For example, people who are allergic to nuts may have a lack of omega 3 because nuts are rich in omega 3. I help them to find other sources of omega 3 to compensate and have the necessary intake for their diet."

In case of eating disorders or small food intolerances, he advises to integrate in small amounts the foods causing intolerance. He gave us many examples of intolerance, such as irritable bowel syndrome: people with this syndrome have stomach aches, severe discomfort, impetuousness etc. because of vegetables. The impact can be more or less significant on the person and their social lives. And it can have severe impacts on their lives or well-being, but ''it will depend on the people, the level of discomfort and accommodation specific to each'' he adds.

For him, our AptaTest might have an interest in cooking classes.


"I don't have an interest for this kind of kit, but I have many colleagues who do cooking workshops with their patients and this could be useful to avoid allergies due to mislabelling of food used in the workshops."

He also gave us his opinion on the use of the AptaTest for allergic or intolerant people:

"Allergic people forbid themselves many things and often for no reason. They are so afraid of triggering their allergies and there is so little information sometimes in restaurants and on labelling that they decide to not take any risks. It would be very interesting for them to have a portable detection system because they allow themselves less things than they could. It would really be great, if it's effective and if in the long term you develop a dose-response system it's even better! If it is not very expensive and easily usable you have every chance to market it. This would make life easier for people with allergies! Keep going!"

He advised us to look at casein, a protein in milk, or gluten as everyone is sensitive to it with various degrees. He told us to focus our interest first on the list of major food allergens in an attempt to target have a broader target.

His impact on our project?

Meeting a wellness professional was very useful to understand how The AptaTest could be an excellent tool to sustainably improve allergic people’s lives. It confirmed the potential usefulness of our project for different people. Thanks to his knowledge of the catering environnement, he suggested to also consider professionals (cooks, people in quality control, etc.) as potential users of our test. We therefore interviewed professionals experts (see below). Moreover, he helped us to judiciously choose the allergens we should detect and thus to focus first on the modelization of our aptazyme.


AptaTest, a role in Food Quality Control?

We had the opportunity to interview Lison Benoist, who works at Merieux NutriSciences, a private company that analyze products for food suppliers in order to check if they are consistent with food and hygiene standards. She have to audit and to form several chains of restaurant, hotels, and stores but also some institutions such as childcare, centers for handicapped persons and prisons.
We asked her about allergen legislation and control related to allergens. She explained us that "all restaurants and other places proposing food have to clearly indicate allergens that are present into their menus, hence I check whether it’s done or not.”
When we inquired about the technical controls and if food was analysed to check the presence of allergens, we were surprised to learn that no samples are taken for analysis! In these conditions, how can they guarantee the absence of allergens without the proper controls?

To answer this question, we looked for a government agency involved in food controls. We contacted the Departemental Direction of Population Protection (DDPP) and had the opportunity to discuss with Mrs. Wagner Martine, Expert Inspector of Competition, Consumer Affairs and Fraud Control. As it is an institution which is not well-known by the general public, we learned valuable information during this meeting.
The mission of the DDPP is to control food products placed on the market and guarantee their safety (from industrial products to catering products). It relies on French and European Reglementations and especially the Regulation 1169/2011, best known as INCO regulation. This regulation exists since 1969 in France and was adopted by the European Union since 2011 and in USA came into force on January 1, 2006 (FALCPA 2004, Act 108-282, Title II : Food Allergen Labelling and Consumer Protection Act). It regulates the labeling of foodstuffs: they have to be readable and should mention the origin of the product, the allergens present and those which might have been in contact with the product and the nano-ingredients present. Its main goal is to ensure that consumers have all the information they might need. It is legally requested since 2016.
The DDPP mainly control the presence of allergens as well as the presence of lactose and gluten. In the past few years, "gluten-free" products have been increasingly controlled because of the increase in number of intolerant people.

Their opinion on AptaTest:

Your kit could be interesting for us and useful! As far as I know there are no such things as a sensing tool we could use. Moreover, it could be really interesting to verify if there are no allergens that are not reported on the menu”

-Lison Benoist


This detection kit is a very good idea but people concerned by allergy problems may not buy it if it is not free. Nevertheless, it could be widely used by people who have very significant allergic reactions and who need to be sure that allergens are not present in their diet. If this kit could detect gluten, it would be much more successful.’’

-Mrs Wagner Martine.

Their impact on our project?

The input from Lisbon Benoist made us realized that other markets than patients exists. Regulatory authorities and audit firm might also benefit from it.
Mrs Wagner Martine. brought a very interesting point with gluten: people with coeliac disease and intolerant people might really struggle to find adapted meals and would certainly be interested by AptaTest


AptaTest: on the road for commercialization?

As pharmacist are often the first contact of patients with the medical world, it made sense for us to get their opinion on the potential use of AptaTest by patients and the interest of our project for them. We thus interviewed Catherine Kappel, a pharmacist from Strasbourg.


"From my perspective and experiences, I find your idea interesting. This would allow to detect traces of allergenic substances which may not been specified on labeling in supermarkets or in restaurants."

She also gave us a valuable insight on allergy medications, patients' symptoms etc. Above all, it allowed us to investigate the possibility of releasing the AptaTest on the market.

"There is a whole process for marketing a medical product, starting with its design and validation. This part is highly time-consuming yet crucial. Then, you have to contact the competent public authorities and finally launch a marketing campaign in pharmacies. The advantage of a distribution targeting pharmacies is that it allows patients to benefit from the advice of pharmacists and to have a follow-up. On the other hand, the French social security system would probably not reimburse your detection kit because it does not directly improve the patients' health [...] but allergic people will be willing to pay!"

Her impact on our project?

After this interesting interview, we decided to deepen our knowledge on the marketing of medical and pharmaceutical products, in order to determine the time needed to launch our test if a startup based on it was created.

Experts' view conclusion

All these experts helped us all along our project and allowed us through their interview to evolve our vision of the AptaTest. They motivated us and confirmed the usefulness of our project. Their opinions helped us to think about the impact of our project on the world and to include real world data in its conception.



French and Global Surveys

Allergies and their perception in the French population

Context

This survey was designed by our team in order to study the proportion of people affected by food allergies in France. As our project is mainly focused on people with food allergies, we also looked at the proportion of people who have a known food allergy and who already had an allergic reaction during meals in different situations (home vs. outside). We were also curious about the interest of the French population in our kit. In the second part of this survey, we investigated the knowledge that the French has about allergies. We have widely distributed our survey on social networks, which has allowed us to collect 551 responses. This number of participants remains low compared to the 67 million people living in France. However, this panel represents a significant proportion of people living in France that we were able to reach through our iGEM project.

The survey was mainly answered by young people between 17 and 27 years old, probably due to our method of sharing via social networks. Our analysis, therefore, relates more to this age group. However, we also received responses from older and younger people.

The majority of the respondents come from the Grand Est region. However, we were globally successful in getting answers outside our region. Thus we were able to reach people from all metropolitan regions (except Corsica). This allows us to obtain a global opinion at the national level despite the fact that we have had little impact on the Centre-Val de Loire and Bourgogne regions and not at all on the French overseas departments and territories.

Proportion of people affected by allergies

Among the 551 people who responded to the survey, 384 persons (70%) suffers from allergies. This is much higher than the 30% announced by Inserm, which may also indicate that our survey has particularly reached allergic people. These are the people we would like to help with the development of our kit. Mostly those affected by a food allergy problem.


We also wanted to know when during their lives these 384 allergic people were diagnosed.

Most of these people (46%) were diagnosed during childhood but still 20% of people were diagnosed in adulthood. Allergy is a disorder of the immune system and the occurrence of an allergy is multifactorial (genetic field, environment, pollution...). An allergy can therefore be developed at any age but mostly during childhood. This result is therefore not surprising.



Symptoms of the reported allergies

    We have classified allergy symptoms into different categories:
  • Dermatitis
  • Digestive
  • Eyepiece
  • Respiratory
  • Others

Among the 384 allergic people who responded to the surveys, 233 (60%) suffer from respiratory symptoms (rhinitis, asthma, sneezing, runny nose, etc.). 198 (52%) suffer from dermatitis (red patches, itching, rash, angioedema) and 134 (35%) have eye symptoms (red eyes, runny eyes). Finally, 19 (5%) have digestive symptoms (vomiting, diarrhea). Some people also have other symptoms : kidney, articulations and ears problems.


To get an idea of the impact of allergies and related symptoms, we asked people with allergies to indicate on a scale of 1 to 5 how much the symptoms bother them in their daily lives. 1: very little disturbing 5: very disturbing.

Thus we have seen that 7% of people with allergies are extremely disturbed by their symptoms in their daily lives and that only 20% are not disturbed. Most of the allergic people interviewed are moderately bothered by their symptoms.



Treatments

As the symptoms associated with allergies are generally quite distressing, we wanted to know the proportion of allergic people who take treatments to relieve them.

Among the 384 allergic people who responded to the survey, we looked at the proportion of them who were monitored and treated for their allergies. We have found that only 46% of them were taking a treatment, which may include medication (antihistamines) or desensitization.


We also wanted to know what most people are allergic to.

Among these 384 allergic people who responded to the survey, the majority suffer from allergies to pollen, mites and pets. Nevertheless, among them 108 persons (27.9%) are affected by a food allergy.

The final objective of our project is the detection of food allergens in order to protect allergic people from a dangerous reaction related to the ingestion of incorrectly indicated allergens. We were therefore interested in the proportion of people with a diagnosed food allergy who still had an allergic reaction during a meal.

We first wanted to know if these people had ever had an allergic reaction when they were cooking for themselves.

Of the 103 people with food allergies who responded to this question, 29 (28%) have already had an allergic reaction while cooking for themselves.




We also looked at the proportion of these allergic people who have already had an allergic reaction following a meal taken outside.

Thus we have noticed that the proportion of people suffering from food allergy and who had an allergic reaction following a meal taken outside is much bigger with 75% of positive answers.




We wanted to know where these reactions have taken place.

Most of these allergic reactions occurred during meals in restaurants or at a dinner invitation (by friends, family, colleagues...).

We then wanted to get the opinions of people on the quality of allergen labelling on food products in France.

Among the 551 survey respondents, only 55% of them found that allergens are well indicated on products.




We also looked at the quality of allergen labelling in restaurants.

Interestingly, only 18% of the 551 respondents found that allergens are well indicated in restaurants. This information supports our belief that a portable kit for rapid allergen detection kit for people with food allergies would be useful.



In order to have a broader vision of the problems caused by allergies, we wanted to know the percentage of people who have someone with an allergy in their relatives. Indeed, when we are in contact with an allergic person, we must adapt our habits and especially for people suffering from food allergies, adapt meals.

Among the 551 respondents, 536 (97%) know at least one allergic person. Thus, the majority of the population studied is directly or indirectly affected by allergies. We have thus realized the omnipresence of this problem in daily life.




We wanted to know what allergies most of these people suffer from.

Most of the people who responded to the survey are in contact with people who are allergic to pollen and pets. 222 persons (42%) are in contact with people with a food allergy. It can also be noted that the allergies reported in the family circle of the respondents follow the same pattern as before.

Opinion on our detection kit

We wanted to get the opinion of people on the usefulness of a kit for the rapid detection of food allergens in France.

Among the 551 respondents, 387 people (70%) would be interested in a kit for the rapid detection of food allergens. These figures comfort us in the usefulness of our project.




A second part of our survey focuses on knowledge and awareness of the public about allergies.

Links with the field of biology/health

First, we asked whether the survey respondents work in the field of biology/health. Indeed, these people are more likely to be aware of the issue and the risks associated with allergies.

Overall, among the respondents, 265 (48%) work or study in the field of biology/health The fact that our project has mainly reached people in this field is interesting.





Allergists

The allergist is the reference specialist to help people with allergies. He establishes the diagnosis by carrying out tests (Patch test /prick test, blood test, skin test) and offers adapted treatments.

We therefore wanted to know the proportion of people who had already consulted an allergist among the 551 respondents to the survey.

Among the 551 people who responded to the survey, 237 have already been to an allergist. (43%). However, most people (57%) have never consulted this doctor. Moreover, most of the respondents to the survey suffer from allergies (384). These data therefore indicate that some allergic people have never consulted this specialist.


We also wanted to know the main reason for the consultation with the allergist.

Of the 237 people who have already consulted an allergist, most have gone for a medical examination (72,3%) or for medical treatment (49,8%) such as desensitization for example . Some people also go there to receive information (27.8%) or simply to accompany someone close to them (21.9%).

We wanted to have an overview of people's knowledge about allergies. So we first asked them if they think that the number of people with allergies is increasing. This is indeed the case and in particular, the WHO estimates that by 2050, half of the world's population will be allergic to something.

Overall, the majority of respondents are aware of the increasing prevalence of allergies. However, 44 people (8% of the panel) believe that allergy is not a growing problem.




Survey respondents were also asked if they were aware of the biological principle of allergic reaction.

The majority of the respondents (53%) are aware of the biological principle of an allergy. However it was noted that our panel works mainly in the field of biology/health. But nevertheless, 261 people (47% of respondents), are not aware about how the allergic reaction works.


We then asked them if they would like to know more about allergies.

Overall, among the 551 respondents, a majority (70%) would like to know more about allergies. We then had the idea to launch a “did you know?” campaign on our social networks.





International survey for iGEM teams

Context

This survey was conducted by our team to study allergies and their perception in the world. This survey was created for iGEM teams to facilitate its dissemination worldwide. We tried to contact the 377 iGEM teams registered this year by email or via social networks. Unfortunately, only 200 teams could be contacted since we did not find a way to contact the other teams. To try to overcome this problem we asked iGEM to release our survey as a collaboration so that it would have greater visibility. Following the release of our survey, we finally obtained 50 participations worldwide. The figures and their analysis presented below were obtained after reviewing these 50 participations.

Given that our project mainly concerns people with food allergies, we looked at the proportion of people having allergies among surveyed teams and the proportion of people suffering from food allergies among the latter. In order to get a more global picture of the proportion of people with food allergies in each country, we asked members of each team how many people with food allergies they knew in their environment. We were curious about the perception of people around the world of food allergies, their dangerousness and the difficulties they can cause. That is why we asked them to estimate on a scale of 1 to 5 the accuracy of food labeling and the life-threatening nature for a person with food allergies in their country.

Geographical distribution

    We encountered several problems regarding the analysis of the results of our survey:
  • We do not have data for each country.
  • Most of the teams that participated in the survey live in United States (6), France (5), Germany (4) and United Kingdom (4).
  • The number of participants is too low to be able to carry out real statistical studies.

The 50 teams that have participated in our survey live in 23 different countries : Australia, Brazil, Canada, China, Costa Rica, Denmark, Finland, France, Germany, Greece, India, Japan, Mexico, Netherlands, Norway, Russia, Singapore, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and United States.

In order to obtain a more relevant analysis, we decided to analyse the responses in terms of participants (total number of members of each team) per country and not per team per country. Since we did not ask for the number of people per team in our survey, we collected this data from the iGEM website.

Allergies

First, we asked the number of allergy sufferers in their team. As a result, we were able to estimate the proportion of allergic people among the respondents worldwide. According to our analysis, 31% of survey participants suffer from allergies, which is slightly higher than estimates made by other organizations (such as AAAAI : American Academy of Allergy Asthma and Immunology) suggesting that 10 to 30% of the world population suffers from allergies.

We then asked ourselves whether this proportion could vary significantly from country to country and therefore represented the number of allergic participants per country.

We can then see that the proportion of allergic people among the respondents can vary enormously from country to country. Indeed, a very low proportion of allergic people can be observed in several countries (especially in Singapore where none of the respondents are allergic) while a very high proportion can be observed in others (such as in Germany and Costa Rica where more than half of the participants are allergic). However, it is noteworthy that in general, countries with a low proportion of allergic people correspond to those for which we have the fewest answers.

We can therefore assume that the difference in the proportion of allergic people between countries could be less significant if we had more data to analyse. This hypothesis seems all the more justified since some of these results cannot reflect reality, particularly Singapore where no one would be allergic according to our results.

Food allergies

Since our kit was initially designed to detect food allergens, we are therefore interested in the number of people with food allergies among the respondents.

By modifying the previous figures to distinguish between people with food allergies and those with other allergies, we were able to obtain this histogram (see next figure). These allow us to have an idea on the number or proportion of people with food allergies among all respondents.

It is important to note, however, that the data we have collected only allow us to know the number of people with allergies and the number of people with food allergies. Thus, people indicated as having food allergies may also have other allergies, which is not indicated in our analysis.

According to research carried out by various organizations, about 10% of the population suffers from food allergies. Looking at our results, it would appear that most of the countries surveyed are following this trend. However, we can observe several aberrations in our results:

  • Some countries do not have people with food allergies (Switzerland, Greece, India and Norway).
  • All respondents in Netherlands and Russia who are allergic are allergic to food.
  • There are no allergic people in Singapore.

We are well aware that these results are not representative and we assume that these aberrations are due to the small number of respondents in these countries.

Then, we wondered what the proportion of people with food allergies was among all allergic people. According to our analysis, 37% of the allergic people among the respondents suffer from food allergies.

In order to have a better idea on the number of people with food allergies in the different countries, we asked each team to answer how many people suffering from food allergies do their team members know. From these data and the number of respondents per team, we were able to calculate an average number of acquaintance suffering from food allergies per participant per country.

It can be seen that overall, almost all respondents know at least one person with food allergies. Surprisingly, the results are less than 1 for several countries and even zero for Taiwan and India. However, it can be assumed that the actual figures are higher than those given below. For instance, several teams had food-allergic members and did not take them into account (i.e Taiwan).

Allergens

According to studies carried out in recent years, about 90% of food allergies worldwide are due to 8 food families ("big 8"): Milk, Eggs, Fishes, Shellfishes and Crustaceans, Tree nuts, Peanuts, Wheat, Soy.

As we wish to produce a food allergen detection kit that could be useful to as many people as possible, we were particularly interested in knowing the allergens responsible for food allergies among the members of the teams surveyed.

In a second step we wanted to determine which food allergies were the most frequent worldwide and whether there was a variation according to the countries.To do this, we asked teams with food allergic people to indicate which foods they were sensitive to. The different allergens have been grouped into categories: the different Big-8 families (Milk, Eggs, Fishes, Shellfishes and Crustaceans, Tree nuts, Peanuts, Wheat, Soy) and other foodstuffs (Other).

By counting the number of allergic teams to the different allergens we estimated the average distribution of food allergens among surveyed teams.

Interestingly, although the majority of declared allergens are part of the Big-8, almost 39% are not. We could attribute the difference with the 10% estimated in the other studies to the fact that we could only obtain one vote per allergen per team when in reality several people per team could be allergic to the same food. To obtain more reliable results, we would need to know how many people per team are allergic to each allergen cited.

We then looked at non-Big-8 allergens and tried to classify them into several families: Fruits, Vegetables, Alcoholic drinks and Honey. We then calculated the rate of these different families among the non-Big-8 allergens. It can then be seen that a large part of these allergens come from fruits (about 70%) or vegetables (about 19%).

List of allergens present in these families:

  • Fruits : Stone fruits, pears, peaches, cherries, blueberries, pumpkins jackfruits, cantaloups, star fruits, coco nuts and eggplants.
  • Vegetables : Raw celery, carrots, taro and cardamum.
  • Alcoholic drinks : Beer and other.

    • Unfortunately, we have not obtained sufficient data to determine whether majority allergens vary from country to country, but other studies have already suggested this.

    Perception of food allergies worldwide

    We know that allergies can be a burden in the everyday life. Due to symptoms that can be uncomfortable or even fatal, it is very important to be informed and protected from allergies. In the case of food allergies, although there are different treatments to desensitize or limit the symptoms of the allergic reaction, the easiest way to protect yourself from these allergies is not to eat food containing the allergens. That is why marketed foods must be properly labelled and all allergens present must be indicated.

    Since the presence of certain allergens in food is not always well indicated in France, we wanted to know if it was the same in other countries, or at least what the feelings of the respondents were on the subject. We asked them to tell us how accurate allergen labelling is in their country on a scale of 1 to 5 (1: not precise and 5: very precise). We then counted the number of votes for each level (1 to 5) and made a representation of the average value obtained per country.

    In view of these results, it would seem that the vast majority of respondents think that allergens are quite well indicated since more than 75% of voters gave a score between 3 and 5 (in particular, 48% of teams voted 4). Interestingly, some teams seem to be dissatisfied with the labelling of allergens in their countries (Brazil, Taiwan, Turkey and India).

    Since food allergies can cause very violent reactions (and can even lead to death) and several factors can increase the risk of an allergic reaction (unknown allergy, allergen not indicated, no possibility of treatment,...), we were interested in the perception that surveyed people have about the dangerousness of food allergies in their country. To do this, we asked the teams surveyed to tell us on a scale of 1 to 5 (1: not dangerous and 5: very dangerous) how dangerous everyday life could be for the citizens of their country with food allergies.

    We then counted the number of votes for each level (1 to 5) and made a representation of the average value obtained per country. The majority of the teams surveyed seems to think that the daily life of citizen with food allergies is not very dangerous since almost 70% of voters have given a score between 1 and 2 and no team voted for 5. However, interestingly, respondents in Brazil, Mexico, Costa Rica and China gave scores above 3.

    To analyze these results, several precautions must be taken:

    • As with the rest of our analysis, the number of respondents is quite low (especially since there is only one vote per team here).
    • People who are not allergic to food are probably not as sensitive to the quality of food allergen labelling or to the life-threatening for people with food allergies as food allergic people (who are in the minority among the respondents).

    Taking these limitations into account, we still think it would be interesting to pursue this study, particularly in those countries that have given low scores to the first issue and high scores to the second one. First, it would be interesting to interview more people to obtain usable data. It would also be interesting to ask them why they find the labelling unsatisfactory (not indicated, indicated in a foreign language, etc.) or why they think that the life of a person allergic to food is dangerous in their country. Then we could carry out a comparative study of the responses given by people who are allergic to food and those who are not.

    To finish our study on the perception of food allergies, we asked the different teams to tell us if they thought the number of people with food allergies was increasing in their country. Several studies carried out in recent years have already shown that the number of people with food allergies is increasing every year. One example is France, where the number of people with food allergies has doubled over the past 5 years.

    Looking at the results obtained, it can be seen that the majority of voters believe that the prevalence of people with food allergies is increasing in their country (62%) while 8% do not think so and 30% do not know about it. Based on our literature searches, we were unable to identify countries where the number of people with food allergies has decreased in recent years. It would therefore seem that 39% of the teams are not well enough informed about the prevalence of food allergies.

    Analysing these results, we believe that it could be interesting to better inform the population about food allergies. This could make it possible to better diagnose and treat them and also to prevent as many incidents as possible related to them (in particular by improving labelling and the quality of life of allergic people in certain countries).

    Respondents' opinions on our kit

    To finish this survey, we asked the teams if they thought that a kit such as the one we imagined could be useful for people with food allergies in their country. We were pleased to note that a large majority of the teams surveyed (80%) believe that such a system could be useful for people with allergies in their country.Although the proportion of teams surveyed who think that such a device would not be useful is low, it would be interesting to contact them again to ask them why they do not agree with the majority, which could allow us to improve our kit.


    Children survey

    We were curious about how allergies are experienced and perceived by 7 to 11 years old children. We also looked at the proportion of children who have a known food allergy and who already had an allergic reaction during meals in different situations (home vs. outside). In the second part of this survey, we investigated the knowledge that these children have about the immune system in general and about allergies.

    The children completed this survey during a summer camp. This allowed us to get 129 participants involved.

    • 1st Grade: 6-7 years old
    • 2nd Grade: 7-8 years old
    • 3rd Grade: 8-9years old
    • 4th Grade: 9-10years old
    • 5th Grade: 10-11years old

    Mostly we got more answers from children aged 9 to 10 years old but we also had some answers from younger children (6-7 years old).

    Firstly, we wanted to know the proportion of them who suffer from allergies.

    Among the 129 children who responded to the survey, 38 (29%) suffers from allergies. This is in accordance with the 30% announced by Inserm.




    We then wanted to know what most of them are allergic to.

    Among the 38 children who suffer from allergies, the large majority is allergic to pollen. In second position, 6 are allergic to food.

    As the symptoms associated with allergies are generally quite distressing, we wanted to know the proportion of allergic children who take treatments to relieve them.

    We have found that only 26% of them were taking a treatment, which may include medication (antihistamines) or desensitization.




    To get an idea of the impact of allergies and related symptoms on the life of allergic children we asked them to indicate on a scale of 1 to 5 how much the symptoms bother them in their daily lives.

    Thus we have seen that none of them are extremely disturbed by their symptoms in their daily lives and that 34% are not disturbed. Most of the allergic children interviewed are moderately bothered by their symptoms. However it is also interesting to note that among the 6 children who answered 4, 4 of them are suffering from food allergies.


    We next wanted to know the proportion of children who had already consulted an allergist.

    Among the 129 children who responded to the survey, 41 have already been to an allergist (32%). However, most of them have never consulted this doctor. Moreover, these data therefore indicate that some non allergic children had already consulted an allergist.




    Most of them consulted the allergist in order to get a medical examination.

    The final objective of our project is the detection of food allergens in order to protect allergic people from a dangerous reaction related to the ingestion of incorrectly indicated allergens. We were therefore interested in the proportion of children with a diagnosed food allergy who already had an allergic reaction during a meal.

    We first wanted to know if they ever had an allergic reaction when they were eating at home.

    And then we compared this proportion when they are eating outside.

    Thus we have noticed that the proportion of allergic children who had an allergic reaction following a meal taken outside is more important than when they eat at home.

    We wanted to know where these reactions have taken place.

    An important part of this survey is to get an idea of then knowledge and awareness that children have about allergies. We firstly ask if they think that the number of people with allergies is increasing.

    Overall, half of the children are aware of the increasing prevalence of allergies. However, the majority don’t know or even is not aware of this problem.




    We then asked them if they want to know more about allergies.

    Globally, the majority is interested. We thus did scientific workshops for children as well as a storybook and a comic book.




    To do this we also wanted to know if the children understand how the body fight against microbes to introduce the notion of the immune system.

    40% of them have no idea how the body fights against microbes.









    A study on the social, economic and legal context

    Genetically engineered organisms (GMOs) as well as synthetic biology as a field of science are still nowadays ongoing debates. The limits of how far synthetic biology could take us as a society are not fully identified yet. That is why law and ethics are only starting to apprehend these new concerns. As far as the public opinion is concerned, fear is still the main feeling related to the acronym GMO. Most of the time, the lack of knowledge and information roots for such a fear. Most people have no idea what genetic engineering really means nor are aware of its place throughout our history.
    As an example, plant breeding is a form of genetic selection ongoing for centuries in agriculture. That is why the iGEM initiative is so important to educate people and communicate our work to non-scientists.

    As far as our triple-hybrid system-based allergen detector is concerned, we have worked on identifying competitors on the market.
    Prevalence of food allergy currently increases to reach out 10% of the population worldwide making it a promising market. Qualitative detection is based on immunochromatographic techniques which can be implemented on a simple strip or a more complex device such as a pregnancy test. ELISA (Enzyme-Linked Immunosorbent Assay) is still the reference when it comes to quantitative results. The state of the art for on-site allergen detection in foodstuffs relies on user-friendly and smartphone-connected devices.
    NIMA is a gluten and peanut portable immunochromatographic detector already commercialized by a company based in San Francisco.
    The Allergy Amulet and the integrated Exogenous Antigen Testing (iEAT) devices should also be shortly available for purchase. These are based on molecularly imprinted polymers and magnetic beads, respectively.

    Our in vivo platform for the detection of allergens bears the advantage of not relying on antibodies whose availability and efficacy might be limited for some molecules. Instead, it uses an aptazyme switch which is an RNA molecule whose price for synthesis continuously decreases with the breakthrough of molecular biology.
    The major obstacle for the commercialization of our device lies in the utilization of GMOs by individuals and on foodstuffs, what indeed vehicles apprehension within the public opinion. Our effort for design of the prototype and for communication should therefore focus on biosafety.
    Regulations given by the European Union are however vague. The directives 2009/41/EC and 2001/18/EC govern the use and the deliberate release of GMOs in the environment, respectively, but they focus on plant GMOs and little is already set for a such GMO-based technology.

    That being said, the underlying molecular mechanism of our system is versatile and could be applied to the detection of other substances such as heavy metals or hormones for environmental purposes. Not only can our system be used by individuals but it also is of great interest for industrials which would dispose of adequate waste treatment facilities.

    Another obstacle that may arise is the requirements for medical devices if AptaTest is recognized as such. The EU Medical Device Regulation 2017/745 defines a medical device as following:
    “‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, - investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, - providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: - devices for the control or support of conception; - products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.”

    The Food and Drug Administration of the United States adopted the following definition of a medical device in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act:
    “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: - recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, - intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or - intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).”

    As the AptaTest does not fall within those two definitions, it is thus not recognized as a medical device and is exempt from European Medical Agency and US Food and Drug Administration controls. Moreover, the Nima sensor, the only allergen detection kit already commercialized, does not mention any classification as a medical device in its CE Declaration of Conformity.