Professional Documents
Culture Documents
BMED 4602
October 1, 2013
Laura Kish
Bryant Menn
Henry Skelton
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Executive Summary:
Peanut allergy is one of the most common and rapidly growing food allergies in America
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. For allergic individuals, accidental exposure to peanuts is often a major health crisis -
sometimes a deadly one. The most common source of accidental exposure is food prepared by
commercial food service, such as restaurants and dining halls 2. This risk reduces the willingness
of allergic individuals to patronize these establishments and imposes upon them a direct financial
burden caused by lawsuits over allergic incidents. Despite this, there is no system available on
the market to test for food allergens outside of industrial and laboratory settings 3. Food service
and consumers have to rely on labelling and ingredient tracking, which is very challenging in a
busy commercial kitchen, not to mention the incidence of incorrect labelling 4. The goal of this
project is to develop a self-contained device that can detect the presence of trace amounts of the
peanut allergens that trigger allergic reactions. This device will be primarily used in the kitchens
of food service companies by their employees to test whether or not homogeneous batches of
food contain peanut allergens. The critical functional requirement of this device is that it should
be able to detect a minimum of 5 ppm of peanut allergens and clearly display the results. Other
essential functional requirements are being able to effectively homogenize the food sample, a
quick turn-around time for the test, and being practical and non-disruptive to use in a restaurant
environment. The primary constraints in creating the device are minimizing both the cost and the
size. The successful implementation of this device in the foodservice industry will result in
reduced cases of allergic reactions at restaurants and schools, which will help businesses by
increasing the confidence of allergic customers in the safety of the food being sold. It will also
reduce the costs associated with litigation. In so doing, it will be of great value to the foodservice
industry and will allow patients to eat more comfortably outside their homes.
1. Project Description
Peanut allergies constitute a major health problem. About two million Americans are
allergic to peanuts, and it is one of the most likely to result in an allergic incident 1. It is caused
by a number of proteins present in peanuts that trigger a major immune response in allergic
people. The reactive portions of these proteins, called epitopes, are very stable and usually
persist through processing or cooking. Due to the stability of these proteins and the often
miniscule amount of allergen needed to trigger a reaction, allergic reactions can occur from
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accidental ingestion of peanuts. These reactions can be very serious, including anaphylactic
shock. Allergic reactions to peanuts require immediate treatment with epinephrine and can
require hospitalization. Some reactions are fatal, even with treatment 1.
Despite the danger posed by peanut allergy, there is no direct way to detect peanut
allergens outside of major industrial food processing 3. There are currently very effective
immunoassays, but they are only sold as scientific supplies and are only usable in a bench
environment by trained scientists or technicians. However, a majority of allergic incidents occur
at restaurants where the personnel are neither qualified to perform these tests nor have the time to
do so in a busy and complex kitchen. Thus, they have to rely on labeling and ingredient tracking
which is often inaccurate and also very inefficient4. This hinders their ability to safely provide
food and maintain consumer confidence, as well as avoiding litigation.
With such a problem in mind, the goal of this project is to develop a solution that allows
restaurants to test for allergens in their food. There is extensive precedent for the development of
simplified immunoassay-based products for use outside of a laboratory, including many
pharmacy tests (i.e. pregnancy tests). The solution will be similar to the devices currently
available to laboratories, but this device will meet the particular needs of the foodservice
industry by consolidating all the lab processes into a simple system.
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1.2.1 Sampling the food
To adequately determine the amount of allergen present in food, a substantial amount has
to be sampled. At this stage, it is important that the user consistently input the correct quantity of
the sample.
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1.3 Points of interaction
This product will be primarily used in the kitchen of a food service company (such as a
restaurant or a school dining hall) after food has been prepared. Due to the high levels of activity
in the kitchen, the device must be designed so that it does not interrupt ordinary operation. The
primary end users of the product will be employees of a food service company who, with
minimal training or prior knowledge of the device, should be able to accurately test and interpret
the results.
1.4 Stakeholders
Foodservice industry will greatly value this product because it will provide them with a
means of properly detecting and documenting which foods possess known allergens. This will
reduce the incidences of allergic reactions and thus, the amount of food allergy-related lawsuits.
Currently, the amount of annual losses due to food allergic reaction lawsuits range from about
$30,000 to $10 million in damages 5, 6, 7. With the use of this device, this number should drop
substantially. Also, the use of this device will provide the food service workers with more
information that they can employ in disclosing the ingredients of their food with customers. The
value of this product goes beyond the primary end users, as it will provide value to patients and
allergists alike. Approximately 80% of all allergic individuals are at risk of anaphylactic
reactions that can be fatal upon contact with trace amounts of allergen 8. Both patients and
allergists have noted that the greatest issues arise in restaurants, either due to the employees not
knowing what ingredients the food contains or poor labelling. The use of this product will lend
peace of mind to allergic individuals eating outside of the home.
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Current products are targeted towards the food production industry, with ELISA-based
allergen detection tests to be performed in a laboratory setting. These tests in their current state
would not translate well to home use, as they typically involve an entire suite of reagents and
vials, making them unreasonable for layperson use (Addendum, Table 2).
Devices for testing levels of allergens present in food are currently not regulated by the
Food and Drug Administration (FDA). The FDA relies on third parties to verify food ELISAs as
standards for testing 10.
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2.1.2 Customers with food allergies
While not being targeted as direct buyers of our product, the ultimate beneficiary is food-
allergic individuals. They would not need to directly interact with the device, and their primary
concern would be that the sensitivity is sufficient to avoid false negative results that could lead to
an allergic reaction. The test would also need to be able to detect the multiple proteins associated
with peanut allergens. The confidence of this audience in the product would be central to the
buyers’ interest in it.
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2.2.4 Affordability
A 2010 report by the National Restaurant Association in partnership with Deloitte stated
that the average restaurant income before tax is 3.0% of sales 14. Estimates using these numbers
show an average income of $2.87 per customer. In order to be a viable product for the
foodservice industry, the device needs to cost much less than the average income per customer.
This translates to a device cost less than $20.87, assuming a single device could test for ten
customers. Maximum cost estimates will be refined further with more observations and
interviews of food service personnel and owners.
2.3.1 Portability
The redesign of ELISA assays should minimize the change in workflow in a food service
kitchen to maximum the ease of use. This will be done by making the device portable, allowing
kitchen personnel to use the device wherever is most convenient. From sampling different device
sizes and weights, a device smaller than 1.25 in. diameter and 6 in. length and less than 0.5 lbs.
would be ideal.
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contamination where the source of the allergen is saturated in most of the food but present in
only a small quadrant of the food. This a difficult problem that cannot be currently circumvented
except with an instruction to users to sample a good representative of their food. Another major
constraint to this product is the re-usability and its effects on cost. Several of the components of
the device will be exposed to allergens and will have to be replaced after each use to in order to
preserve accuracy. The only component exempt from single use is the piece that homogenizes
the food sample. However, even if this component is sufficiently cleaned, it is subject to wear
and tear. The last major constraint to this device will be making it less bulky due to the many
components which it will possess. As such, the device may serve as a hindrance in the workflow
of the kitchen.
4. Project Plan
To successfully develop this device, the team will meet with a few companies in the
foodservice industry in order to determine more of the customer’s needs. Following this step, the
brainstorming process will commence and possible designs for the device will be formulated.
During this process, the team will work towards acquiring the necessary components for creating
the device, especially the ELISA dipstick test. After being acquired, the dipstick will be reverse
engineered and similar component will be implemented into the device. Following the idea
generation process, the final design will be documented via CAD drawings. A model and an
alpha functional prototype will be created to serve as a proof of concept. The model and
prototype will be presented to our advisor and our potential customers (foodservice industry
companies) for feedback regarding its functionality and design. The functionality of the device
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will be tested within the context of a restaurant’s kitchen to model the actual environment it is
designed for. Potential customers will then be given anonymous surveys in order to gauge how
the device performed in the metrics of convenience and ease of use. After evaluating the
feedback, the final prototype will be created and presented at the Capstone Design Expo. The
success of this project will be evaluated based on how well the device is able to meet the team’s
functional expectations, and the feedback that is received from the potential customers and the
team advisor. During the design process, the team will provide weekly updates to the advisor and
also to the teaching assistant. The team will also plan to have bi-weekly meetings with the
advisor to ensure that we are on track to meet the goals for the project. The team goals, including
the expected date of completion, are presented in the team’s Gantt chart (Addendum, Figure 1).
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References
1. Al-Ahmed, N., Alsowaidi, S., & Vadas, P. Peanut allergy: an overview. Allergy Asthma
Clin Immunol. 2008; 4(4), 139–43.
2. Furlong, TJ, DeSimone, J., Sicherer, SH. Peanut and tree nut allergic reactions in
restaurants and other food establishments. J Allergy Cln Immunol. 2001; 108(5): 867-70
3. Nogueria M, McDonald R, Westphal C, Maleki SJ, Yeung JM. Can Commercial Peanut
Assay Kits Detect Peanut Allergens. J AOAC Int. 2004; 87(6):1480-1484
4. Recalls, Market Withdrawals, & Safety Alerts.
http://www.fda.gov/Safety/Recalls/default.htm. Updated 2013. Accessed September 25,
2013.
5. Jalonick, MC. Food service vulnerable to food allergy lawsuits. USA Today. Jan 18,
2013: http://www.usatoday.com/story/news/nation/2013/01/18/food-service-allergy-
lawsuits/1845335. Accessed September 25, 2013
6. Allergy Injury Attorney. http://www.klinespecter.com/allergy_injury_attorney.html.
Updated 2013. Accessed September 23, 2013.
7. Smith, B. Peanut allergy at center of federal civil rights lawsuit for Michigan elementary
student. MLive. Aug 13, 2013:
http://www.mlive.com/education/index.ssf/2013/08/peanut_allergy_at_center_of_fe.html.
Accessed September 23, 2013.
8. About Food Allergies. Food Allergy Research and Education Web
Site.http://www.foodallergy.org/about-food-allergies Updated 2013. Accessed September
9, 2013
9. Adult Participation in Selected Leisure Activities by Frequency 2010.
http://www.census.gov/compendia/statab/2012/tables/12s1240.pdf Updated 2013.
Accessed September 30, 2013.
10. Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food.
Appendices.http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulato
ryInformation/Allergens/ucm106577.htm. Updated 2013. Accessed September 30, 2013.
11. ASTM Standard E11-0e19. Standard Specification for Woven Wire Test Sieve Cloth and
Test Sieves. West Conshohocken, PA: ASTM International; 2012. 10.1520/E0011-09E01
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12. National Restaurant Association. Restaurant Industry Operations Report. 2010.
13. Morisset, M., Moneret‐Vautrin, D. A., Kanny, G., Guenard, L., Beaudouin, E., Flabbee,
J., & Hatahet, R. Thresholds of clinical reactivity to milk, egg, peanut and sesame in
immunoglobulin E‐dependent allergies: evaluation by double‐blind or single‐blind
placebo‐controlled oral challenges. Clin Exp Allergy, 33(8), 1046-1051.
14. Stephan, O., Möller, N., Lehmann, S., Holzhauser, T., & Vieths, S. (2002). Development
and validation of two dipstick type immunoassays for determination of trace amounts of
peanut and hazelnut in processed foods. Eur. Food Res. Technol, 215(5), 431-436.
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Addendum
Standard/
Functional Requirement Importance Performance Metric/Characteristic
Reference
National
4. Affordable Essential a) < $2.087 per customer2 Restaurant
Association1
Table 2. Competitive products. Existing products for detection of peanut allergens in food.
Available upon
r-biopharm Lateral Flow Peanut 10 min. 5 ppm
request *
*The prices for the following ELISA kits were requested ahead of time but quotes have not yet been received.
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Figure 1. Project Gantt chart. The goals and deliverables, as well as the dates of inception and completion, for
this project are listed below in the team Gantt chart. The black bars represent the deliverables for the BMED
4602: Capstone Design course and the blue bars represent the team’s goals.