T355

Food Allergen Detection

BMED 4602

Engineering Design Specifications Report

October 1, 2013

Laura Kish

Bryant Menn

Henry Skelton

Editor: Simisola Oludare

Advisor: Karen Harris

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Executive Summary:
Peanut allergy is one of the most common and rapidly growing food allergies in America
1
. 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.

1.1 Functional analysis and points of interaction

The principal function of this product will be to determine the quantity of allergen in a
food sample. To achieve this main function, the product will perform a few sub functions which
involve preparing the food sample, extracting the protein, and performing the analysis. The goal
of the product is to perform all of these functions in a single, self-contained device in order to
streamline the process and make the device simple to use. The straightforward approach to
allergen detection is novel; existing allergen detection systems perform these functions in many
disparate steps.

1.2 Sub functions of the device

The key sub functions of the device’s performance are given below.

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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.

1.2.2 Homogenization of the food sample

The sample (if solid) must be ground into a puree so that the sample is completely
homogeneous. This is necessary to ensure that the food sample used in the test is uniform,
reducing the quantity needed for the analysis as well as the error in the device.

1.2.3 Extraction of the proteins

An extraction buffer will be used to remove the protein from the food sample. This liquid
(now containing protein) will then be analyzed to determine whether or not allergens are present.

1.2.4 Allergen detection

A lateral flow immunoassay (ELISA) strip will be used to determine whether or not
there are allergenic proteins in the extraction fluid. ELISA works by binding the proteins which
cause peanut allergies (such as Ara h1 and Ara h2) to their specific antibodies. After the proteins
have been bound, a color change will occur to indicate the level of protein-antibody bond. This
analysis can either be semi-quantitative or qualitative. If the analysis is semi-quantitative, the
analysis will be colorimetric and a scale will be provided to interpret the quantity of the allergens
present. And if the analysis is qualitative, a single color will indicate whether or not allergens are
present.

1.2.5 Reporting the result

The results will be visually displayed to the user. To ensure clarity, distinct colors will be
used to represent the presence or absence of allergens. The conditions within the device have to
be such that it does not distort the colors. Also, the product will provide a means of documenting
whether or not allergens were detected.

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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.

1.5 Market information and device regulation

Approximately 1% of Americans are allergic to peanuts and/or tree nuts; this equates to
about three million people afflicted 1. According to the 2010 U.S. Census, 49.3% of respondents
reported dining out within the past year 9. Considering that the individuals whom responded to
the survey dined at restaurants several times per month or week, there were well over ten million
instances in which those with peanut allergies risked contact with peanuts or peanut derivatives
in a restaurant setting. The assumption that each device could test the food of ten customers
translates to at least a million possible sales of the units.

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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.

2. Engineering Design Specifications

2.1 Voice of the customer
The primary customers will be commercial food service operations, with a focus on non-
chain restaurants which currently face the greatest challenge in providing allergen-free food.
They will use the product to the benefit of any their customers with peanut allergies and, in the
process, increase their profits and limit the chances accruing losses due to accidental allergic
reactions.

2.1.1 Food service

The intended market for this device is the food service industry. Currently, there is no
requirement for restaurants to label their food for allergens. Some elect to do so, but rely solely
on the labeling of manufacturers and careful monitoring of ingredients similarly patients. This is
very difficult to perform in a busy kitchen environment, and the end result is that the majority of
allergic incidents happen in restaurants. Restaurants can benefit greatly from a test that detects
allergens in their food, particularly if it could be used for large batches of ingredients. However,
restaurants also operate on very limited profits already, and would need something inexpensive.
In addition, they would need something that would be usable and not disruptive in a busy kitchen
environment. It should be totally self-contained, durable, and small enough not to be in the way.
It also needs to be something that restaurant workers could use with minimal training. Most
importantly, any restaurant worker should be able to read the results and definitively understand
if there are peanut allergens present or not.

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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.

2.2 Functional requirements and performance metrics

In order to meet the needs of the customer, functional requirements have been defined
with performance metrics to ensure a defined minimal level of operation.

2.2.1 Homogenization of the food sample

Accurate ELISA test results depend on complete extraction of proteins from food in the
protein extraction buffer. To ensure complete protein extraction, solid food particles will be
processed to a particle diameter of 90 micrometers or less and validated to ASTM E1111.

2.2.2 Minimum allergen detection level

Currently, there is no industry standard defining a minimum allergen detection level for
any food allergen. In a study by Morisset et. al, a detection level of 24 parts per million (ppm) for
peanut allergens was determined to meet the needs of 95% of the peanut allergic population 12. A
review of two ELISA dipsticks demonstrated an allergen sensitivity of 1 ppm in a 100 g of solid
food 13. Detection levels should not be affected by redesign, since design focuses are on ease-of-
use for a larger audience.

2.2.3 Total test time

Initial interviews with a patient and restaurant owner emphasized the importance of a
quick turnaround time while testing for allergens. The use of the device in a fast-paced kitchen
environment also requires that the device return sample results quickly. The current target metric
is estimated at a total test time of 5-10 minutes. Future observations of a kitchen will be made to
confirm or adjust this estimate.

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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 Functional requirements and device characteristics

To ensure proper operations in the environments of the customer, the following
functional requirements and device characteristics have been defined.

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.

2.3.2 Food safety and cleanliness

In order for the device to be safely used in a kitchen, the device will be constructed out of
food-grade plastic as defined by FDA Title 21 Part 177. This will prevent chemicals leaching
from the plastic, which is currently a large public concern. In addition, all reusable portions of
the device must be able to withstand multiple washes in industrial dishwashers to prevent
contamination across samples.

2.4 Design constraints

The primary constraint that this product faces is the difficulty of obtaining a truly
homogeneous sample of the food. This presents a big problem especially in cases of cross-

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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.

3. Manufacturing and Cost Analysis

The device will be manufactured and packaged in a non-sterile but allergen-free
environment. The housing for the ELISA dipstick will be manufactured with injection molding.
Estimates using ABS plastic with 1 million units are $0.586 per unit. The material and methods
used to produce the component that will homogenize the food sample is currently undetermined.
The ELISA dipstick used in this device will be be obtained from a third party producer in order
to reduce the costs of manufacturing it. Estimates for an peanut ELISA dipstick are currently
unavailable, but comparable consumer ELISA dipstick tests range from $8 to $80.

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

Table 1. Functional requirements and corresponding performance metric or characteristic.

Based on the needs of the primary and secondary users, several critical, essential and ideal
functional requirements where determined. These requirements were then defined using
engineering metrics. The most important requirement identified by the users was the sensitivity
of the device, followed by the quickness and cost. The least important requirement was
determined to be the portability of the device.

Standard/
Functional Requirement Importance Performance Metric/Characteristic
Reference

1. Homogenize solid &

Essential a) Solid food particle size < 90 micrometer ASTM E11
liquid foods

a) Minimum detection < 24ppm1 Morisset2,

2. Detect peanut allergens Critical
b) Ideal: 1 ppm Stephan3

3. Analyze food samples

Essential a) Results under 5-10 minutes ---
quickly

National
4. Affordable Essential a) < $2.087 per customer2 Restaurant
Association1

a) No bigger than 1.25” x 1.25” x 6”

5. Portability Want ---
b) Weigh < 0.5 lbs

a) Food-safe plastic FDA Title 21

6. Food Safety Critical
b) Re-usable parts are washable Part 177

Table 2. Competitive products. Existing products for detection of peanut allergens in food.

Company Product Time Price Detection Limit

Veratox for Peanut Available upon

Neogen > 30 min. 2.5-25 ppm
Allergen request *

Reveal for Peanut Available upon

Neogen 10 min. 5 ppm
Allergen request *

Peanut Residue Available upon

ELISA Systems > 30 min. n/a
assay request *

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.