Allergen Seminar - 3M Allergen Test

Allergen Testing for the Food Industry
By Rismalia, M.Biomed, 3M FSD, Senior Technical Support
© 3M 2011. All Rights Reserved.

Food Allergies
 The prevalence of food allergy is estimated to be 1% to

2% of the population1
 Prevalence and severity both seem to be on the rise

– Peanut allergy doubled in children over a five-year period (1997-
2002)
 1 http://www.foodallergyalliance.org/foo.html
Allergy & Intolerance
 Allergy is an immune response to a substance

– Your body actively treating a substance like an
infectious agent.
• Antibodies (IgE) → histamine → swelling/hives/etc.
 Intolerance is a non-immune response to a
substance
– “natural” response to a substance
– Ex. Lactose intolerance
• Lactose not metabolized (lack of enzyme)
• Lactose becomes food for bacteria
• Bacteria produce gas/bloating/etc.
Common Food Allergens (>90% of allergies)
Peanut Shell Fish

Milk Fish
Egg Tree Nut
Wheat Soy
What part of a food is allergenic?
 Milk – Casein  Shell Fish –

 Egg – Ovalbumin Tropomyosin
 Wheat – Gluten  Fish – Parvalbumin
 Soy – Soy protein  Peanut – Ara H 2
 Tree Nut – vicilins,
legumins, 2S
albumins
3M ALLERGEN TEST
6
PRINCIPLE OF THE TEST
 Allergen protein is heat stable

 Aller-tect chemistry is based on the Biuret reaction.
Under alkaline conditions the copper ions (Cu2+) form
a complex with peptide bonds of protein and become
reduced to Cu+.
 Bicinchonic acid (BCA) under alkaline conditions is a
highly sensitive, stable and specific reagent which
forms a purple complex with Cu+. The test provides an
estimation of protein by means of a colour change.
7
Swab for the detection of protein residues
Aller-tect™ can be used to detect protein residues on
surfaces and in solution, and thereby determine if cleaning
has been effective in eliminating proteins, including
potentially allergenic proteins contamination.
 ALLTEC60 detected 3~10 μg of protein at least for every

food and the reagent color changed from green to gray.
 ALLTEC60 determined up to 300 μg of protein at most
 These products enable to detect the allergen residue
more easily and more rapidly. These are effective for
daily cleaning inspection as allergen contamination
8 control.
HOW TO TAKE THE SAMPLE
Surfaces Solutions
 Use the moisturizer  A wide range of solutions
provided; apply 4 drops to can be applied to the
the swab OR apply 4 swab.
drops to the surface to be  If process rinse samples
tested. are tested, the solution
 Define the area to be should be pre-tested for
swabbed, then swab the the presence of sanitizing
surface thoroughly, in a agent (e.g. pH check).
firm criss-cross motion,  Dip the swab into the
rotating the swab to use sample and remove any
the entire surface. excess liquid on the side
of the vessel.
9
HOW TO DO THE TEST
Click
 Firmly press down the handle
into the swab and shake
rapidly from side to side for at
least 5 seconds. The solution
will turn pale green.
Heat
 Place the Aller-tect swab into
the heating block.
 Heat for 15 minutes at 55ºC.
Read
 After the 15 minute heating
step, compare the colour of the
solution against the color chart
on the Aller-tect label.
10
INTERPRETATION RESULT
Green - Pass
Grey – Caution
Purple - Fail
The color of the test reaction will indicate the level of protein residues.
• Green indicates a PASS result. No further action required.

• Grey is inconclusive and we recommend re-cleaning and re-testing.
• Purple indicates a FAIL. Re-clean and re-test.
Semi-Quantitative Test
 darker color/faster color development =>

more protein present
12
RANGE COLOR
13
3M Clean-Trace Surface Protein (Allergen) Test
 Not specific to Allergens – this is a

total protein allergen test
 No protein = No allergenic proteins
 Only for environmental samples –
can’t find allergens in a product
sample
VALIDATION DATA
Reference Material
Allergen Detection Limit Material Used Protein Content (%)
Egg 10-20μg NIST SRM8415 30

Whole egg powder
Milk 10-20μg NIST SRM8435 25.9

Whole milk powder
Peanut 25-50μg NIST SRM2387 22.2

Peanut butter
Gluten 40μg Gluten flour ~83

(locally sourced)
Soy 20-40μg Soy flour ~46.5

(locally sourced)
Almond 20-40μg Whole almond ~19.5

(locally sourced)
Buckwheat 20-40μg Buckwheat flour ~13

(locally sourced)
Typical Applications during Cleaning
Application Sites
US Customer
3MUS
escription ID Customers
Number Names 3M ID Description
US Customers Names US Customer Names
60 SURFACECHEESECAKE
PROTEIN FACTORY
GH620535282 (ALLERGEN)
INC-3MID- SURFACE
ALLTEC60 GH620522462
WILD FLAVORS
PROTEIN (ALLERGEN) -3MID-
CHEESECAKE
GH620535282 115940726
FACTORY INC
H E BUTT GROCERY CO WAWONA FROZEN FOODS INC H E BUTT GROCERY CO
PRIME PAK FOODS INC VERMONT BREAD COMPANY PICTSWEET FROZEN FOODS
PICTSWEET FROZEN FOODS TURKEY VALLEY FARMS COALESCENCE LLC
COALESCENCE LLC THE KROGER CO EAST COAST FRESH CUTS
EAST COAST FRESH CUTS THE CARRIAGE HOUSE CO J R SIMPLOT CO
J R SIMPLOT CO SUPERIOR FOODS INC WEIS MARKETS INC
WEIS MARKETS INC SUNNY FRESH FOODS SUNOPTA INGREDIENTS
TRIUMPH FOODS LLC SPECIALTY BRANDS INC SOKOL & COMPANY
SUNOPTA INGREDIENTS SCHIFF NUTRITION GROUP HERITAGE FOODS
NELLSON NUTRACEUTICAL REALLY COOL FOODS LYONS-MAGNUS
SOKOL & COMPANY POUCHTEC INDUSTRIES LLC HYDROBLEND INC
HERITAGE FOODS LYONS MAGNUS
PBM NUTRITIONAL LLC
PURE PAK INC KENS FOODS INC
WINDSOR FOODS
LYONS-MAGNUS ISABELLES KITCHEN INC
ELI'S CHEESECAKE
HYDROBLEND INC GREAT NORTHERN BAKING CO
DAIRY FARMERS OF AMERICA
PBM NUTRITIONAL LLC G & S FOODS INC
THE MUSHROOM CO
WINDSOR FOODS FLOURS BAKING CO
READY FOODS INC ESSEN NUTRITION CORP
STEVEN ROBERT ORIGINALS
ELI'S CHEESECAKE DESIGNING HEALTH INC VENTURA FOODS INC
BELLISIO FOODS LAKEVILLE CONAGRA GROCERY PRODUCTS SHAWS SOUTHERN BELLE
NEW SEASONS FOODS CAROLINA FOODS INC RUTTERS DAIRY
DAIRY FARMERS OF AMERICA CARGILL FLAVOR SYSTEMS MCCALL FARMS INC
THE MUSHROOM CO BURGER MAKER CO INC WATSON FOODS CO INC
STEVEN ROBERT ORIGINALS BRIGHT HARVEST SWEET NATIONAL FROZEN FOODS
HOUSE OF RAEFORD BAY VALLEY FOODS MADISON CHEMICAL CO INC
CREATIVE FOOD INGREDIENT APIO INC (VALUE ADDED) DUTCH VALLEY FOOD INC
CORNFIELDS INC AMERICAN IMPORTING CO WIMMERS MEAT PRODUCTS
COMPLETELY FRESH FOOD ADAM NUTRITION INC TURKEY VALLEY FARMS
BEAUTIFULL INC NELSON JAMESON INC SUPERIOR FOODS INC
MORNINGSTAR SPECIALTY THE PICTSWEET CO ISABELLES KITCHEN INC
VENTURA FOODS INC JUICE HARVEST CORP BRIGHT HARVEST SWEET
SHAWS SOUTHERN BELLE E A SWEEN CO MINN 3M DE COLOMBIA SA
RUTTERS DAIRY CONAGRA STORE BRANDS VICTORIA PACKING CORP
MCCALL FARMS INC MINN 3M DE COLOMBIA SA RICH ICE CREAM
HANOVER CONSUMER COOP MADISON CHEMICAL CO INC POLKS MEAT PRODUCTS INC
GOOD HUMOR-BREYERS ICE LITTLE LADY FOODS PAPYS FOODS INC
ENGELHART GORMET FOODS FIRST CLASS FOODS MARJON SPECIALITY FOODS
DAVID MICHAEL & CO INC FIRMENICH INC MANCHESTER FARMS INC
COLEMAN NATURAL FOODS EDEN FOODS INC INNOVATIVE FLEXPAK
ABBYLAND FOODS INC DANISCO USA INC INDUSTRIAL & COMMERICAL
MISTER COOKIE FACE INC BAKERY ON MAIN DAVISCO FOODS
WATSON FOODS CO INC HYDROBLEND CUSTOM FOOD PRODUCTS INC
PURATOS CORP DUTCH VALLEY FOOD INC
CC POLLEN CO
PRO VIEW FOODS VENTURA FOODS LLC
CARGILL
NATIONAL FROZEN FOODS WINDSOR FOOD
CACHE CREEK FOODS INC
MEIJER INC
BYBEE FOODS LLC
MARICH CONFECTIONERY CO
BALCHEM CORPORATION
APAC Customer
Thailand
Seafood Meat Poultry Dairy Fruit& Vegetable Seasoning Other
ASIA PACIFIC (THAILAND) CO.,LT B.FOODS PRODUCT INTERNATIONALC CHOMTHANA CO.,LTD RIVER KWAI INTERNATIONAL FOOD FOOD AND DRINKS PUBLIC CO.,LTD CADBURY ADAMS (THAILAND) CO.,L
ASIAN ALLIANCEINTERNATIONAL CO GFPT PUBLIC CO.,LTD. GREEN SPORT CO.,LTD. SWIFT CO.,LTD. GLOBO FOODS LTD. HERITAGE SNACKS & FOODS CO.,LT
ASIAN SEAFOODS PUBLIC CO.,LTD. GRAMPIAN FOODS SIAM CO.,LTD. THAI AGRI FOODS PUBLICCOMPANY KIJBANLUE MULTI-FOOD CO.,LTD. PEPSI-COLA (THAI) TRADING CO.,
KIBUN (THAILAND) CO.,LTD. KAONA POULTRY CO.,LTD. THEPPADUNGPORNMAPRAO CO.,LTD NAMPRIK MAESRI LTD.,PART. VITTAYASOM SRIRACHA CO.,LTD
LUCKY UNION FOODS CO.,LTD. THAI-NICHI INDUSTRIES CO.,LTD. WIN CHANCE FOODS CO.,LTD. SOUTHEAST ASIAN PACKING ANDCAN
N & N FOODS CO.,LTD. LAMPANG FOOD PRODUCT CO.LTD(FA YAN WAL YUN CO.,LTD. TOYO PACK INTERNATIONAL CO.,LT
SEA WEALTH CO.,LTD. PROPLAN INSUSTRIAL CO.,LD. UNI-PRESIDENT (THAILAND) LTD.
SEAFRESH INDUSTRY PUBLIC CO.,L PAN SIAM FOOD PRODUCTS CO.,LTD
SONGKLA CANNING PUBLIC CO.,LTD R & B SUPPLY CO.,LTD BRANCH 00
SOUTHEAST ASIAN PACKAGING ANDC R & B SUPPLY CO.,LTD.
SURAPHOL SEAFOODS CO.,LTD
SURAPON NICHIREI FOODS CO.,LTD
THAI DELMAR CO.,LTD.
THAVEEWONG INDUSTRIAL CO.,LTD
INTER-PACIFIC MARINE PRODUCTSC
Indonesia:
1.Sumber Inti Pangan
2. FIRMENICH AROMATICS INDONESIA
3. VESTA MITRA MANDIRI
4. KELOLA MINA LAUT
5. PUTRA MANDIRI SEJATI
6. SARANA KARYAPUTERA MANDIRI
 “In the United States, the Food and Drug Administration
(FDA) regulates packaged food. FDA regulations require
that protein-containing ingredients derived from the top
eight allergens (milk, egg, wheat, peanut, soy, tree nut,
fish, and crustacean shellfish) be identified by their
common or usual name.”
– http://www.foodallergyalliance.org/foo.html
Testing strategies for environmental contamination
 Head-in-the-sand
 Visual
 Specific Allergen Test
– ELISA / Lateral Flow
 Allergen Indicator Test
– ATP
– Protein
ELISA (Enzyme Linked Immuno-Sorbant Assay) Test
 Detect presence of protein by making an antibody

sandwich & detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
* * *
* ** *
YYYYYY YYYYYY
ELISA Method to detect environmental allergen
 Positives
– Specific – you know if you have a positive result that there
definitely is THAT allergen present
 Negatives
– Specific – you have to run 1 test for EVERY allergen you want to
test for…
– Expensive - $5-$8/test
– Time
• ELISA – 1-2hr
• Lateral Flow – faster, but less sensitive
ATP as a marker for allergenic residues
 Positives
– Rapid
– Usually there’s also ATP in a source of Allergens e.g. Peanuts
have both ATP and Peanut protein
 Negatives
– Not ALWAYS ATP and Protein present
– ATP is hydrophilic – dissolves easily
– Many proteins are “sticky” – e.g. Egg white…do not dissolve
easily – especially when “cooked on” to a surface
Protein as a marker for Allergenic residues
 Positives
– No protein = No allergenic proteins
– Fast - ~15 minutes
– Sensitive - ~10-20 ug/100cm2
 Negatives
– Positive – you don’t know what protein it is?
• Allergen/non-allergen?
Comparison of Methods for Allergen Residue Detection
3M Clean-Trace
Surface
Protein (Allergen)
Comparison of Methods for Allergen Residue Detection
 Various dilutions of a solution of allergen (egg, milk, or

peanut) was spread onto several plates made of one of
three materials (Stainless Steel, Urethane, Teflon)
 The plates were baked at 80ºC
 The plates were swabbed and analyzed following
manufacturer’s directions
MILK
EGG
PEANUT
FDA Study Conclusions
 ELISA methods was than

Visual with most residues and on most
surfaces
 ATP method was than

Visual with egg residues and on all
surfaces tested
 Protein tests are the

predictor of allergenic residues on
surfaces
“What if I’m using fruit – it doesn’t have protein”
 If it is/was alive…it has

protein…
 e.g. Orange Juice
33
Product Constitution
 Packaging
 Colorimeter
 USB-mini5 pin cable
 Charger
 Manual (Korean and English)
 CD
3M CleanTraceTM Colorimeter
Features:
3M CleanTraceTM Colorimeter software
• Data Export to MicrosoftTM Excel
• Clear LCD Screen
• Relative Color Unit (RCU) reading
3M CleanTraceTM
• Surface Protein Instant compatible with
PRO50, PRO100, ALLTEC60 and MPRO050
Fastest Time To Result
• 10seconds to 1minute 45 seconds
Three modes of usage:
1.Normal mode (10min delayed reading)
2.Quick Mode ( Instant results )
3.Log Mode (Recording / Recall of results)
3M CleanTraceTM Colorimeter - Test Process
Need
0~149 150~299 300~449 450~ Cleaning/Washing
V Clean Caution X Contaminated XX Highly contaminated
record the reagent color as 0~600 RCU (Relative Color Unit).
Benefits:
Rapid (1~2minutes to get result)
Ease of Use
Sensitive and Quantitative
Data management using PC
Need
0~149 150~299 300~449 450~ Cleaning/Washing
V Clean Caution X Contaminated XX Highly contaminated

Converting RCU into Protein amount
Func key
Please use BSA amount as just reference

EMC/EMI Certification
 CE Mark (Completed before July)
 FCC/VCCI
– Testing by Korean team
– (Registration by Japan team)
Research at Japan using 3M Alltec60
Yuji Kanai, Research and Development Dept., 3M Health Care Limited, Japan
http://www.metro.tokyo.jp/INET/OSHIRASE/2012/02/DATA/20m2t300.pdf
Protein Egg Milk Wheat Buckwheat Peanut Shrimp Soybean (Standard)

[μg]
Sample Powder Skimmed Wheat Buckwheat Peanut Shrimp Soybean BSA

egg white milk gluten flour paste flour
300
100
30
10
3
0
40
Conversion Protein Allergen (ug) to RCU
Protein Egg White [μg] ALLTEC60 [RCU]
2163 600
1189 600
800 600
216 574
119 477
80 445
22 359
Protein Skimmed 12 315 Protein Buckwheat Flour
Milk [μg] ALLTEC60 [RCU] 2 138 [μg] ALLTEC60 [RCU]
906 600 328 600
0 49
91 466 180 558
50 428 Protein Wheat Gluten [μg] ALLTEC60 [RCU] 33 412
34 403 1820 600 18 393
9 272 1001 600 12 355
5 182 673 588 3 159
1 46 182 507 2 99
0 51 100 440 0 19
67 410
18 282
Protein Peanut
10 160 Protein Soybean Flour [μg] ALLTEC60 [RCU]
[μg] ALLTEC60 [RCU]
2 70 795 600
623 544
0 38 437 600
342 527
62 409 Protein Shrimp Paste [μg] ALLTEC60 [RCU] 80 411
34 367 667 592 44 401
23 341 367 467 8 158
6 167 67 386 4 107
3 117 37 352 1 68
0 19 7 82 0 19
4 78
1 27
0 19
41
Research at Australia using 3M Alltec60
 Title: Sensitivity of 3M™ Clean-Trace™ surface protein (allergen)

swabs to fish derived proteins.
 By: Scott Egan, 18th April 2012
 Objectives: To determine the limit of sensitivity of the 3M Clean-
Trace surface protein (allergen) swab when used to detect protein
derived from fish sources.
 Results: The 3M Clean-Trace surface protein swab (allergen) had a
limit of sensitivity of <10μg of fish derived protein on all surface
types tested. The results show that the sensitivity of the assay, when
removed from the inconsistencies associated with surface sampling
is <5μg and such results are achievable with some surface types.
Sampling Surface Sensitivity (μg)
Direct <5
Stainless Steel <10
Plastic <5
42
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Allergen Testing for the Food Industry

By Rismalia, M.Biomed, 3M FSD, Senior Technical Support

© 3M 2011. All Rights Reserved.

 The prevalence of food allergy is estimated to be 1% to

 Prevalence and severity both seem to be on the rise

 Allergy is an immune response to a substance

Peanut Shell Fish

 Milk – Casein  Shell Fish –

 Allergen protein is heat stable

 ALLTEC60 detected 3~10 μg of protein at least for every

• Green indicates a PASS result. No further action required.

 darker color/faster color development =>

 Not specific to Allergens – this is a

Allergen Detection Limit Material Used Protein Content (%)

Egg 10-20μg NIST SRM8415 30

Milk 10-20μg NIST SRM8435 25.9

Peanut 25-50μg NIST SRM2387 22.2

Gluten 40μg Gluten flour ~83

Soy 20-40μg Soy flour ~46.5

Almond 20-40μg Whole almond ~19.5

Buckwheat 20-40μg Buckwheat flour ~13

 Detect presence of protein by making an antibody

 Various dilutions of a solution of allergen (egg, milk, or

 ELISA methods was than

 ATP method was than

 Protein tests are the

 If it is/was alive…it has

V Clean Caution X Contaminated XX Highly contaminated

record the reagent color as 0~600 RCU (Relative Color Unit).

V Clean Caution X Contaminated XX Highly contaminated

Please use BSA amount as just reference

 CE Mark (Completed before July)

Protein Egg Milk Wheat Buckwheat Peanut Shrimp Soybean (Standard)

Sample Powder Skimmed Wheat Buckwheat Peanut Shrimp Soybean BSA

 Title: Sensitivity of 3M™ Clean-Trace™ surface protein (allergen)

Stainless Steel <10

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