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individuals following a gluten-free diet. Some of these foods
are shown in Table 2, and represent potential products that
could have cross-contaminated starting materials. This list is
not exhaustive and there may be examples more appropriate for
a specific jurisdiction.
Conclusions
Intolerance to gluten (celiac disease) requires the strict
avoidance of gluten sources from wheat, barley, rye, or their
crossbred species. Codex Alimentarius recommends that for a
food to be labeled gluten-free, it must not contain more than
20mg gluten/kg of food. The food allergen analytical community
is endeavouring to create harmonized guidelines for food
allergen ELISA methodologies to help protect food-sensitive
consumers and promote consumer confidence. The guidance
described here reflects a consensus reached, through input
and collaboration, from various allergen analytical experts,
and contains specific recommendations and requirements
for the validation of ELISA methods for the detection and
quantification of gluten proteins in food matrixes. Future work
is planned for the implementation of this guidance document
for the validation of gluten methods and the creation of gluten
reference materials.
Acknowledgments
With the support of the AOAC Food Allergen Community,
the Gluten Working Group represents major food allergen test
kit manufacturers and experts from regulatory agencies in
Europe, Australia, Japan, Canada, and the United States.
The participation of the following collaborators is greatly
appreciated.
Mark Ross, Sara McGrath, Eric Garber, and Girdhari Sharma,
U.S. Food and Drug Administration, College Park, MD
Armen Mirzoian, U.S. Alcohol Tobacco Tax and Trade
Bureau, Beltsville, MD
Stanley Bacler and Jean-Marc Gelinas, Food Directorate,
Health Products and Food Branch, Health Canada, Ottawa,
Canada
Joyce Boye, Agriculture and Agri-food Canada, St. Hyathen,
Canada
Philippe Delahaut, CERGroupe–Laboratoire d’Hormonologie,
Marloie, Belgium
Michael Minster, Erica Welker, Hannes Binder, Richard
Fielder, and Elizabeth Halbmayr, Romer Labs, United States
and Europe
Mohamed Abouzied and Tony Lupo, Neogen Corp., Lansing,
MI
Sigrid Haas-Lauterbach and Ulrike Immer, R-Biopharm AG,
Darmstadt, Germany
Laura Allred, Elisa Technologies Inc., Gainesville, FL
Mike Ryan, Elisa Systems Pty, South Brisbane, Australia
Masahiro Shoji and Hirotoski Doi, Morinaga Institute of
Biological Science, Inc., Yokohama, Japan
Adam Latawiec, AB Sciex, Concord, Canada
Thomas Grace, Bia Diagnostics LLC, Burlington, VT
Robin Sherlock, Food Allergen Control Training Analysis
Pty Ltd, Tennyson QLD, Australia
References
(1) Catassi, C., & Fasano, A. (2008) Curr. Opin. Gastroenterol. 24,
687–691
(2) Rubio-Tapia, A., & Murray, J.A. (2010) Curr. Opin.
Gastroenterol. 26 , 116–122
MOG.0b013e3283365263
(3) Hernandez, L., & Green, P.H. (2006) Curr. Gastroenterol. Rep.
8, 383–389
(4) Sollid, L.M. (2002) Nat. Rev. Immunol. 2, 647–655. http://
(5) Farrell, R.J., & Kelly, C.P. (2002) N. Engl. J. Med. 346,
180–188
(6) Codex Alimentarius Commission (2008) Foods for Special
Dietary Use for Persons Intolerant to Gluten, Rome, Italy
(7) Official Methods of Analysis (2005) 18th Ed., AOAC
INTERNATIONAL, Gaithersburg, MD
(8) Thompson, M., Ellison, S.L.R., & Wood, R. (2002) Pure
Appl. Chem. 74, 835–855.
pac200274050835
(9) Abbott, M., Hayward, S., Ross, W., Godefroy, S.B., Ulberth, F.,
Van Hengel, A.J., Roberts, J., Akiyama, H., Popping, B., Yeung,
J.M., Wehling, P., Taylor, S.L., Poms, R.E., & Delahaut, P.
(2010) J. AOAC Int. 93, 442–450
(10) Skerritt, J.H., & Hill, A.S. (1990) J. Agric. Food Chem. 38,
1771–1778
(11) Valdés, I., Garcia, E., Llorente, M., & Méndez, E. (2003)
Eur. J. Gastroenterol. Hepatol. 15, 465–474.
org/10.1097
(12) Dewar, D.H., Amato, M., Ellis, H.J., Pollock, E.L., Gonzalez-
Cinca, N., Wieser, H., & Ciclitira, P.J. (2006) Eur. J.
Gastroenterol. Hepatol. 18, 483–491
(13) Wieser, H. (1998) Eur. Food Res. Technol. 207 , 128–132
(14) Official Methods of Analysis (2002) AOAC INTERNATIONAL,
Gaithersburg, MD, Appendix D
(15) Bai, J.C., Fried, M., Corazza, G.R., Schuppan, D., Farthing,
M., Catassi, C., Greco, L., Cohen, H., Ciacci, C., Eliakim, R.,
Fasano, A., González, A., Krabshuis, J.H., & Lemair, A. (2013)
J. Clin. Gastroenterol. 47, 121–126.
MCG.0b013e31827a6f83
(16) Wieser, H., & Koehler, P. (2009) Eur. Food Res. Technol. 229,
9–13
(17) DuPont, F.M., Chan, R., Lopez, R., & Vensel, W.H. (2005) J.
Agric. Food Chem. 53, 1575–1584.
jf048697l
(18) Hurkman, W.J., & Tanaka, C.K. (2007) J. Chromatogr. B:
Anal. Technol. Biomed. Life Sci. 849 , 344–350
org/10.1016/j.jchromb.2006.11.047
(19) van Eckert, R., Berghofer, E., Ciclitira, P.J., Chirdo, F., Denery-
Papini, S., Ellis, H.J., Ferranti, P., Goodwin, P., Immer, U.,
Mamone, G., Méndez, E., Mothes, T., Novalin, S., Osman, A.,
Rumbo, M., Stern, M., Thorell, L., Whim, A., & Wieser, H.
(2006) J. Cereal. Sci. 43, 331–341
jcs.2005.12.009
(20) ISO 11843-2 (2000) Capability of Detection, Part 2:
Methodology in the Linear Calibration Case, International
Organization for Standardization, Geneva, Switzerland
(21) ISO 11843-5 (2008) Capability of Detection, Part 5:
Methodology in the Linear and Non-Linear Calibration Cases,
International Organization for Standardization, Geneva,
Switzerland
(22) ISO 5725-2 (1994) Accuracy (Trueness and Precision) of
Measurement Methods and Results, Part 2: Basic Method for
the Determination of Repeatability and Reproducibility of a
Standard Measurement Method, International Organization for
Standardization, Geneva, Switzerland
(23) ISO 21415-1 (2007) Wheat and Wheat Flour-Gluten Content-