AOAC ERP Gluten Assays - Dec 2018

Annex B

(3) Codex Alimentarius Commission. Codex Standard 118-1979 (rev. 2008), Foods for special dietary use for persons intolerant to gluten. Codex Alimentarius. FAO/WHO, Rome, 2008.

(4)

Wieser, H. & Koehler, P. (2009 ) Eur. Food Res. Technol. 229 , 9-13

(5) Wild D (2013) The Immunoassay Handbook - Theory and Applications of Ligand Binding, ELISA and Related Technique, Elsevier Science, Amsterdam, Netherlands, 4th Edition, p. 327. (6) AOAC International. Appendix M: Validation Procedures for Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices. AOAC Official Methods of Analysis. Gaithersburg. MD, 2012.

(7) CLSI EP25-A (2009), Evaluation of stability of In-Vitro Diagnostic Reagents, Approved Guideline

(8) Weiss, T., Lacorn, M., Flannery, J., Benzinger, M.J., Bird, P., Crowley, E.S., Goins, D., Agin, J., Gilani, S., Poepping, B., & Garber, E. (2016) J. AOAC. Int. 99 , 495-503

(9) Valdes, I., Garcia, E., Llorente, M., & Mendez, E. (2003) Eur. J. Gastroenterol. 15 , 465- 474

(10) Tye-Din, J., Stewart, J., Dromey, J., Beissbarth, T., van Heel, D., Tatham, A., Henderson, K., Mannering, S., Gianfrani, C., Jewell, D., Hill, A., McCluskey, J., Rossjohn, J. & Anderson, R. (2013) Sci. Transl. Med. 2 , 41-51

(11) Lexhaller, B., Tompos, C., & Scherf, K.A. (2016) Anal. Bioanal. Chem . 408 , 6093-6104

(12) Kahlenberg, F., Sanchez, D., Lachmann, I., Tuckova, L., Tlaskalova, H., Méndez, E. & Mothes, T. (2006) Eur. Food Res. Technol. 222 , 78-82

(13) Wieser, H., Koehler, P., & Konitzer, K. (2014) Celiac Disease and Gluten, Elsevier Inc., London, UK, ISBN 978-0-12-420220-7, p. 107.

(14) Koerner, T., Abbott, M., Godefroy, S.B., Popping, B., Yeung, J.M., Diaz-Amigo, C., Roberts, J., Taylor, S.L., Baumert, J.L., Ulberth, F., Wehling, P., and Koehler, P. Validation procedures for quantitative gluten ELISA methods: AOAC allergen community guidance and best practices. J. AOAC Internat . 96 :1033, 2013.

(15) Koehler, P., Schwalb, T., Immer, U., Lacorn, M., Wehling, P., & Don, C. (2013) Cereal Foods World 58 , 36-40

7 Acknowledgements We would like to thank Nathalie Widmann, Niklas Weber and Lukas Kraft for their great practical help during the in-house validation study, Katharina Scherf for the delivery of different flours and valuable discussions. Last but not least we would like to thank Patricia Meinhardt for proof-reading and all her practical experiences.

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RIDASCREEN ® Total Gluten In-house validation report 2018-10-21