RI-ERP-FINALACTION-Recommendations

OMAMAN-20 C/ In House Validation Report ERP Use Only - March 2015

6 Conclusion In summary, the data of the in-house validation study prove that the performance claims are fulfilled. The high sensitivity of the assay and the small range of concentrations between negative and positive results made the calculation of POD50 or POD95 values according to the AOAC Appendix N in nearly all cases impossible. Nevertheless, the claimed detection limits of 2.5 mg gliadin/kg (ethanol extraction), 4 mg gliadin/kg (Cocktail extraction) and 1 – 2 µg gliadin / 100 cm 2 were confirmed or even slightly higher sensitivities were observed. Together with the information obtained by the collaborative test (under AACC supervision) and the in-house validation data, the RIDA®QUICK Gliadin should be recommended as Official Methods of Analysis SM First Action of AOAC INTERNATIONAL. (1) AOAC International. Appendix N: ISPAM Guidelines for validation of qualitative binary chemistry methods. AOAC Official Methods of Analysis . Gaithersburg. MD, 2013. (2) 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. (3) Van Eckert, R., Berghofer, E., Ciclitira, P. J., Chrido, 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. and Wieser, H. (2006) Towards a new gliadin reference material – isolation and characterization. J. Cereal Sci. 43:331-341 (4) 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 ELISAmethods: AOAC allergen community guidance and best practices. J. AOAC Internat. 96:1033, 2013. (5) Koehler, P., Schwalb, T., Immer, U., Lacorn, M., Wehling, P., and Don, C. AACCI Approved Methods Technical Committee report: Collaborative study on the immunochemical determination of intact gluten using an R5 sandwich ELISA. Cereal Foods World 58:36, 2013. Acknowledgements We would like to thank Lukas Kraft and Sabine Zeidler for their great practical help during the in-house validation study, Katharina Scherf (nee Konitzer) and Peter Köhler 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. 8 7 References

AOAC Research Institute Expert Review Panel Use Only

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RIDA®QUICK Gliadin Validation report 2015-01-14