Gluten in Oats Working Group Meeting Book (March 12, 2019)
6. System Suitability 63 See information on antibodies, cross reactivity, and calibrators in Appendix M.
64 65
7. Reference Material(s) 66 Samples of oat flour spiked with wheat, rye, and barley for validation studies are available from U.S. 67 Pharmacopeia, Rockville, MD, USA. 68 69 Refer to Annex F: Development and Use of In‐House Reference Materials in Appendix F: Guidelines for 70 Standard Method Performance Requirements, Official Methods of Analysis of AOAC INTERNATIONAL 71 (2019) 21st Ed., AOAC INTERNATIONAL, Rockville, MD, USA ( http://www.eoma.aoac.org/app_f.pdf ) 75 1) Provide antibody information, cross reactivity data, and information on calibrators according to 76 Appendix M 77 2) Wherever possible, identify peptide sequences or target epitopes for all antibodies used 78 3) Determine and submit estimates for recovery for each gluten source (wheat, rye, and barley) using 79 the oat flour testing materials (see Reference Material(s) section for source information) 82 1) A sample processing procedure for homogenization, particle size reduction, and test portion size 83 2) Data and estimates for LOD and LOQ 84 3) Precision estimates (RSDr and/or RSDR) 85 86 Method developers may use spiked samples to determine the recovery performance of candidate 87 methods for specific claimed matrices. Guidance on spiking for recovery evaluation are provided at: 88 (1) Koerner et al. (2013) J. AOAC Int. 96(5), 1033. doi.org/10.5740/jaoacint.13‐043 89 (2) Estimating Recovery of a Gluten ELISA Kit Method, J. AOAC Int. (future issue) 90 (3) Appendix D: Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of 91 Analysis, Official Methods of Analysis of AOAC INTERNATIONAL (2019) 21st Ed., AOAC INTERNATIONAL, 92 Rockville, MD, USA (http://www.eoma.aoac.org/app_d.pdf) 93 72 73 74 8. Validation Guidance For all candidate methods, developers must: 80 81 For all claimed matrices, developers must submit:
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