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: