ISPAM Stakeholder Panel Meeting Book 3-14-17

Section: Table 1: Analytical Range

Table 1. Analytical range should be more in the range of 5 ppm whole egg protein for most products (with special requirements as needed for other matrices such as wine). Most kits on the market now have an LOQ below 1 ppm egg protein, and this range would be more in scale with the VITAL reference dose/action level system. Do we want to provide conversions here to whole liquid egg, liquid egg whites or egg white protein (e.g. For the top end of the analytical range, it might be more clear to state something like, "at least ten times the LOQ", rather than just ">10", which could lead to somewhat narrow analytical ranges (e.g. 3-13 ppm whole dried egg). Table 1: Analytical Range: 0.5-500 ppm; LOQ: 0.5 ppm; LOD: 0.1 ppm; Recovery: 60-140%; Small r RSD: 15% ALSO these values should be adjusted to the food matrices that are being considered and should be adjusted for typical serving sizes. (Multiple tables may be necessary especially with the inclusion of environmental samples)

Analytical range was set based on practical application of egg testing System suitability mandated the provision of all the required information related to correlation between reported levels and egg proteins

Laura Allred, GFCO/GIG

79

126

Melanie Downs. Univ of Neb

The minimum requirement as set allow for a flexible analytical range.

80

Minimum requirements set for these parameters satisfy egg testing needs. SMPR has been amended to require the kit manufacturer to clearly state the intended use and claimed matrices.

Michael Farrow, Abbott

81

Section: Table 1: Specificity / Crossreactivity

system suitability section 6, now requires to list cross reactivity of the assay as per Appendix M recommendations system suitability section 6, now requires to list cross reactivity of the assay as per Appendix M recommendations

Virginie Barrere, Université Laval

If specifity is added, should cross reactivity be tested as well and a list of food matrices be added for this purpose?

82

Michael Farrow, Abbott

Where would information on Cross-Reactivity be captured?

83

Table 2: Chicken is a possible cross-reacting commodity that needs to be characterized (see also AOAC Guidelines by Abbott et al.). To be discussed in the group if the list stated in the Abbott paper is sufficient. Add specificity/cross reactivity as a method performance requirement. The ELISA kit should report that versus Table 1 or a more relevant subset thereof for egg. Appendix M indicates to test based on full-strength extracts.

Current requirements are minimum requirements and could be expanded upon

126 Markus Lacorn, R- Biopharm

84

system suitability section 6, now requires to list cross reactivity of the assay as per Appendix M recommendations

85

126 Diana Kavolais, Hershey

Definition – Specificity: need to connected to the binding technology that implied by the ELISA definition.

Captured in amendments to system suitability section 6 per Appendix M system suitability section 6, now requires to list cross reactivity of the assay as per Appendix M recommendations

86

27 Yumin Chen, PepsiCo

Lisa Monteroso (3M)

87

Add a table 3 for cross-reactivity test materials.

Per discussion of including cross-reactivity in the SMPR. Appendix M does discuss this. Perhaps good language in the SMPR would be such like - "Cross-reactivity has been investigated as per Appendix M. Method developers should submit cross-reactivity data and include any notable observations." or something like that.

System suitability section 6, now requires to list cross reactivity of the assay as per Appendix M recommendations

Paul Wehling General Mills, Inc.

88

Section: Table 2: Matrices

Matrices listed in table 2 are examples of recommended matrices for egg testing as per guidance from Appendix M (kit manufacturers can select amongst these matrices or beyond as needed) Matrices listed in table 2 are examples of recommended matrices for egg testing as per guidance from Appendix M (kit manufacturers can select amongst these matrices or beyond as needed)

Yasutaka Nishiyama, NH Foods Ltd.

131

89

These matirices are acceptable to be included in the table.

Delete Table 2 and include examples in Table 1 as described in another comment

131 Markus Lacorn, R- Biopharm

90

Can we combine some of M table 2 into categories as well as add new categories? 1) Raw and Cooked Baked Goods - (dough, bread, cookies), 2) Raw and cooked Meat - chicken, sausage. 3) Pasta - dry and fresh (refrigerated). 4) Confectionery - Dark Chocolate Ovomaltine (high tannin) - an ingredient used in confections, cookies, beverages - used worldwide - and formulations may or may not contain egg, nougat, marizpan. marshmellow), Ice Cream, 5) Fluids - Salad dressing, Milk beverages (soy). Expanding to include matrices that answer to Appendix M's statement on factors that influence test results (1) interactions with compounds in food (polyphenols and tannins). Raw and cooked - address

Matrices listed in table 2 are examples of recommended matrices for egg testing as per guidance from Appendix M (kit manufacturers can select amongst these matrices or beyond as needed)

91

131 Diana Kavolais, Hershey

System suitability section 6, now requires to list cross reactivity of the assay and information on matrices (difficulties encountered) as per Appendix M recommendations

Diana Kavolais, Hershey

92

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