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79
Laura Allred,
GFCO/GIG
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.
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
80
Melanie Downs.
Univ of Neb
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).
The minimum requirement as set allow for a flexible
analytical range.
81
Michael Farrow,
Abbott
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)
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.
82
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?
system suitability section 6, now requires to list cross
reactivity of the assay as per Appendix M
recommendations
83
Michael Farrow,
Abbott
Where would information on Cross-Reactivity be captured?
system suitability section 6, now requires to list cross
reactivity of the assay as per Appendix M
recommendations
84
126 Markus Lacorn, R-
Biopharm
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.
Current requirements are minimum requirements and
could be expanded upon
85
126 Diana Kavolais,
Hershey
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.
system suitability section 6, now requires to list cross
reactivity of the assay as per Appendix M
recommendations
86
27 Yumin Chen,
PepsiCo
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
87
Lisa Monteroso
(3M)
Add a table 3 for cross-reactivity test materials.
system suitability section 6, now requires to list cross
reactivity of the assay as per Appendix M
recommendations
88
Paul Wehling
General Mills, Inc.
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
89
131
Yasutaka
Nishiyama, NH
Foods Ltd.
These matirices are acceptable to be included in the table.
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)
90
131 Markus Lacorn, R-
Biopharm
Delete Table 2 and include examples in Table 1 as described in
another comment
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
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).
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)
92
Diana Kavolais,
Hershey
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
System suitability section 6, now requires to list cross
reactivity of the assay and information on matrices
(difficulties encountered) as per Appendix M
recommendations
126
Section: Table 1: Specificity / Crossreactivity
Section: Table 2: Matrices
Section: Table 1: Analytical Range