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Item
Line
Numbers (If
Applicable)
Comment
Proposed Change(s)
Response
1
139 (table
2)
Chocolate is an important matrix for peanut, hazelnut and milk.
Chocolate should be included into the list of priority allergens. If
chocolate is a known problem than the applicability should clearly
state that chocolate is not possible to measure using the validated
method.
No change.
Chocolate is an optional matrix to be tested for
candidate method that claim to work in chocolate.
2 56‐65
Should the precision data obtained over the whole analytical range? Number of levels?
Describe the validation of precision in a more precise way e.g. include
number of levels and replicates
Additional reference
to Appendix D and F are added
3
116 (table
1)
By definition the analytical range can only start with an LoQ. MDL only gives a yes or no.
No change recommended.
The comment is true but there is
not any prohibition against the LOQ = MDL.
4
After validation, LC‐MS/MS methods will be used for comparison with ELISA results. An commercial
ELISA is (often) calibrated to the whole allergenic food while LC‐MS/MS is calibrated to peptides. Is
comparability established via reference materials? (again: traceability of LC‐MS/MS to these RMs is
mandatory!)
Discuss traceability and comparability to ELISA results (note: this SMPR
discuss a possible reference method for cGMP compliance!)
No change.
The working group did not agree to tie LC‐MS/MS
results to ELISA results.
5 96
NIST SRM 2387 is not pure peanut but a mixture of roasted peanut, sugar, partially hydrogenated
vegetables oils and salt. See NIST certificate: protein content is given but not peanut content.
Discuss suitability of this SRM in the working group and give conversion
factor
No change.
That’s will be left up to the methode developer.
6 92
NIST SRM 1549 is superseded by NIST 1549a
Delete NIST SRM 1549
Agree. Replace NIST SRM 1549 wuth 1549a.
7 85
NIST 8445 is a whole egg powder with a given protein content. How should a method developer
trace it to whole egg without conversion factor?
Discuss traceability in the working group and discuss a conversion
factor
Working Group agreed that all results to be "reported as ppm
of the target allergen in food commodity".
8 67
Recovery: What kind of samples is required? Spiked or incurred? For ELISA incurred is preferred.
We should follow the guideline for ELISA which prefer incurred
Add a reference to Appendix M: Validation Procedures for
Quantitative Food Allergen ELISA Methods.
Appendix M does
mandate the use of incurred samples. AOAC policy allows for
both kinds of samples. Method developer discretion.
9 67
Recovery: How should a method developer determine this parameter? By spiking with reference
materials or peptides or a different material. One should remember that it is not allowed to use a
reference material for calibration AND spiking! If peptides are used for calibration, how was
traceability established?
Discuss in the working group and remember to solve the traceability
problem
No change recommended.
Method development issue not
SMPR issue.
10 62
Since reproducibility determination is only possible by a collaborative study, an intra‐laboratory
reproducibility should be defined to ease single‐lab validations at the beginning
Inlcude a new clause after repeatability and describe the validation to
be done
No change.
All previous SMPRs used RSDR and RSDr.
AOAC SPSFAM ALLERGENS DRAFT SMPR ‐ COMMENTS on ALLERGENS SMPR FINAL