APAC SPSFAM Mid Year 2016

AOAC SPSFAM ALLERGENS DRAFT SMPR ‐ COMMENTS on ALLERGENS SMPR FINAL

Line  Numbers (If  Applicable)

Item

Comment

Proposed Change(s)

Response

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.

139 (table  2)

1

Chocolate is an important matrix for peanut, hazelnut and milk.

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 

2 56‐65

Should the precision data obtained over the whole analytical range? Number of levels?

No change recommended.    The comment is true but there is  not any prohibition against the LOQ = MDL.

116 (table  1)

3

By definition the analytical range can only start with an LoQ. MDL only gives a yes or no.

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!)

No change.   The working group did not agree to tie LC‐MS/MS  results to ELISA results.

Discuss traceability and comparability to ELISA results (note: this SMPR  discuss a possible reference method for cGMP compliance!)

4

Discuss suitability of this SRM in the working group and give conversion  factor

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.

No change.  That’s will be left up to the methode developer.

5 96

Agree. Replace NIST SRM 1549 wuth 1549a.

6 92

NIST SRM 1549 is superseded by NIST 1549a

Delete NIST SRM 1549

Working Group agreed that all results to be "reported as ppm  of the target allergen in food commodity".

Discuss traceability in the working group and discuss a conversion  factor

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?

7 85

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.

We should follow the guideline for ELISA which prefer incurred

8 67

Recovery: What kind of samples is required? Spiked or incurred? For ELISA incurred is preferred.

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?

No change recommended.    Method development issue not  SMPR issue. 

Discuss in the working group and remember to solve the traceability  problem

9 67

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.

10 62