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1. Are the definitions
specified in the SMPR used
and applied appropriately in
the supporting
documentation (manuscripts,
method studies, etc...)? If not,
please explain the differences
and if the method is impacted
by the difference.
Based on the presentation of information in the submission, it is tremendously unclear
whether the authors are applying the definitions of “food allergens” from the SMPR
appropriately throughout the document. All indications of concentrations of food
allergens must have absolutely clear units applied. For example, several different milk-
based ingredients are used in the method and supporting data. The use of “50 ppm
milk” is insufficient and should be revised to indicate precisely what the authors mean.
Does it mean 50 ppm fluid whole milk in a specific matrix/solution or 50 ppm lyophilized
whole milk in a specific matrix/solution or 50 ppm nonfat dry milk in a specific matrix?
The absence of clarity on these definitions of units makes it impossible to determine
whether the method meets the requirements from the SMPR based on the data
presented. The differences between fluid whole milk (the SMPR definition of “milk”),
lyophilized whole milk, and nonfat dry milk make a highly significant impact on
determining limits of detection and quantification.
2. Is there information
demonstrating that the
method meets the SMPR
Method Performance
Requirements using the
Reference Materials stated in
the SMPR? If not, then
specify what is missing and
how this impacts
demonstration of
performance of the method.
The authors used alternative sources of reference materials to evaluate the method
performance, as there are few certified reference materials for food allergens. Instead
of the actual materials being the primary issue, this section is yet again woefully lacking
in concise, accurate information about the correct units for these reference materials
and what units the authors are implementing for their own results. For example, the
authors indicate that they utilized iFAAM peanut reference materials that contained 40
ppm peanut, but this is incorrect. The iFAAM reference material contains 40 ppm
peanut protein in reconstituted dessert matrix. The descriptions of the other reference
materials are similarly unclear or incorrect. Throughout this section of data, the authors
then apply mystery correction factors, which are not sufficiently justified or explained,
particularly given the misstatement of concentrations for some of the reference
materials. The authors indicate that some of these correction factors are calculated
based on Bradford assay protein determinations, but no information is given regarding
how or when said protein determinations were performed. Also, the applicability of
soluble protein concentrations as opposed to total protein concentrations (i.e. as
determined by Kjeldahl or Duma methods) for these materials must be clearly justified.
3. Is there information
demonstrating that the
method performs within the
SMPR Method Performance
REquirements table
specifications for all analytes
in the SMPR applicability
statement? If not, please
specify what is missing and
whether or not the method's
applicability should be
modified.
As noted above, the unclear presentation of information and particularly measurement
units in the submission makes this reviewer unable to determine whether the method
meets any of the SMPR specifications.
1. Based on the supporting
information, were there any
additional steps in the
evaluation of the method that
indicated the need for any
additional precautionary
statements in the method?
No.
2. Does the method contain
system suitability tests or
controls as specified by the
SMPR? If not, please indicate
if there is a need for such
tests or controls and which
ones.
The authors did not specifically indicate system suitability tests were performed.