SPSFAM Allergens ERP

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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.
No. See previous comments regarding unclear use of definitions and reporting units.
Absolutely clear and correct units must be used in order to determine whether the
method meets any of the performance requirements.
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 present almost no actual data to support the claims they make with
respect to the method performance. The authors fail to even present basic information
about how the method performance studies were conducted. They give no information
about how the food matrices used for performance evaluation were formulated or
prepared, no information about what allergenic food materials were used in those
matrices, and no information about how the spiked (or incurred) foods were prepared.
The authors also present no information regarding how they arrived at their quantitative
values from the data that would have been generated from the method. Given this
tremendous lack of information about how the studies were conducted, the tables
provided by the authors as attempts to verify the performance characteristics of the
method are addition, as was noted in previous answers, the lack of
clarity on reporting units makes it difficult, if not impossible, for this reviewer to evaluate
the supposed method performance.
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.
No. See previous answer regarding the ability to evaluate the reported method
performance values, given the lack of methodological information and actual data.
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 descriptions of system suitability tests are inadequate. From what little can be
interpreted, the methods may have major issues with correct definitions and
measurement units to align with the SMPR.