SPSFAM Allergens ERP

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. 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. 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. 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? 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. 3. Is there information demonstrating that the

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.

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 inadequate.In 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.

No. See previous answer regarding the ability to evaluate the reported method performance values, given the lack of methodological information and actual data.

No

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.