AOAC SPSFAM ERP for SELECTED FOOD ALLERGENS

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. 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. 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 III.

Yes

Again: the calculation of MDL and MQL is not correct. The calculation should not use a commercial software for the estimation of S/N ratio and consequently final sensitivity of the method. Such approach is not correct and would never apply to other instruments since it is instrument and brand specific. Please carefully check the proper Anal chem guidance for the correct estimation of MDL and MQL. This value should be recalculated and also the recovery according to what stated in the SMPR guidelines (n of independent analyses for each concentration level).

General Submission Package

no