AOAC GFA Stakeholder Program Meeting Book (August 27, 2023)
LOQ The RSD i at the LOQ must be less than or equal to the RSD i in the relevant SMPR (or the RSD R if an RSD i is not listed). If there is no SMPR available for a particular food allergen, RSD i at the LOQ must be ≤ 30%. If a method developer has an LOQ claimed as part of the method design (e.g., the lowest non-zero calibrant), the estimated LOQ from the SLV (which meets the SMPR requirements for maximum RSD i ) must be less than or equal to the claimed LOQ of the kit, within statistical tolerances. If the estimated LOQ from the SLV is greater than the claimed LOQ of the kit, the method developer must revise the LOQ claimed in the test kit insert and validation reports to meet the precision requirements for LOQ. In the validation reports and test kit inserts, the method developers must indicate the actual RSD i value estimated for the LOQ of the kit as part of the LOQ information. For example: LOQ 15 , for a method where the existing LOQ claimed by the kit had an estimated RSD i of 15% in the SLV LOQ 30 , for a method where the LOQ was set based on the SLV outcome and a maximum RSD i of 30%Acceptance criteria for the maximum RSD also includes meeting requirements for confidence intervals, as established by the AOAC Statistics Committee. The LOQ estimate must be greater than or equal to the LOD estimate. If the LOQ estimate is lower than the LOD estimate, the LOQ should be reported as the same concentration as the LOD. PAGE NINE – 4.6 ACCEPTANCE CRITERIA FOR SELECTIVITY AND MATRIX STUDIES - LOQ
Delete "for a particular food allergen", as the document deals with gluten.
LOQ, 5 th paragraph: Period and space after maximum RSDi of 30%.
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