AOAC GFA Stakeholder Program Meeting Book (August 27, 2023)

PAGE NINE – 4.6 ACCEPTANCE CRITERIA FOR SELECTIVITY AND MATRIX STUDIES - LOQ

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.

Delete "for a particular food allergen", as the document deals with gluten.

Made with FlippingBook Online newsletter creator