AOAC Gluten Quantitative Validation Guidance-Round 1(Nov 2023)

Added an example sentence that reads “This means that, at a minimum, single gluten source/concentration test materials, at five different concentrations, could be tested across five different matrices. The use of more than 5 materials is recommended. “ Page 12, Section 6.6 : Delete "for a particular food allergen", as the document deals with gluten Removed Page 12, Section 6.6, LOQ : Change "SLV" to "collab study" or delete the whole paragraph if inserted by mistake. Changed, the sentence now reads “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 Collaborative Study (which meets the SMPR requirements for maximum RSD R ) must be less than or equal to the claimed LOQ of the kit, within statistical tolerances. If the estimated LOQ from the Collaborative Study 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.” Page 12, Matrix Extension : Change the number from 6 to 7; 6 is the collab study Page 12, Matrix Extension : Renumber Matrix Extension section (Currently listed as 6, sub-sections are 7.x) Fixed Page 12, Sections 7.1 and 7.2 : Delete "POD" several times. Removed Page 12, Sections 7.1 and 7.2 : Would like clarification on if matrix extension is performed, do they “pick up where they left off” on table 4.4? or required to start at column 1? Yes, and this has now been edited to read “ 7.1 Matrix Extension for single lab validation studies A single lab matrix study must be performed as described in 4.4, picking up where the laboratory left off in the gluten source tables (1 and 2). A matrix study must also be completed by an independent laboratory, and reported, as described under 5.2 . 7.2 Matrix Extension for multi-site collaborative studies A single lab matrix study must be performed as described in 4.4, picking up where the laboratory left off in the gluten source tables (1 and 2). A minimum of eight collaborator sites will perform the matrix studies as described under 6.3 and reported as described under 6.5 . “ ANNEX A Table 1 : Change "two times the CDC" to "three times the LOQ", to stay consistent with the main document #4.3. Edited ANNEX B : The use of the "wet chemical method" to determine the gluten content of wheat, barley and rye is not commercially available (at least so far). This fact could lead to frustration to method developers searching labs that provide this method.