AOAC Guidance on FA Immunoassay Validation (August 2023)

784 785 786

5.4.6.2.1.4.2. LOQ 30 , for a method where the LOQ was set based on the collaborative

study outcome and a maximum RSD R of 30%

6. Qualitative Method Validation 6.1. General Study Practices

787 6.1.1. Method developers may prepare study test materials in house for the single laboratory validation 788 (method developer study), but all samples and test portions must be blind-coded and 789 randomized. 790 6.1.2. Analysis conducted by the method developer must be performed by an independent analyst 791 without prior knowledge of the test materials undergoing analysis in a given sample set. 792 6.1.3. Ideally, all test materials for the independent laboratory and collaborative study should be 793 prepared by an external entity independent from the method developer. At least one incurred 794 test material for the independent laboratory and collaborative studies must be prepared by an 795 external entity independent from the method developer. In situations where an independent 796 entity is unavailable to prepare all of the test materials for the independent laboratory and 797 collaborative studies, or their use is impractical for all test materials, method developers may 798 produce and distribute test materials if detailed information is provided on procedures used to 799 prevent bias (preparation, coding, etc.), and justification is provided for failing to use an 800 independent entity to prepare all of the test materials. 801 6.1.4. Method developers should consult AOAC Appendix N for explanations of general principles of 802 qualitative method validation. (13) 803 6.2. Single Laboratory Validation (Method Developer Study) 804 6.2.1. Scope 805 A Single Laboratory Validation (SLV) study, also referred to as the Method Developer Study for the 806 purposes of the PTM program, is intended to evaluate the performance of a candidate method in the 807 following areas: (1) selectivity, (2) sensitivity, and (3) robustness. These studies are generally conducted 808 within a method developer laboratory. 809 6.2.2. Selectivity Study 810 The selectivity study is intended to provide information on potential sources of cross-reactivity and 811 interference. The information related to cross-reactivity and interference should be reported in the 812 validation report or in the package insert from the method developer. 813 6.2.2.1. Selectivity Panel Selection 814 6.2.2.1.1. Method developers must test their allergen detection method for cross-reactivity for 815 the target allergen in a variety of food commodities. Food commodities tested for 816 cross-reactivity should include a wide selection of foods and ingredients, particularly 817 those that are genetically similar to the target allergenic commodity and that are 818 likely to be analyzed for the presence of the target food allergen. (9) 819 6.2.2.1.2. For all food allergen analytes, all foods in Table 2 must be analyzed. For specific food 820 allergen analytes, additional matrices listed in Table 3 must be analyzed. Additional 821 foods and ingredients listed in Table 4 may be included in the study. 822