AOAC Guidance on FA Immunoassay Validation (August 2023)

4.4.1. Method developers must provide complete information on the allergen materials and procedures used to prepare in house test materials to the ERP or volunteer expert. If detailed preparation techniques are perceived to be proprietary information, requests may be made for the ERP/volunteer expert for these data to remain confidential. Method developers must, however, provide information sufficient for end users to understand the allergen materials, test material composition (i.e., matrix formulation), and test material processing conditions in method 247 4.4.2. Specific guidance on allergen materials and test material preparation can be found in Annex A. 248 4.5. Antibody description 249 4.5.1. Method developers must provide information on the antibody/antibodies used. As much 250 information on antibody development and specificity as possible is strongly encouraged. 251 4.5.2. Information on the antibody must include the following: 252 4.5.2.1. Whether the antibody is monoclonal or polyclonal 253 4.5.2.2. What protein(s) does the antibody detect? Method developers must either provide 254 empirical confirmation of specificity (e.g., Western blot) or information on protein(s) used 255 for antibody development. 256 5. Quantitative Method Validation 257 5.1. General Study Practices 258 5.1.1. Method developers may prepare study test materials in house for the single laboratory validation 259 (method developer study), but all samples and test portions must be blind-coded and 260 randomized. Analysis conducted by the method developer must be performed by an independent 261 analyst without prior knowledge of the test materials undergoing analysis in a given sample set. 262 5.1.2. Ideally, all test materials for the independent laboratory and collaborative study should be prepared 263 by an external entity independent from the method developer. At least one incurred test material for 264 the independent laboratory and collaborative study must be prepared by an external entity independent 265 from the method developer. In situations where an independent entity is unavailable to prepare all 266 of the test materials for the independent laboratory and collaborative study, or their use is 267 impractical for all test materials, method developers may produce and distribute test materials as 268 long as detailed information is provided on procedures used to prevent bias (preparation, coding, 269 etc.), and justification is provided for failing to use an independent entity to prepare all of the test 270 materials. 271 5.2. Single Laboratory Validation Study (Method Developer Study) 272 5.2.1. Scope 273 A Single Laboratory Validation (SLV) study, also referred to as the Method Developer Study for the 274 purposes of the PTM program, is intended to evaluate the performance of a candidate method in the 275 following areas: (1) selectivity, (2) precision (repeatability and intermediate precision), (3) sensitivity, (4) 276 recovery, and (6) robustness. These studies are generally conducted within a method developer 277 laboratory. 278 5.2.2. Calibration Fit Study 279 5.2.2.1. Analyze calibration standards as they are included in the test kit. 280 241 242 243 244 245 246 validation reports.