Examples of Types of PTM Modification Validations
Table 1. Level 2 Method Modification Examples and Data Requirements Method Modification Data Requirement
Matrix extensions up to four matrices, depending on the number of matrices included in the original validation claim. For example: Original claim 4 – level 2 modification would be acceptable for only one matrix. More than five claimed matrices require an independent lab study. Original claim 6 – level 2 modification for the addition of 4 more matrices is acceptable without an independent study. Changes to non‐critical reagents (lyophilization, Taq,), does not include reagents that may affect specificity/sensitivity such as new antibodies or primer/probe sequences. Enhancement of method workflow (non‐ critical steps) Non‐reagent changes, such as changes to the cartridge or increase in number of wells Changes in matrix sample sizes
Matrix comparison study for all matrices.
Matrix comparison study for all matrices and samples sizes with the reference method samples size.
Inclusivity/exclusivity and matrix comparison data for a subset of claimed matrices. In some instances lot‐to‐lot, stability and robustness required.
Testing of 3 matrices inoculated post enrichment; inclusivity/exclusivity; lot‐to‐lot studies.
Dilution to extinction experiment. Matrix study 1‐3 matrices tested depending upon the overall matrix claim for the method (matrices chosen by AOAC). Inclusivity/exclusivity and matrix comparison data for a subset of claimed matrices (matrices chosen by AOAC). Where possible, the testing of frozen lysates from previous validation on new instrument. Inclusivity/exclusivity and matrix comparison data for a subset of claimed matrices.
New instrument, thermal cycler, PCR platform or other
Addition of DNA preparation methods
Addition or update reference method
Matrix comparison study for a subset of matrices.
Expansion of the inclusivity claim within the same target analyte species; for example, in the case of expansion of Listeria species claim. Expansion of stability claim for reagents/
Inclusivity and exclusivity testing (blind‐randomized).
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