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A review of guidelines for evaluating a minor modification to a validated assay
2021
Rev Sci Tech Off Int Epizoot
Preserved Fulltext
Any modification to a validated assay must be evaluated in terms of the impact on the assay's performance characteristics and whether the assay remains fit for the intended purpose. The comparison is referred to as a 'method comparison', 'method comparability', 'method change', or 'comparative validation'. This review presents recommendations and examples of studies found in the current literature as a means of assessing minor modifications. In addition, the authors discuss common statistical approaches used for these comparisons.
doi:10.20506/rst.40.1.3219
pmid:34140729
fatcat:6vxppzr2qfep3av6h3tyr5x5iu