A review of guidelines for evaluating a minor modification to a validated assay

M. M. Reising, C. Tong, B. Harris, K. L. Toohey-Kurth, B. Crossley, D. Mulrooney, R. L. Tallmadge, K. R. Schumann, A. B. Lock, C. M. Loiacono

Research output: Contribution to journalReview articlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)217-226
Number of pages10
JournalRevue scientifique et technique (International Office of Epizootics)
Volume40
Issue number1
DOIs
StatePublished - Jun 1 2021

Keywords

  • Assessing agreement
  • Comparative validation
  • Equivalence
  • Guidelines
  • Method change
  • Method comparability
  • Method comparison
  • Reagent replacement

ASJC Scopus subject areas

  • Medicine(all)

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