Methods comparison: An alternative approach for evaluating the impact of a modification to a validated assay

Monica M. Reising, Kate R. Schumann, Beate Crossley, Patricia S. Glas, Richard H. Jacobson, Kathy L. Kurth, Janice C. Pedersen, David Siev, Barbara M. Martin

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

The current report discusses the process in which a methods comparison study in the National Animal Health Laboratory Network is performed. Specific details are provided for designing and analyzing studies intended to evaluate analytical sensitivity, efficiency, analytical specificity, cross-contamination, repeatability, operator variability, and to compare the performance of methods using diagnostic samples. As an example, a case study is presented comparing the performance of a candidate reverse transcription polymerase chain reaction (RT-PCR) chemistry to the current RT-PCR chemistry in use when the assay was originally validated. The present study revealed that, for all of the validation factors evaluated, the candidate method performed at least as well and generally better than the current method. The candidate method was, therefore, deemed fit for the original intended purpose of the current method and rendered acceptable for use. A discussion of the case study is intended to further motivate consideration of the study designs chosen.

Original languageEnglish (US)
Pages (from-to)480-487
Number of pages8
JournalJournal of Veterinary Diagnostic Investigation
Volume26
Issue number4
DOIs
StatePublished - 2014

Keywords

  • Methods comparison
  • polymerase chain reaction
  • validation

ASJC Scopus subject areas

  • veterinary(all)

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