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ARS Home » Northeast Area » Frederick, Maryland » Foreign Disease-Weed Science Research » Research » Publications at this Location » Publication #354656
Research Project: Biology, Epidemiology, and Detection of Emerging Plant Pathogenic Oomycetes

Location: Foreign Disease-Weed Science Research

Title: Principles of diagnostic assay validation for plant pathogens

Author
item CARDWELL, KITTY - Oklahoma State University
item SHIEL, PAT - Animal And Plant Health Inspection Service (APHIS)
item NAKHLA, MARK - Animal And Plant Health Inspection Service (APHIS)
item FLETCHER, JACQUELINE - Oklahoma State University
item Luster, Douglas - Doug
item STACK, JAMES - Kansas State University
item DENNIS, GEOFFREY - Animal And Plant Health Inspection Service (APHIS)
item RICE, ANNA - Envirologix
item WALSH, COILIN - Agdia
item FLANNERY, ANDREW - Pathsensors, Inc

Submitted to: Plant Health Progress
Publication Type: Review Article
Publication Acceptance Date: 8/13/2018
Publication Date: 10/12/2018
Citation: Cardwell, K., Shiel, P., Nakhla, M., Fletcher, J., Luster, D.G., Stack, J., Dennis, G., Rice, A., Walsh, C., Flannery, A. 2018. Principles Of diagnostic assay validation for plant pathogens. Plant Health Progress. 19:272-278. https://doi.org/10.1094/PHP-06-18-0036-RV.
DOI: https://doi.org/10.1094/PHP-06-18-0036-RV

Interpretive Summary: A one-day workshop entitled ‘Principles of Validation for Plant Pathogen Diagnostic Assays’ was held August 5th, 2017,,in San Antonio, TX, organized by the authors of this report, and attended by 65 participants across a spectrum of academic, federal/state government and industry, researchers and students. This manuscript is a summary of the content of that workshop and is presented to further discussion on the science and practice of diagnostic assay validation, upon which are based the assays so critical to protecting plant health and safeguarding trade. The objectives of the workshop were to develop a common understanding among plant pathologists of the language and metrics of diagnostic assay validation, and to explore aspects of diagnostic assay validation research planning. Workshop participants provided generally positive feedback on the presentations, exercises, and breakout sessions in a post-workshop survey, with suggestions to focus on issues of sampling, sample size and statistics and experimental design for diagnostic assay validation.

Technical Abstract: A one-day workshop entitled ‘Principles of Validation for Plant Pathogen Diagnostic Assays’ was held August 5th, 2017 in San Antonio, TX, organized by the authors of this report, and attended by 65 participants. This review is a summary of the content of that workshop and is presented to further discussion on the science and practice of diagnostic assay validation, upon which are based the assays so critical to protecting plant health and safeguarding trade. The workshop was attended by a spectrum of academic, federal/state government and industry, researchers and students. The objectives of the workshop were to develop a common understanding among plant pathologists of the language and metrics of diagnostic assay validation, and to explore the modalities of validation research planning. There were three sets of activities: presentations concerning ‘Fitness for Purpose’; exercises to demonstrate how to calculate metrics of validation; and finally group work on five classes of plant pathogens to understand commonalities and distinctions in assay validation research. Workshop participants provided generally positive feedback on the presentations, exercises, and breakout sessions in a post-workshop survey, with suggestions to focus on issues of sampling, sample size and statistics and experimental design for diagnostic assay validation.