Skip to main content
ARS Home » Northeast Area » Frederick, Maryland » Foreign Disease-Weed Science Research » Research » Publications at this Location » Publication #393861

Research Project: Developing Genomic and Biological Resources to Characterize, Diagnose and Detect Emerging and Invasive Vectored Bacterial and Viral Plant Pathogens for Safeguarding U.S. Agriculture

Location: Foreign Disease-Weed Science Research

Title: Perspective: State of the field of plant pathogen diagnostic assay development and validation

Author
item SHARMA, POONAM - Oklahoma State University
item Luster, Douglas - Doug
item CARDWELL, KITTY - Oklahoma State University

Submitted to: PhytoFrontiers
Publication Type: Literature Review
Publication Acceptance Date: 9/28/2022
Publication Date: 10/11/2022
Citation: Sharma, P., Luster, D.G., Cardwell, K.F. 2022. Perspective: State of the field of plant pathogen diagnostic assay development and validation. PhytoFrontiers. https://doi.org/10.1094/PHYTOFR-05-22-0054-FI.
DOI: https://doi.org/10.1094/PHYTOFR-05-22-0054-FI

Interpretive Summary: Diagnostic assays for plant pathogens are a critical component in the surveillance, detection, and management of disease in the production of food, feed, and fiber. Producers, crop consultants, state and federal officials depend upon rapid and accurate diagnostics for response, disease mitigation, crop management and regulatory decisions affecting trade and export prices. Diagnostic assays undergoing development must be validated to understand how well the assay will perform on given samples, in different users hands, and under varying laboratory conditions before deployment and application in diagnostic clinics and/or distributed as commercially available assays. Our survey of recent publications describing the development of diagnostics for plant pathogens found that those detailing an appropriate and robust diagnostic assay validation process were few in number. The results point out the need for broad application of standards and rigor in the conception, development and execution of diagnostic assay validation.

Technical Abstract: Diagnostic assays for plant pathogens are a critical component in the surveillance, detection, and management of disease in the production of food, feed, and fiber. Producers, crop consultants, state and federal officials depend upon rapid and accurate diagnostics for response, disease mitigation, crop management and regulatory decisions affecting trade and export prices. Diagnostic assays undergoing development must be validated to understand how well the assay will perform on given sample matrices, in different users hands, and under varying laboratory conditions before deployment and application in diagnostic clinics and/or distributed as commercially available assays. The validation of diagnostic assays is a time consuming, expensive, multi-tiered process, requiring pathogen and near neighbor reference materials, barcode and/or genome sequence data, and cross- laboratory partnerships. Regulatory agencies and diagnostic clinics do not often have fully validated assays to deploy during an outbreak of a novel pathogen. Our survey of recent publications describing the development of diagnostics for plant pathogens found that those detailing an appropriate and robust diagnostic assay validation process were few in number. The results point out the need for broad application of standards and rigor in the conception, development and execution of diagnostic assay validation.