The need and a vision for a diagnostic assay validation network

Authors: CARDWELL, KITTY - Oklahoma State University; HARMON, CARRIE - University Of Florida; Luster, Douglas - Doug; STACK, JAMES - Kansas State University; HYTEN, AIMEE - Animal And Plant Health Inspection Service (APHIS); SHARMA, POONAM - Oklahoma State University; NAKHLA, MARK - Animal And Plant Health Inspection Service (APHIS)

Submitted to: PhytoFrontiers
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 12/2/2022
Publication Date: 3/1/2023
Citation: Cardwell, K.F., Harmon, C.L., Luster, D.G., Stack, J.P., Hyten, A.M., Sharma, P., Nakhla, M.K. 2023. The need and a vision for a diagnostic assay validation network. PhytoFrontiers. 3:9-17. https://doi.org/10.1094/PHYTOFR-05-22-0056-FI.
DOI: https://doi.org/10.1094/PHYTOFR-05-22-0056-FI

Interpretive Summary: Plant biosecurity depends heavily on early and accurate detection and diagnosis, feeding communication chains that allow for effective mitigation. The system for plant disease diagnostic assay development, validation, and selection is unorganized, representing a critical weakness in our biosecurity infrastructure, especially for new or emerging pathogens. This system should be connected, integrated, and standardized to ensure a consensus on the standards of method validation for each taxon. We must harmonize and share validation standards, validated protocols and essential controls with our neighbors and trade partners for use in emergencies as well as day-to-day detection. Extensive collaboration in the sciences of plant disease diagnostic assay development and validation, reference standards, and communications platforms does not currently exist and is acutely needed. We propose development of a Diagnostic Assay Validation Network (DAVN) system to provide coordinating resources at the national level and harmonize with our partners at the international level. We outline a project to stand up a DAVN with the objectives to standardize the reference standards, terminology, and statistics used in diagnostic assay development and validation via a portal of tools to be made widely available to the research and extension community.

Technical Abstract: Plant biosecurity depends heavily on early and accurate detection and diagnosis, feeding communication chains that allow for effective mitigation. In the U.S., most land-grant university and some state/private diagnostic labs are successfully networked via the National Plant Diagnostic Network, with access to training, shared protocols, and standardized communications. However, the ecosystem for plant disease diagnostic assay development, validation, and selection is decentralized, representing a critical weakness in our biosecurity infrastructure, especially for new or emerging pathogens. In essence, every assay is developed independently in a research program and then chosen independently by the end-use laboratory. This system should be connected, integrated, and standardized to ensure a consensus on the standards of method validation for each taxon. We must harmonize and share validation standards, validated protocols and essential controls with our neighbors and trade partners for use in emergencies as well as day-to-day detection. Extensive collaboration in the tactical sciences of plant disease diagnostic assay development and validation, reference standards, and communications platforms does not currently exist and is acutely needed. We propose development of a Diagnostic Assay Validation Network (DAVN) system to provide coordinating resources at the national level and harmonize with our partners at the international level. Here, we outline a project to stand up a DAVN with the objectives to standardize the reference standards, terminology, and statistics used in diagnostic assay development and validation via a portal of tools to be made widely available to the research and extension community.