Skip to main content
ARS Home » Pacific West Area » Salinas, California » Crop Improvement and Protection Research » Research » Publications at this Location » Publication #394446

Research Project: Disease Management and Improved Detection Systems for Control of Pathogens of Vegetables and Strawberries

Location: Crop Improvement and Protection Research

Title: Terminology and guidelines for diagnostic assay development and validation: Best practices for molecular tests

item GROTH-HELMS, D - Agdia
item RIVERA, YASMIN - Animal And Plant Health Inspection Service (APHIS)
item Martin, Frank
item ARIF, MOHAMMAD - University Of Hawaii
item SHARMA, POONMAN - Oklahoma State University
item Castlebury, Lisa

Submitted to: PhytoFrontiers
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 8/22/2022
Publication Date: 5/22/2023
Citation: Groth-Helms, D., Rivera, Y., Martin, F.N., Arif, M., Sharma, P., Castlebury, L.A. 2023. Terminology and guidelines for diagnostic assay development and validation: Best practices for molecular tests. PhytoFrontiers. 3(1):23-35.

Interpretive Summary: This manuscript describes terminology and technological approaches that are important to keep in mind when developing molecular diagnostic assays for detection of economically important plant pathogens to ensure the assays perform properly under a range of conditions.

Technical Abstract: Effective use of diagnostic assays is essential for the early detection of plant pathogens and mitigation of potential disease impacts. Assay developers require a full understanding of the intended use of a test to address complicating factors that might be observed by an end user and limit the utility of the test and its scope of application in the field. Fitness of a test for a disease prevention application is determined by its performance characteristics, which are selected during assay design and defined during validation. This paper provides guidance to developers by standardizing the descriptions of key validation terms and concepts, including tiers that can be referenced in publications to better communicate the extent to which a test has been validated. These concepts are then applied in the broader context of a strategic approach to validation for various taxa and methods. The aim of this paper is to increase awareness of common pitfalls and gaps encountered during this process with the goal of increased success in technology transfer. Recommendations are given for improving the efficiency and quality of test development through improved coordination among stakeholders.