Terminology and Guidelines for Diagnostic Assay Development and Validation: Best Practices for Molecular Tests

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. The 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. [Figure: see text] Copyright © 2023 The Author(s). This is an open access article distributed under the CC BY 4.0 International license.

Keywords

• diagnostics
• fitness
• precision
• repeatability
• reproducibility
• robustness