Standards of Diagnostic Validation: Recommendations for Reference Collections

Abstract

Agricultural and ecosystem biosecurity requires accurate and reliable diagnostic data provided by systems of people, technologies, and validated diagnostic assays. Biological reference collections, including living and preserved microbe culture collections, and authenticated sequence databases are essential for development and validation of robust diagnostic assays, as well as breeding for disease resistance. However, the lack of standardized requirements for long-term preservation, curation, recordkeeping, and data provenance of collections poses a significant risk to this research. Several examples of successful collections and funding models exist, but these are disparate, disconnected, and lack standards for harmonization among them. We recommend a framework for coordinated development, long-term maintenance, and accessibility of curated sets of pathogen data representing cultures and other reference material that could serve the needs of pathogen diagnostics development, population studies, and resistance breeding efforts. [Figure: see text] Copyright © 2023 The Author(s). This is an open access article distributed under the CC BY-NC-ND 4.0 International license.

Keywords

• collection registry
• culture collection
• diagnostic validation
• reference standard
• voucher specimen