Standards Development

Scope

This document will provide general requirements and guidelines for the detection of specific antimicrobial resistance (AMR) determinants in bacteria as identified by whole genome sequencing. This document will include details on the detection of AMR mechanisms and prediction of AMR in a range of bacterial species. The document will include both verified whole genome sequences and targeted analysis. The scope includes a One Health approach for a document formally applicable to bacteria isolated from the food chain but with the purpose to be applicable also to bacteria covered by ISO/TC 34/SC 16 Horizontal methods for molecular biomarker analysis, bacteria isolated from clinical samples, covered by ISO/TC 212 Medical laboratories and in vitro diagnostic systems, as well as bacteria isolated from animals, as covered by the World Organization for Animal Health (WOAH).

Purpose

The development of an ISO standard for AMR detection and prediction of resistance in bacteria using WGS (Whole Genome Sequencing) data has emerged as a critical consideration in different areas of global health (human, animal, plant and environmental health). WGS data has become increasingly important in many fields, including human and animal health, agriculture, food production and processing, life sciences and environmental research. With increasing use of WGS data, there is a rising interest and recognition of the importance for standardized methods for using WGS data to ensure consistency, reliability and comparability of data analysis worldwide.

Developing an ISO standard on AMR detection and prediction of resistance using WGS data would ensure findability, accessibility, interoperability and reusability (FAIR) across different sequencing platforms and technologies. It would provide a framework for bioinformatics data analysis and application programming interfaces, allowing researchers and practitioners to better compare and replicate results. This standardization would enhance the reproducibility and reliability of WGS data analysis, leading to better insights and more relevant decision-making.

Collaboration of ISO/TC 34/SC 9 (i) within ISO with ISO TC 34/SC 16 “Horizontal methods for molecular biomarker analysis”, ISO/TC 212 “Medical laboratories and in vitro diagnostic systems” and (ii) outside ISO, in particular WOAH, would bring together the relevant expertise needed in a One Health context to address both technical and clinical aspects of WGS data use and would be beneficial in developing a comprehensive ISO standard being applicable to these different fields.

In summary, developing an ISO standard on AMR detection and prediction of resistance using WGS data is necessary to ensure consistency, interoperability, and reproducibility in data analysis. The feasibility of developing such a standard is high, due to the existing technological advancements and the increasing recognition of the importance of standardization in genomics. In addition, AHG 5 of ISO/TC 34/SC 9 has been active in conducting preparatory works and has prepared the enclosed draft standard, submitted to new work item proposal ballot.