市售和管道中细菌优先病原体体外诊断的景观分析

Landscape analysis ofcommercially available andpipeline in vitro diagnostics forbacterial priority pathogens Landscape analysis of commercially available and pipeline in vitro diagnostics for bacterial priority pathogens ISBN 978-92-4-010982-7 (electronic version)ISBN 978-92-4-010983-4 (print version) © World Health Organization 2025 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0IGO licence (CC BY-NC-SA 3.0 IGO;https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, providedthe work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHOendorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adaptthe work, then you must license your work under the same or equivalent Creative Commons licence. If you create atranslation of this work, you should add the following disclaimer along with the suggested citation: “This translationwas not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of thistranslation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules ofthe World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/). Suggested citation. Landscape analysis of commercially available and pipeline in vitro diagnostics for bacterial prioritypathogens. Geneva: World Health Organization; 2025. Licence:CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available athttps://iris.who.int/. Sales, rights and licensing. To purchase WHO publications, seehttps://www.who.int/publications/book-orders. Tosubmit requests for commercial use and queries on rights and licensing, seehttps://www.who.int/copyright. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables,figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtainpermission from the copyright holder. The risk of claims resulting from infringement of any third-party-ownedcomponent in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not implythe expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city orarea or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on mapsrepresent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsedor recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissionsexcepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, thepublished material is being distributed without warranty of any kind, either expressed or implied. The responsibility forthe interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising fromits use. Design and layout by 400 Communications Limited. Contents AcknowledgementsivAbbreviationsvExecutive Summaryvii1.Introduction22.In vitro diagnostics for the detection and identification of bacterial priority pathogens103.In vitro diagnostics for antimicrobial susceptibility testing and antibacterial resistancetesting of bacterial pathogens204.Future directions of diagnostics for bacterial priority pathogens255.Discussion286.Research and development recommendations for diagnostics for bacterialpriority pathogens317.References34Annex 1Declaration of interests of expert group members41Annex 2Commercially available diagnostics for detection, identification, and antimicrobialsusceptibility and antibacterial resistance testing of priority bacterial pathogens42Annex 3Pipeline diagnostics for detection, identification and antimicrobial susceptibilityand antibacterial resistance testing of bacterial priority pathogens153Annex 4Diagnostic platforms for all levels of the health-care system161 Acknowledgements •Oon Tek Ng, Antimicrobial Resistance CoordinatingOffice, National Centre for Infectious Diseases,Singapore•Pascale Ondoa, The Global Fund to fight AIDS,Tuberculosis and Malaria, Switzerland•Huda Ziad Ali Al-Shami, National Focal Point forAntimicrobial Resistance Surveillance, Yemen•Selina Poon, Antimicrobial Resistance CoordinatingOffice, National Centre for Infectious Diseases,Singapore•Susan Poutanen, Mount Sinai Hosp