0-59天婴儿严重细菌感染（包括新生儿败血症）的体外诊断试验：目标产品概况

target product profile In vitrodiagnostic tests for seriousbacterial infection, including neonatalsepsis, among infants aged 0–59 days target product profile In vitro diagnostic tests for serious bacterial infection, including neonatal sepsis, among infants aged 0–59 days: targetproduct profile ISBN 978-92-4-011301-5 (electronic version)ISBN 978-92-4-011302-2 (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 adapt the work,then you must license your work under the same or equivalent Creative Commons licence. If you create a translation ofthis work, you should add the following disclaimer along with the suggested citation: “This translation was not createdby the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. Theoriginal 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 rulesof the World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/). Suggested citation.In vitro diagnostic tests for serious bacterial infection, including neonatal sepsis, among infantsaged 0–59 days: target product profile. Geneva: World Health Organization; 2025. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.CIP data are available at https://iris.who.int/. Sales, rights and licensing.To purchase WHO publications, see https://www.who.int/publications/book-orders. Tosubmit requests for commercial use and queries on rights and licensing, see https://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, figuresor images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permissionfrom the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in thework 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, cityor area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines onmaps represent 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 endorsed orrecommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted,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,the published material is being distributed without warranty of any kind, either expressed or implied. The responsibilityfor the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arisingfrom its use. Design and layout by Inis Communication Contents AcknowledgementsvAbbreviationsviiGlossaryvii1 Introduction11.1 Background11.2 Purpose and target audience11.3 Scope12 Methods32.1 Overview32.2 Establishment of the development group32.3 Initial draft32.4 Delphi survey32.5 Public consultation43 Target product profile5References12Annex1. Definitions of target use settings andhealth-facility levels14Annex2. Composition of the development group15Annex3. Summary of modelling analysis and its role in informingthe target product profile17 List of tables Table 1. Target product profile:in vitrodiagnostic tests for serious bacterial infection,including bacterial sepsis, among infants aged 0–59 days5Table A1.1. Definitions of target use settings and health-facility levels14Table A2.1. Geographical distribution of the target product profiledevelopment group members and respondents to the public consultation15Table A3.1. Target product profile criteria that were informed by modelling19 List of figures Fig. 1. Response count and percentage agreement of the target product profile development groupmembers for each target product profile characteristic in the Delphi survey4 Fig. A2.1. Characteristics of the target product profile development group members:types of work16 Acknowledgements Chad Centner (Surveillance, Evidence