在监测背景下检测黄热病的体外诊断试验的目标产品概况

Target product profile on in vitro diagnostic assays for the detection of yellow fever in the context ofsurveillance ISBN 978-92-4-011329-9 (electronic version)ISBN 978-92-4-011330-5 (print version) © World Health Organization 2025 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO 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,provided the work is appropriately cited, as indicated below. In any use of this work, there should be nosuggestion that WHO endorses any specific organization, products or services. The use of the WHO logo isnot permitted. If you adapt the work, then you must license your work under the same or equivalent CreativeCommons licence. If you create a translation of this work, you should add the following disclaimer along withthe suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is notresponsible for the content or accuracy of this translation. The original English edition shall be the binding andauthentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with themediation rules of the World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/). Suggested citation.Target product profile on in vitro diagnostic assays for the detection of yellow fever in thecontext of surveillance. 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.To submit 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 astables, figures or images, it is your responsibility to determine whether permission is needed for that reuseand to obtain permission from the copyright holder. The risk of claims resulting from infringement of anythird-party-owned component in the work rests solely with the user. General disclaimers.The designations employed and the presentation of the material in this publication donot imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of anycountry, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.Dotted and dashed lines on maps represent approximate border lines for which there may not yet be fullagreement. The mention of specific companies or of certain manufacturers’ products does not imply that they areendorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errorsand 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 orimplied. The responsibility for the interpretation and use of the material lies with the reader. In no event shallWHO be liable for damages arising from its use. Contents AcknowledgementsiiConflict of interest statementiiAbbreviations and acronymsiiiOverview1Purpose2Rationale2Laboratory testing for yellow fever surveillance3Molecular assays3Serological assays3Antigen capture assays3TPP development methodology4Conclusion5Table 1. Standardized yellow fever molecular test kit6Table 2. Standardized YF immunoglobulin M ELISA test kit9Table 3. Rapid yellow fever immunoglobulin M test12Table 4. Rapid yellow fever antigen test15References18 Acknowledgements The World Health Organization (WHO) would like to thank the many individuals who contributed to thedevelopment of this publication entitled “Target product profiles on in vitro diagnostic assays for the detectionof yellow fever in the context of surveillance”. The document was conceptualized by Jean-François Lemaire,Mick Mulders, and Anindya Bose (Department of Immunization, Vaccines, and Biologicals, WHO headquarters).The development of these target product profiles (TPPs) was led by Jean-François Lemaire and guidancewas provided by Mercedes Perez Gonzalez and Sandra Ifeyinwa Nwokeoha (Research for Health, WHOheadquarters). WHO acknowledges the contribution and technical inputs of the following experts throughout thedevelopment of these TPPs: Ngu Abanda (Centre Pasteur du Cameroun, Cameroon), David Dolinger (DLD IVD Consulting, United States ofAmerica), Cristina Domingo-Carrasco (Robert Koch Institute, Germany), Gamou Fall (Institut Pasteur de Dakar,Senegal), Léa Gangoue (Congo National Yellow Fever Reference Laboratory, Con