欧盟结核病实验室诊断方法手册 2025年更新

Updated 2025 ECDCOPERATIONAL SUPPORT Handbook on tuberculosis laboratorydiagnostic methods in the European Union Updated 2025 This report of the European Centre for Disease Prevention and Control (ECDC) was coordinated by Csaba Ködmönwith support from Marieke J van der Werf, Daniela Maria Cirillo, and Elisa Tagliani. This report was sent for consultation to the members of ERLTB-Net (see Annex 3 for list of contributors). The first version of this ECDC technical report, previously published as ‘Mastering the basics of TB control:Development of a handbook on TB diagnostic methods’ (Stockholm 2011), concerned the development of thehandbook. This report was then revised and renamed ‘Handbook on TB laboratory diagnostic methods in theEuropean Union’ in 2016, and subsequently in 2018 ‘Handbook on tuberculosis laboratory diagnostic methods in theEuropean Union – Updated 2018’. As new scientific evidence became available, a further revision was undertaken in2022, and four chapters were updated (chapters 6, 7, 8, and 10). In this version, published in 2025, two chapterswere updated (chapters 1 and 2) and one new chapter was added (chapter 11). European Centre for Disease Prevention and Control. Handbook on tuberculosis laboratory diagnostic methods inthe European Union – Updated 2025. Stockholm: ECDC; 2025. Stockholm, December 2025 ISBN 978-92-9498-853-9doi 10.2900/2075970Catalogue number TQ-01-25-083-EN-N Contents Abbreviations ................................................................................................................................................8Background and introduction ........................................................................................................................10How this handbook relates to other work available in this field ................................................................................... 10What this document is/is not ........................................................................................................................................10Intended use and users................................................................................................................................................11History of the handbook ...............................................................................................................................................11This edition...................................................................................................................................................................111 Biosafety in clinical laboratory diagnosis of TB ....................................................................................112 Quality assurance ............................................................................................................................113 TB infection.....................................................................................................................................114 Smear microscopy............................................................................................................................125 Culture forMycobacterium tuberculosis complex.................................................................................126 Molecular assays for rapid TB and drug-resistant TB detection .............................................................127 Phenotypic-based antimicrobial susceptibility testing forMycobacterium tuberculosis complex ................128 Molecular typing ofMycobacterium tuberculosis complex isolates .........................................................129 Use and validation of disinfectants forMycobacterium tuberculosis.......................................................1210 Information for physicians: the laboratory diagnosis of TB..................................................................1211 The diagnosis of nontuberculous mycobacteria .................................................................................12Disclaimer.....................................................................................................................................................................121 Biosafety and biosecurity in tuberculosis diagnostic laboratories ....................................................................131.1 Introduction............................................................................................................................................................131.2 Principles of risk assessment for laboratories diagnosing tuberculosis...................................................................... 131.3 Risk control measures.............................................................................................................................................141.3.1 Good microbiological practice and procedures...............................................................................141.3.2 Facility design, equipmen