欧洲疾控中心-欧盟结核病实验室诊断方法手册-2025年更新（英）_148页_4mb

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Summary of the Handbook on Tuberculosis Laboratory Diagnostic Methods in the European Union (Updated 2025)

Core Content

This document is the fifth edition of the Handbook on tuberculosis laboratory diagnostic methods in the European Union, updated in 2025. It is a comprehensive guide for laboratories involved in the diagnosis of tuberculosis (TB) and nontuberculous mycobacteria (NTM) in the European Union (EU) and European Economic Area (EEA). The handbook serves as a reference for standard and evidence-based diagnostic methods, aiming to improve the quality, consistency, and safety of TB diagnosis across Europe.

Main Objectives

To provide a unified reference for key diagnostic methods used in TB diagnosis.
To support the harmonisation of diagnostic practices across EU/EEA countries.
To enhance the accuracy and reliability of TB and NTM testing through quality assurance and biosafety protocols.
To facilitate the integration of new technologies, such as molecular assays and whole genome sequencing (WGS), into diagnostic workflows.

Key Chapters and Their Focus

Chapter	Focus
1	Biosafety and biosecurity in TB diagnostic laboratories, including risk assessment, containment, PPE, and emergency preparedness.
2	Laboratory accreditation and quality management, including ISO 15189 standards, quality assessment, and accreditation of advanced methods like WGS.
3	Diagnosis of TB infection, focusing on tuberculin skin tests (TST) and interferon-gamma release assays (IGRAs), including their clinical use and interpretation.
4	Smear microscopy techniques, such as Ziehl-Neelsen (ZN) and fluorochrome staining, along with reagent preparation, sample handling, and quality control.
5	Culture methods for Mycobacterium tuberculosis complex (MTBC), including specimen handling, decontamination, media types, and incubation protocols.
6	Molecular assays for rapid TB and drug-resistant TB detection, including line probe assays (LPA), real-time PCR, and next-generation sequencing (NGS).
7	Phenotypic antimicrobial susceptibility testing (AST) for MTBC, including methods like the proportion method on Löwenstein-Jensen (LJ) medium and broth microdilution.
8	Molecular typing methods for MTBC isolates, covering traditional techniques like spoligotyping and IS6110 RFLP, as well as modern NGS-based approaches.
9	Use and validation of disinfectants for M. tuberculosis, including liquid and gaseous methods and their efficacy testing.
10	Information for physicians on the laboratory diagnosis of TB, including specimen collection, reporting, and communication between microbiologists and clinicians.
11	Diagnosis of nontuberculous mycobacteria (NTM), covering epidemiology, clinical presentations, sampling instructions, and molecular and phenotypic testing methods.

Main Views and Key Information

Biosafety and Biosecurity: Essential for preventing laboratory-acquired infections. The handbook outlines risk assessment frameworks, biosafety levels (BSL), and biosecurity measures, including access control, staff security, and inventory management.
Quality Assurance and Accreditation: Emphasises the importance of accreditation standards (e.g., ISO 15189) and quality management systems. It includes guidance on internal and external quality assessment (IQA and EQA), as well as the implementation of standard operating procedures (SOPs).
Diagnostic Methods: Covers a range of diagnostic approaches, including:
- Smear microscopy: Traditional ZN and fluorochrome methods, with emphasis on quality control and staining procedures.
- Culture: For MTBC, including specimen handling, decontamination, and the use of solid and liquid media.
- Molecular diagnostics: Line probe assays (LPA), real-time PCR, and NGS-based techniques, including targeted NGS and WGS, which are increasingly used for drug resistance prediction and strain typing.
- Phenotypic testing: AST methods such as the proportion method and broth microdilution, with details on MIC determination using EUCAST reference methods.
NTM Diagnosis: Highlights the growing importance of NTM diagnostics, including sampling instructions, molecular methods, and the use of IGRAs, smear microscopy, and culture. It also discusses challenges in molecular testing and the role of phenotypic methods and MALDI-TOF mass spectrometry.
Integration of New Technologies: The handbook reflects the evolving landscape of TB diagnostics, particularly the shift from centralized "big laboratory" models to decentralized "point-of-care" devices, and highlights the role of NGS in drug resistance prediction and strain analysis.
Collaboration and Network Support: The handbook is a product of the European Reference Laboratory Network for Tuberculosis (ERLTB-Net), which aims to harmonize diagnostic methods, develop EQA schemes, and provide training to support TB control across Europe.

Intended Use

This handbook is intended for:

Laboratory experts involved in TB and NTM diagnosis.
Public health professionals working on TB control initiatives.
Physicians seeking guidance on interpreting laboratory results for TB diagnosis.

It serves as a reference guide, not a mandatory protocol, and is meant to support the validation, development, and dissemination of diagnostic methods in Europe.

Conclusion

The Handbook on tuberculosis laboratory diagnostic methods in the European Union – Updated 2025 is a vital resource for ensuring accurate, reliable, and safe TB diagnosis. It addresses both traditional and modern diagnostic approaches, reflecting the latest scientific evidence and technological advancements, and aims to support the implementation of high-quality diagnostic practices across the EU and EEA.

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