Interpretation of the fouth edition of WHO consolidated guidelines on tuberculosis, Module 3:diagnosis

doi:10.19983/j.issn.2096-8493.20250072

Abstract

Abstract:

On April 16, 2025, the World Health Organization (WHO) officially released the fourth edition of the WHO Consolidated Guidelines on Tuberculosis, Module 3: Diagnosis. This edition, for the first time, consolidates policy guidance on testing for tuberculosis (TB) diagnosis, drug resistance and infection. It established two new classes of TB diagnostic tests for the initial detection of TB and resistance to rifampicin, and introduces new recommendations on concurrent testing of respiratory and non-respiratory samples for the initial detection of TB and resistance to rifampicin for adults and adolescents living with HIV, children living with HIV, and children without HIV or with unknown HIV status. The author interprets the key updates in the guideline to support clinicians in understanding and implementing the revised recommendations in practice.

Key words: World Health Organization, Guidebooks, Tuberculosis, Drug tolerance

CLC Number:

Ding Feng, Lu Shuihua. Interpretation of the fouth edition of WHO consolidated guidelines on tuberculosis, Module 3:diagnosis[J]. Journal of Tuberculosis and Lung Disease , 2025, 6(6): 624-633. doi: 10.19983/j.issn.2096-8493.20250072

技术类别	推荐产品
含有耐药性检测的结核病诊断初始检测
新增:用于结核病检测和利福平耐药性检测的低复杂度自动化NAATs^a	Xpert^? MTB/RIF, Xpert MTB/RIF Ultra (Cepheid) Truenat^? MTB Plus, Truenat MTB-RIF Dx (Molbio)
用于结核病检测及对利福平和异烟肼的耐药性检测的中复杂度自动化NAATs	Abbott RealTime^? MTB, Abbott RealTime MTB RIF/INH (Abbott) BD MAX^TM MDR-TB (Becton Dickinson) cobas^? MTB, cobas MTB-RIF/INH (Roche) FluoroType^? MTB, FluoroType MTBDR (Hain Lifescience/Bruker)
不含耐药性检测的结核病诊断初始检测
新增:低复杂度手动NAATs^b	Loopamp^TM MTBC Detection Kit (TB LAMP)(Eiken Chemical)
横向流动格式的抗原检测(基于生物标志物的检测)[侧流尿脂阿拉伯甘露聚糖测定法(LF-LAM)]	Determine^TM TB LAM Ag (Alere/Abbott)
结核病耐药性检测的后续筛查检测
用于检测异烟肼和二线抗结核药物耐药性的低复杂度自动化NAATs	Xpert^? MTB/XDR (Cepheid)
用于结核病耐药性检测的线性探针杂交试验(LPAs)	GenoType^? MTBDRplus v1和v2, GenoType MTBDRsl (Hain Lifescience/Bruker) Genoscholar^TM NTM+MDRTB Ⅱ, Genoscholar PZA-TB Ⅱ (Nipro)
用于结核病耐药性检测的靶向新一代测序(NGS)试验	Deeplex^? Myc-TB (GenoScreen/Illumina) AmPORE-TB^? (Oxford Nanopore Technologies) TBseq^? (圣庭医疗)
结核分枝杆菌感染检测
结核分枝杆菌抗原皮肤试验(TBSTs)	Diaskintest^? (Generium) Siiltibcy^TM (Serum Institute of India) C-TST (安徽智飞龙科马)
γ-干扰素释放试验(IGRAs)	T-SPOT.TB (T-SPOT)(Revvity) TB-IGRA (万泰生物) QuantiFERON-TB Gold Plus (QFT-Plus)(QIAGEN) STANDARD E TB-Feron ELISA (SD BIOSENSOR) LIAISON QFT-Plus CLIA (Diasorin)
结核菌素皮肤试验(TST)	tuberculin purified protein derivative (PPD)相关产品

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[3]	World Health Organization. Implementing the End TB Strategy: the essentials. Geneva: World Health Organization, 2015.
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Interpretation of the fouth edition of WHO consolidated guidelines on tuberculosis, Module 3:diagnosis

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