WHO operational handbook on tuberculosis: module 3: diagnosis: rapid diagnostics for tuberculosis detection

This operational handbook provides practical guidance for the implementation of WHO policies and recommendations on rapid diagnostic technologies for tuberculosis (TB) and drug-resistant tuberculosis (DR-TB). The publication describes WHO-recommended diagnostic tests and testing algorithms for the detection of Mycobacterium tuberculosis complex and resistance to anti-TB medicines, including molecular WHO-recommended rapid diagnostic tests, line-probe assays, lateral flow lipoarabinomannan assays, and nucleic acid amplification technologies for first- and second-line drug resistance testing. It also summarizes the intended use, diagnostic performance and operational characteristics of these technologies within TB laboratory networks.

The handbook further outlines key considerations for introducing new diagnostic tools into national TB programmes, including laboratory infrastructure, quality assurance, biosafety, specimen referral systems, training, connectivity and budgetary planning. Model diagnostic algorithms aligned with current WHO recommendations are presented for the diagnosis of TB and DR-TB and for the detection of resistance to rifampicin, isoniazid, fluoroquinolones and other anti-TB medicines. The document is intended to support ministries of health, programme managers, laboratory specialists, clinicians and other stakeholders involved in TB laboratory strengthening and implementation of diagnostic services.