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Disease/health condition - Tuberculosis (TB)
Mycobacterium tuberculosis nucleic acid amplification test
Setting:
2. Laboratory
Tiered Testing Service:
WHO 2025 operational handbook on TB
Tiered Testing Service Information:

Recommendations from WHO GTB can be found in the 2025 WHO operational handbook on tuberculosis. Module 3: diagnosis available at https://iris.who.int/handle/10665/382121

Assay format
Moderate-complexity automated NAAT
Information History
First added in 2024
Purpose type
Diagnosis
Purpose
Initial test for TB diagnosis. To detect pulmonary TB.
Specimen types
Sputum, Tracheal aspirate, Bronchoalveolar lavage
WHO prequalified or recommended products
Products recommended by WHO/GTB will also undergo WHO PQ assessment.
WHO supporting publications
World Health Organization. (‎2025)‎. WHO consolidated guidelines on tuberculosis: module 3: diagnosis. World Health Organization. https://iris.who.int/handle/10665/381003 ; World Health Organization. (‎2025)‎. WHO operational handbook on tuberculosis: module 3: diagnosis. World Health Organization. https://iris.who.int/handle/10665/382121 ; World Health Organization. (‎2024)‎. WHO operational handbook on tuberculosis: module 3: diagnosis: rapid diagnostics for tuberculosis detection: web annex A: information sheets, 3rd ed. World Health Organization. https://iris.who.int/handle/10665/376284
Technical specifications
Information sheets on products recommended by WHO/GTB can be found in the 2024 Web Annex A. Information sheets. In: WHO operational handbook on tuberculosis. Module 3: diagnosis – rapid diagnostics for tuberculosis detection, third edition available at https://iris.who.int/handle/10665/376284
Related diagnostics for tuberculosis

Recommendations from WHO GTB can be found in the 2025 WHO operational handbook on tuberculosis. Module 3: diagnosis available at https://iris.who.int/handle/10665/382121

SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte and the availability of WHO guidelines and technical reports, including recommendations for the use of this test. The selection of disease specific tests for the EDL also took into account relevant priority diseases for WHO such as NCDs including DM, CVD and cancer, HIV infection, malaria, NTDs, STIs, tuberculosis, viral hepatitis B and C, among others.
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The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
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