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Disease/health condition - HIV infection, Tuberculosis (TB)
Lipoarabinomannan (LAM) antigen
Setting:
1. Non-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
Lateral flow RDT
Information History
First added in 2018
Changed in 2024
Purpose type
Diagnosis
Purpose
Initial test for TB diagnosis. For adults and adolescents living with HIV and children with HIV.
Specimen types
Urine
WHO prequalified or recommended products
Products recommended by WHO/GTB will also undergo WHO PQ assessment.
GMDN

51172

Mycobacterium tuberculosis complex species antigen IVD, kit, rapid ICT, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from bacterial species of the Mycobacterium tuberculosis complex (e.g., M. tuberculosis, M. bovis, M. bovis Bacillus Calmette-Guerin, M. africanum, M. canetti, M. microti, M. caprae, M. pinnipedii, M. orygis) in a clinical specimen and/or culture isolate within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method* . This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
* lateral flow test
EMDN

W0105090199

BACTERIOLOGY - RT & POC - OTHER

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
World Health Organization. (‎2019)‎. Lateral flow urine lipoarabinomannan assay (‎LF-LAM)‎ for the diagnosis of active tuberculosis in people living with HIV: policy update 2019. World Health Organization. https://iris.who.int/handle/10665/329479 ; 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
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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