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Disease/health condition -
Tuberculosis (TB)
Culture-based drug susceptibility testing (DST) of antituberculosis drugs
Assay format
Manual techniques
Information History
First added in 2018
Changed in 2024
Purpose type
Diagnosis, Monitoring
Purpose
To detect resistance to first-line and/or second-line anti-TB medicines.
Specimen types
M. tuberculosis culture isolates
WHO prequalified or recommended products
N/A
GMDN
62407
Anti-tuberculosis (anti-TB) drug susceptibility testing reagent kit IVD
A collection of reagents and other associated materials intended to be added to a culture medium containing a culture isolate of Mycobacteruim tuberculosis from a clinical specimen, to determine antimicrobial susceptibility to an anti-tuberculosis drug* .
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* e.g., pyrazinamide (PZA)
EMDN
W0104010699
MEDIA FOR MYCOBACTERIAL CULTURES - MANUAL & AUTOMATED (FOR AST DRUGS, SUPPLEMENTS) - 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/emdnWHO 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 C: technical manual for culture-based drug susceptibility testing of anti-tuberculosis drugs used in the treatment of tuberculosis, 3rd ed. World Health Organization. https://iris.who.int/handle/10665/376286
Technical specifications
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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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