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Disease/health condition - Tuberculosis (TB)
Mycobacterial culture
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
Automated systems
Information History
First added in 2018
Changed in 2024
Purpose type
Diagnosis, Monitoring
Purpose
To diagnose and monitor treatment of active TB, including drug resistant TB.
Specimen types
Sputum, Tracheal aspirate, Bronchoalveolar lavage, Nasopharyngeal aspirate, Gastric aspirate, Stool, Cerebrospinal fluid, Lymph node aspirate, Pleural tissue, Pleural fluid, Synovial fluid, Peritoneal fluid, Pericardial fluid
WHO prequalified or recommended products
N/A
GMDN

61712

Microbial specimen inoculation/streaking/colony-picking instrument IVD

An electrically-powered instrument intended for the pre-analytical preparation of microbial samples (e.g., cultures, suspensions, MALDI-TOF targets/slides) from a clinical specimen and/or culture isolate. Its functionality includes: 1) automated/semi-automated transfer of the clinical specimen (e.g., by aspiration or inoculating loop), inoculation into/onto culture dishes/tubes/slides, and streaking of culture dishes (e.g., using magnetic beads, inoculation loops or spreaders); and/or 2) automated microbial colony picking for the preparation of samples for subsequent analytical procedures. It may also feature processing capabilities such as barcoding, storage, and/or sorting.

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
EMDN

W0104010603

AUTOMATED MYCOBATERIA MEDIA (BOTTLES)

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. (‎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
N/A
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.
N/A
The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
N/A