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Disease/health condition - Tuberculosis (TB)
Interferon-gamma release assay (IGRA)
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
Immunoassay
Information History
First added in 2018
Changed in 2024
Purpose type
Treatment selection
Purpose
To aid in the detection of TB infection. To support the decision of initiating tuberculosis preventive treatment.
Specimen types
Venous whole blood
WHO prequalified or recommended products
Products recommended by WHO/GTB will also undergo WHO PQ assessment.
GMDN

60744

Interferon gamma release IVD, kit, enzyme immunoassay (EIA)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of interferon gamma (IFN gamma) released in response to T-cell activation resulting from stimulation by one or multiple specific antigens or mitogens, using an enzyme immunoassay (EIA) method. It is typically used as an indirect marker of infection for (but not limited to) Borrelia species, Epstein-Barr virus (EBV), Cytomegalovirus (CMV), BK virus, severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), and/or Mycobacterium species.

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

W0105010704

TB-IGRA (INTERFERON--GAMMA--RELEASE ASSAY)

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 A: information sheets, 3rd ed. World Health Organization. https://iris.who.int/handle/10665/376284
Technical specifications
N/A
Related Medical Devices in MeDevIS
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.
N/A