Indication - Tuberculosis (TB)
Immune response by interferon-gamma release assay (IGRA)
Facility level:
Assay formats
Immunoassay or enzyme-linked immune absorbent spot (ELISpot) assay
Status history
First added in 2018
Changed in 2020
Purpose type
To diagnose latent TB infection
Specimen types
Venous whole blood
WHO prequalified or recommended products
WHO supporting documents
Latent TB Infection: updated and consolidated guidelines for programmatic management (2018) http://apps.who.int/iris/handle/10665/260233
ICD11 code: 1B1Z

Summary of SAGE IVD recommendation

The selection of the disease specific diagnostics tests for the EDL took into account the relevant priority diseases for the WHO such as HIV infection, tuberculosis, malaria, viral hepatitis B and C, syphilis and HPV infection. For these diseases there are WHO guidelines and technical reports, including recommendations for the appropriate IVDs. These documents are the result of significant evidence review and formed the basis for the inclusion of these IVDs in the EDL.

Details of submission from 2020

The inclusion of this entry was based on WHO guidelines and technical reports that include recommendations for the appropriate IVDs.