IGRA Product Profiles

Around a quarter of the global population is estimated to have been infected with Mycobacterium tuberculosis (Mtb), with 5-10% of those developing active disease during their lifetimes. Interferon Gamma Release Assays (IGRAs) are blood-based tests for Mtb infection. Unlike the tuberculin-based Mantoux skin test, IGRAs are not affected by prior BCG (bacille Calmette-Guérin) vaccination. Testing for Mtb infection before TB preventive treatment is particularly of use for people who are household contacts of people with TB or from other risk groups.

 

The interferon-gamma release assays (IGRAs) in the table below are eligible for procurement using Global Fund resources. To be eligible for procurement, IGRAs must meet at least one of the following standards: WHO policy recommendation; authorized for use by one of the Regulatory Authorities of the Founding Members of the Global Harmonization Task Force (GHTF), i.e., the regulatory authorities of the United States of America, the European Union, Japan, Canada and Australia, when stringently assessed (Class C and D); recommended for use by the Global Fund’s Expert Review Panel. 

 

Click on any IGRA below for more information. 

 

QuantiFERON-TB Gold Plus (QFT-Plus)

WANTAI TB-IGRA

STANDARD E TB-Feron ELISA

RIDAScreen TB

Type: ELISA-based

Type: ELISA-based

Type: ELISA-based

Type: ELISA-based

Approval status: WHO policy recommendation; GHTF (US FDA)

Approval status: WHO policy recommendation

Approval status: WHO policy recommendation

Approval status: GHTF (EU IVDR)

 

IGRA-TB

RIDAQuick TB

T-SPOT.TB

LIAISON QFT-Plus 

Type: Lateral Flow Fluorescence Immunoassay (FIA) with proprietary instrument

Type: Lateral Flow Immunoassay with proprietary instrument

Type: ELISPOT-based

Type: Chemiluminescence Immunoassay (CLIA) with proprietary instrument

Approval status: GHTF (EU IVDR)

 

Approval status: GHTF (EU IVDR)

Approval status: WHO policy recommendation; GHTF (US FDA)

Approval status: WHO policy recommendation; GHTF (US FDA)