29 November, 2022 – Geneva, Switzerland - The Stop TB Partnership today released a Manual on selection and use of interferon-gamma release assays (IGRAs) for testing for TB infection, developed jointly with the United States Agency for International Development (USAID) and endorsed by the Global Laboratory Initiative (GLI). The manual provides an overview of the recommended use of IGRAs as a class of in-vitro tests for the detection of TB infection and describes their performance, steps for use and implementation considerations.
The scope of the manual includes specific IGRAs that are either approved by the WHO Global TB Programme or the Global Fund’s Expert Review Panel for Diagnostics, including QuantiFERON®-TB Gold Plus (QIAGEN GmbH, Hilden, Germany), T-SPOT®.TB (Oxford Immunotec Ltd, Abingdon, UK), WANTAI TB-IGRA (Beijing WANTAI Biological Pharmacy Enterprise Co., Ltd, Beijing, China) and StandardTM E TB-Feron ELISA (SD Biosensor, Gyeonggi-do, Republic of Korea).
“I warmly welcome the release of this technical manual which can guide countries on decision-making around adoption of IGRAs and reflects clear commitment by global stakeholders to step up and scale up TB prevention measures,” said Dr. Lucica Ditiu, Executive Director of the Stop TB Partnership.
The Stop TB Partnership’s Global Plan to End TB 2023-2030 calls for priority actions to rapidly scale-up TB prevention, to allow for 35 million people to access TB preventive treatment (TPT) by 2030. The Global Plan describes how new technologies including IGRAs as well as Mycobacterium tuberculosis antigen-based skin tests recently recommended by WHO can accurately select people who will benefit from TPT, and countries should scale-up a “test-and-treat” approach for TPT as infection testing technology advances and allows for more decentralized testing.
The manual will be periodically updated as additional tests become approved. The QIAreach® QuantiFERON®-TB, a near point-of-care IGRA, has been approved by the Global Fund’s Expert Review Panel for Diagnostics, however QIAGEN has paused its commercialization.