Use of alternative interferon-gamma release assays for the diagnosis of TB infection - WHO Policy Statement

Following review of evidence and advice from the Technical Advisory Group (TAG) on Tuberculosis (TB) Diagnostics and Laboratory Strengthening, the World Health Organization (WHO) announces that current WHO recommendations for the use of interferon-gamma release assays (IGRA) are also valid for Beijing Wantai's TB-IGRA and Qiagen QuantiFERON-TB Gold Plus products. This expands the range of tests available to detect TB infection. Full details are provided in the WHO policy statement.

A quarter of the world's population is estimated to be infected with Mycobacterium tuberculosis. Testing for TB infection increases the probability that individuals who are identified for preventive treatment will benefit from such treatment. Two classes of tests - tuberculin skin test (TST) and interferon-gamma release assay (IGRA) - are currently recommended by WHO to test for TB infection. The policy statement adds two products to the options available in the IGRA class of tests.

The guidance provided should facilitate the procurement and uptake of the recommended technologies and improve patient care. The current WHO recommendations on the use of TST and IGRAs (including T-SPOT.TB) are unchanged and remain valid. WHO recommendations on diagnostics are based on clinical research evidence - they do not include quality assessments of the products or manufacturing process involved, which require regulatory processes.