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The Quantiferon-TB Gold test (QFT-G) is a whole-blood test for use as an aid in diagnosing Mycobacterium tuberculosis infection, including latent tuberculosis infection (LTBI) and tuberculosis (TB) disease. [15] This test was approved by the U.S. Food and Drug Administration (FDA) in 2005.
As of 6 August 2012, the cost of a test cartridge in countries eligible for concessional pricing is $9.98 USD. [ 11 ] [ 12 ] [ 13 ] As of 30 June 2013, 1,402 GeneXpert systems (comprising 7553 modules) and >3 million Xpert MTB/RIF cartridges had been procured in 88 of the 145 countries under concessional pricing.
As of 2003, the enzyme-linked immunospot assay (ELISPOT) has been another blood test available in the UK that may replace the skin test for diagnosis. [ 20 ] [ 21 ] [ 22 ] T-SPOT.TB , [ 23 ] a type of ELISpot Assay , [ 24 ] counts the number of activated T lymphocytes that secrete interferon γ.
The former test quantitates the amount of IFN-γ produced in response to the ESAT-6 and CFP-10 antigens from Mycobacterium tuberculosis, which are distinguishable from those present in BCG and most other non-tuberculous mycobacteria. The latter test determines the total number of individual effector T cells expressing IFN-γ. [citation needed]
In one study in Germany, 70 out of 72 patients with confirmed TB infection were T-SPOT.TB positive, indicating a sensitivity of 97.2%. [3] However, more recent data from a study in children with active TB disease in the UK suggest that the sensitivity of the T-SPOT.
"Guidelines for using the QuantiFERON-TB test for diagnosing latent Mycobacterium tuberculosis infection". Morbidity and Mortality Weekly Report . 52 (RR–2): 15– 18.