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IGRAs cannot distinguish between latent infection and active tuberculosis (TB) disease, and should not be used as a sole method for diagnosis of active TB, which is a microbiological diagnosis. A positive IGRA result may not necessarily indicate TB infection, but can also be caused by infection with non-tuberculous mycobacteria.
T-SPOT.TB, a form of ELISpot, the variant of ELISA (licensed in Europe, US, Japan and China). [3] 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.
A meta-analysis with 1,595 inpatients and outpatients showed 70% sensitivity and 90% specificity for TB diagnosis in people living with HIV for Fujifilm SILVAMP TB LAM. [40] As of 2020, the test showed a high positive predictive value (95.2%) in HIV-negative outpatients. [41] Large prospective studies are on the way. [42]
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The results of this test must be interpreted carefully. The person's medical risk factors determine at which increment (5 mm, 10 mm, or 15 mm) of induration the result is considered positive. [12] A positive result indicates TB exposure. 5 mm or more is positive in An HIV-positive person; Persons with recent contacts with a TB patient
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. TB may in fact be worse than that of the tuberculin skin test (sensitivity reported as 66% and 82%, respectively). [ 4 ]
In Bangladesh, Cambodia, and Indonesia, there is a diagnostic treatment for latent tuberculosis in children below five years of age. The IGRA approach (Interferon Gamma Release Assay) is used in these countries. IGRA testing and diagnosis are whole blood cell tests where fresh blood samples are mixed with antigens and controls.
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