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The device, as modified, will be marketed under the trade name quantiferon-tb gold in-tube and is indicated for use as an in vitro diagnostic test using a peptide cocktail simulating esat-6, cfp-10 and tb 7.7(p4) proteins to stimulate cells in heparinized whole blood drawn directly into specialized blood collection tubes.
QuantiFERON-TB Gold is FDA-approved in the United States, has CE Mark approval in Europe and has been approved by the MHLW in Japan. The interferon gamma release assay is the preferred method for patients who have had immunosuppression and are about to start biological therapies. [27] T-SPOT.TB is another IGRA; it uses the ELISPOT method ...
In a recently published metaanalysis, [26] with data from both developed and developing countries, QuantiFERON-TB Gold In Tube had a pooled sensitivity for active TB of 81% and specificity of 99.2%, whereas T-SPOT.TB had a pooled sensitivity of 87.5% and specificity of 86.3%. In head-to-head comparisons, the sensitivity of IGRAs surpassed TST.
The equivalent Mantoux test positive levels done with 10 TU (0.1 mL 100 TU/mL, 1:1000) are . 0–4 mm induration (Heaf 0-1) 5–14 mm induration (Heaf 2) >15 mm induration (Heaf 3-4)
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T-SPOT.TB counts the number of antimycobacterial effector T cells, white blood cells that produce interferon-gamma, in a sample of blood.This gives an overall measurement of the host immune response against mycobacteria, which can reveal the presence of infection with Mycobacterium tuberculosis, the causative agent of tuberculosis (TB).
The tine test is a multiple-puncture tuberculin skin test used to aid in the medical diagnosis of tuberculosis (TB). The tine test is similar to the Heaf test, although the Mantoux test is usually used instead. There are various forms of the tine tests which usually fall into two categories: the old tine test (OT) and the purified protein ...
Multiple US agencies rolled out new public health rules as a result of the TB spread: the CDC brought in new guidelines mandating HEPA filters and HEPA respirators, [127] NIOSH pushed through new 42 CFR 84 respirator regulations in 1995 (like the N95), [128] and OSHA created a proposed rule for TB in 1997, a result of pressure from groups like ...