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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 ...
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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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.
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Effective TB treatment is difficult, due to the unusual structure and chemical composition of the mycobacterial cell wall, which hinders the entry of drugs and makes many antibiotics ineffective. [137] Active TB is best treated with combinations of several antibiotics to reduce the risk of the bacteria developing antibiotic resistance. [14]