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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.
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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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 ...
Drug-resistant TB is a serious public health issue in many developing countries, as its treatment is longer and requires more expensive drugs. MDR-TB is defined as resistance to the two most effective first-line TB drugs: rifampicin and isoniazid.
Tube cap color or type in order of draw Additive Usage and comments Blood culture bottle: Sodium polyanethol sulfonate (anticoagulant) and growth media for microorganisms: Usually drawn first for minimal risk of contamination. [1] Two bottles are typically collected in one blood draw; one for aerobic organisms and one for anaerobic organisms ...
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).