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The medical history includes obtaining the symptoms of pulmonary TB: productive, prolonged cough of three or more weeks, chest pain, and hemoptysis.Systemic symptoms include low grade remittent fever, chills, night sweats, appetite loss, weight loss, easy fatiguability, and production of sputum that starts out mucoid but changes to purulent. [1]
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 clinical study conducted the sensitivity of the MTB/RIF test on just 1 sputum sample was 92.2% for culture-positive TB; 98.2% for smear+ and culture-positive cases; and 72.5% for smear-negative, culture-positive cases, with a specificity of 99.2%. Sensitivity and higher specificity were slightly higher when 3 samples were tested. [10]
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).
If there is any question of active TB, sputum smears must be obtained. Therefore, any applicant might have findings grouped in this category, but still have active TB as suggested by the presence of signs or symptoms of TB, or sputum smears positive for AFB. [2] The main chest X-ray findings that can suggest inactive TB are: [2] 1.
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 ...
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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 ...