Guidelines for using the QuantiFERON-TB Gold test for detecting Mycobacterium tuberculosis infection, United States.

On May 2, 2005, a new in vitro test, QuantiFERON®-TB Gold (QFT-G, Cellestis Limited, Carnegie, Vi Australia), received final approval from the U.S. Food and Drug Administration as an aid for diagnosin Mycobacterium tuberculosis infection. This test detects the release of interferon-gamma (IFN-g) in fres heparinized whole blood from sensitized persons when it is incubated with mixtures of synthetic peptide representing two proteins present in M. tuberculosis: early secretory antigenic target--6 (ESAT-6) and c filtrate protein--10 (CFP-10). These antigens impart greater specificity than is possible with tests using protein derivative as the tuberculosis (TB) antigen. In direct comparisons, the sensitivity of QFT-G was statistically similar to that of the tuberculin skin test (TST) for detecting infection in persons with untrea culture-confirmed tuberculosis (TB). The performance of QFT-G in certain populations targeted by TB programs in the United States for finding latent TB infection is under study. Its ability to predict who ev will have TB disease has not been determined, and years of observational study of substantial populatio be needed to acquire this information. In July 2005, CDC convened a meeting of consultants and resear expertise in the field to review scientific evidence and clinical experience with QFT-G. On the basis of t and discussion, CDC recommends that QFT-G may be used in all circumstances in which the TST is cu used, including contact investigations, evaluation of recent immigrants, and sequential-testing surveilla Page 1 of 10 Guidelines for Using the QuantiFERON ® -TB Gold Test for Detecting

Keywords:

• Mycobacterium tuberculosis
• Interferon gamma release assay
• T-SPOT.TB
• Disease
• Tuberculin
• Antigen
• Tuberculosis
• QuantiFERON
• Medicine
• Internal medicine
• Infection control
• Tuberculosis diagnosis

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