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Tuberculosis Epidemiologic Studies Consortium (TBESC)Task Order 18: Evaluation of new interferon-gamma release assays in the diagnosis of LTBI in healthcare workersTask Order 18 seeks to evaluate the test characteristics, feasibility, and cost-effectiveness of interferon-gamma release assays (IGRAs) and the tuberculin skin test (TST) when testing for latent tuberculosis infection (LTBI) in healthcare workers (HCWs). SitesCharles P. Felton National TB Center at Harlem, Denver Public Health and Hospitals Authority, Maryland Department of Health and Mental Hygiene, and Texas Department of State Health Services. Study Objectives
Study DesignThis study will compare three testing methods for latent tuberculosis infection (LTBI) in Healthcare workers who are tested serially. The three methods are: TST with an initial two-step assessment, QFT-G test (in-tube) and T-Spot TB test. After providing written consent, the Healthcare worker will undergo a standardized interview, have a TST placed, and have at least 30ml of blood drawn. A TST will be placed (Tubersol, 5 TU PPD), read, and interpreted by trained individuals. Two-step testing will be performed on healthcare workers who have initial negative TST result. The IGRAs will be repeated with the TST so three tubes of blood will be obtained at each visit. For healthcare workers who have two-step testing, two IGRAs will be repeated with the TST to observe whether the initial TST influences results from the IGRAs. The influence of treating LTBI will be studied by comparing longitudinal test results in healthcare workers who do and do not receive treatment. Direct and indirect costs will be calculated for each test method for comparing costs for each strategy and determining cost-effectiveness. The acceptability and usability of the IGRAs by providers and the acceptability of the testing procedures by the patients will be assessed using qualitative methodology such as standardized questionnaires and key informant interviews with providers and patients recruited from the participating sites. Study ProgressTO 18’s study protocol, consent form, and questionnaires have been developed and submitted to CDC IRB. Piloting is expected to begin in August 2007. Last Modified: 07/25/2007 Last Reviewed: 05/18/2008 |
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Centers for Disease Control & Prevention |