#CDC UPDATED GUIDELINES SKIN#

public health officials, health-care providers, and laboratory workers for use of FDA-approved IGRAs in the diagnosis of M. This report provides updated guidance to U.S. Updated IGRA guidelines are needed because since 2005, two new IGRAs have been approved by FDA, and several hundred peer-reviewed articles describing clinical studies of IGRAs have been published. CDC published guidelines for using QFT in 2003 and for using QFT-G in 2005 ( 6, 8). In 2005, the QuantiFERON-TB Gold test (QFT-G) (Cellestis Limited, Carnegie, Victoria, Australia) became the second IGRA approved by FDA as an aid for diagnosing M. In 2001, the QuantiFERON-TB test (QFT) (Cellestis Limited, Carnegie, Victoria, Australia) became the first IGRA approved by the Food and Drug Administration (FDA) as an aid for diagnosing M. tuberculosis by measuring IFN-γ release in response to antigens representing M. tuberculosis infection led to development of interferon gamma release assays (IGRAs) for the detection of M. Recognition that interferon gamma (IFN-γ) plays a critical role in regulating cell-mediated immune responses to M.

#CDC UPDATED GUIDELINES SKIN#

Introductionīefore 2001, the tuberculin skin test (TST) was the only practical and commercially available immunologic test for Mycobacterium tuberculosis infection approved in the United States ( 1). Specific areas needing additional research are listed. Multiple additional recommendations are provided that address quality control, test selection, and medical management after testing.Īlthough substantial progress has been made in documenting the utility of IGRAs, additional research is needed that focuses on the value and limitations of IGRAs in situations of importance to medical care or tuberculosis control.

They may be used for surveillance purposes and to identify persons likely to benefit from treatment. In brief, TSTs and IGRAs (QFT-G, QFT-GIT, and T-Spot) may be used as aids in diagnosing M. tuberculosis infection in adults and children. Although data on the accuracy of IGRAs and their ability to predict subsequent active tuberculosis are limited, to date, no major deficiencies have been reported in studies involving various populations.

Results of studies examining sensitivity, specificity, and agreement for IGRAs and TST vary with respect to which test is better. Data submitted to FDA, published reports, and expert opinion related to IGRAs were used in preparing these guidelines. The antigens, methods, and interpretation criteria for these assays differ from those for IGRAs approved previously by FDA.įor assistance in developing recommendations related to IGRA use, CDC convened a group of experts to review the scientific evidence and provide opinions regarding use of IGRAs. These tests are the QuantiFERON-TB Gold In-Tube test (QFT-GIT) (Cellestis Limited, Carnegie, Victoria, Australia) and the T-SPOT.TB test (T-Spot) (Oxford Immunotec Limited, Abingdon, United Kingdom). tuberculosis infection, both latent infection and infection manifesting as active tuberculosis. Subsequently, two new interferon gamma (IFN- γ ) release assays (IGRAs) were approved by the Food and Drug Administration (FDA) as aids in diagnosing M. Guidelines for using the QuantiFERON-TB Gold test for detecting Mycobacterium tuberculosis infection, United States. Telephone: 40 Fax: 40 E-mail: 2005, CDC published guidelines for using the QuantiFERON-TB Gold test (QFT-G) (Cellestis Limited, Carnegie, Victoria, Australia) (CDC. Mazurek, MD, Division of Tuberculosis Elimination, National Center for HIV, STD, and TB Prevention, CDC, 1600 Clifton Rd., N.E., MS E-10, Atlanta, GA 30333.

Castro, MD, Director.Ĭorresponding preparer: Gerald H. The material in this report originated in the National Center for HIV, STD, and TB Prevention, Kevin Fenton, MD, PhD, Director and the Division of Tuberculosis Elimination, Kenneth G. Mazurek, MD, John Jereb, MD, Andrew Vernon, MD, Phillip LoBue, MD, Stefan Goldberg, MD, Kenneth Castro, MDĭivision of Tuberculosis Elimination, National Center for HIV, STD, and TB Prevention, CDC

Cdc updated guidelines