Mazurek, MD, John Jereb, MD, Andrew Vernon, MD, Phillip Lo Bue, MD, Stefan Goldberg, MD, Kenneth Castro, MD Division of Tuberculosis Elimination, National Center for HIV, STD, and TB Prevention, CDC The material in this report originated in the National Center for HIV, STD, and TB Prevention, Kevin Fenton, MD, Ph D, Director; and the Division of Tuberculosis Elimination, Kenneth G. Guidelines for using the Quanti FERON-TB Gold test for detecting Mycobacterium tuberculosis infection, United States. tuberculosis infection, both latent infection and infection manifesting as active tuberculosis.
Mazurek, MD, Division of Tuberculosis Elimination, National Center for HIV, STD, and TB Prevention, CDC, 1600 Clifton Rd., N. Telephone: 404-639-8174; Fax: 404-639-8961; E-mail: gym6@ In 2005, CDC published guidelines for using the Quanti FERON-TB Gold test (QFT-G) (Cellestis Limited, Carnegie, Victoria, Australia) (CDC. Subsequently, two new interferon gamma (IFN- γ) release assays (IGRAs) were approved by the Food and Drug Administration (FDA) as aids in diagnosing M.
These tests are the Quanti FERON-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).
The antigens, methods, and interpretation criteria for these assays differ from those for IGRAs approved previously by FDA.
For 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.
Data submitted to FDA, published reports, and expert opinion related to IGRAs were used in preparing these guidelines.
Results of studies examining sensitivity, specificity, and agreement for IGRAs and TST vary with respect to which test is better. public health officials, health-care providers, and laboratory workers for use of FDA-approved IGRAs in the diagnosis of M. In brief, TSTs and IGRAs (QFT-G, QFT-GIT, and T-Spot) may be used as aids in diagnosing M. They may be used for surveillance purposes and to identify persons likely to benefit from treatment.
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. Multiple additional recommendations are provided that address quality control, test selection, and medical management after testing.
Although 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.
Specific areas needing additional research are listed.
Before 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).