Division of Tuberculosis Elimination, National Center for HIV, STD, and TB Prevention, CDC, Atlanta, GA 30333, USA.
MMWR Recomm Rep. 2010 Jun 25;59(RR-5):1-25.
n 2005, CDC published guidelines for using the QuantiFERON-TB Gold test (QFT-G) (Cellestis Limited, Carnegie, Victoria, Australia) (CDC. Guidelines for using the QuantiFERON-TB Gold test for detecting Mycobacterium tuberculosis infection, United States. MMWR;54[No. RR-15]:49-55). Subsequently, two new interferon gamma (IFN- gamma) release assays (IGRAs) were approved by the Food and Drug Administration (FDA) as aids in diagnosing M. tuberculosis infection, both latent infection and infection manifesting as active tuberculosis. 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). 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. 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. This report provides guidance to U.S. public health officials, health-care providers, and laboratory workers for use of FDA-approved IGRAs in the diagnosis of M. tuberculosis infection in adults and children. In brief, TSTs and IGRAs (QFT-G, QFT-GIT, and T-Spot) may be used as aids in diagnosing M. tuberculosis infection. They may be used for surveillance purposes and to identify persons likely to benefit from treatment. 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.
2005 年，CDC 发布了使用 QuantiFERON-TB Gold 试验（QFT-G）（Cellestis Limited，Carnegie，Victoria，Australia）（CDC. 使用 QuantiFERON-TB Gold 试验检测结核分枝杆菌感染的指南，美国。MMWR；54[No. RR-15]：49-55）的指南。随后，食品和药物管理局（FDA）批准了两种新的干扰素γ（IFN-γ）释放检测（IGRAs）作为诊断结核分枝杆菌感染（潜伏感染和活动性肺结核）的辅助手段。这些检测是 QuantiFERON-TB Gold In-Tube 检测（QFT-GIT）（Cellestis Limited，Carnegie，Victoria，Australia）和 T-SPOT.TB 检测（T-Spot）（Oxford Immunotec Limited，Abingdon，United Kingdom）。这些检测的抗原、方法和解释标准与之前 FDA 批准的 IGRAs 不同。为了协助制定与 IGRAs 使用相关的建议，CDC 召集了一组专家审查科学证据，并就 IGRAs 的使用提供意见。在编写这些指南时，使用了提交给 FDA 的数据、已发表的报告以及与 IGRAs 相关的专家意见。关于 IGRAs 的研究，其敏感性、特异性和一致性数据因所使用的检测方法不同而有所不同。尽管有关 IGRAs 的准确性及其预测后续活动性肺结核能力的数据有限，但迄今为止，涉及各种人群的研究尚未报告重大缺陷。本报告为美国公共卫生官员、医疗保健提供者和实验室工作人员提供了在成人和儿童中使用 FDA 批准的 IGRAs 诊断结核分枝杆菌感染的指导。简而言之，TST 和 IGRAs（QFT-G、QFT-GIT 和 T-Spot）可作为诊断结核分枝杆菌感染的辅助手段。它们可用于监测目的，并确定可能受益于治疗的人群。还提供了多项其他建议，涉及质量控制、检测选择和检测后的医疗管理。尽管在证明 IGRAs 的效用方面取得了重大进展，但仍需要进行更多的研究，重点关注 IGRAs 在对医疗保健或结核病控制重要的情况下的价值和局限性。列出了需要进一步研究的具体领域。
