多中心研究 QuantiFERON-TB Gold Plus 在活动性肺结核患者中的应用。
Multicenter study of QuantiFERON-TB Gold Plus in patients with active tuberculosis.
机构信息
Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Department of Global Health, Firland Northwest TB Center, University of Washington, Seattle, Washington.
Division of Infectious Diseases, Department of Medicine, University of Southern California, Los Angeles, California, USA.
出版信息
Int J Tuberc Lung Dis. 2018 Jun 1;22(6):617-621. doi: 10.5588/ijtld.17.0721.
SETTING
QuantiFERON®-TB Gold Plus (QFT-Plus), recently approved for use in the United States, is a new-generation QuantiFERON assay that differs from its predecessors in that it uses an additional antigen tube containing peptides to elicit both CD8+ and CD4+ T-lymphocyte responses.
OBJECTIVE
To assess the sensitivity of QFT-Plus compared with QuantiFERON®-TB Gold In-Tube (QFT-GIT) in participants with active TB.
DESIGN
Adult patients with active TB at three US and two Japanese sites were eligible for this study if they had culture-confirmed TB and were either untreated or had received 14 days of anti-tuberculosis treatment.
RESULTS
We enrolled 164 participants, nine of whom had indeterminate results. Excluding indeterminate values, there were 150 QFT-GIT-positive results among 159 tests and 146 QFT-Plus-positive results among 157 tests, with sensitivities of respectively 94.3% (95%CI 89.5-97.4) and 93.02% (95%CI 87.8-96.5%). The estimated sensitivities for the two tests were not significantly different (P = 0.16). Overall test agreement was 98.7%, with a κ statistic of 0.89 (95%CI 0.75-1.00).
CONCLUSION
In this multisite study, we found that QFT-Plus had similar sensitivity to QFT-GIT in adult patients with active TB.
背景
QuantiFERON-TB Gold Plus（QFT-Plus）最近在美国获得批准使用，是一种新一代的 QuantiFERON 检测方法，与前几代产品不同，它使用含有肽的额外抗原管来引发 CD8+和 CD4+T 淋巴细胞反应。
目的
评估 QFT-Plus 与 QuantiFERON-TB Gold In-Tube（QFT-GIT）在活动性结核病患者中的敏感性。
设计
在美国和日本的三个和两个地点，如果患者有培养确认的结核病，且未接受治疗或接受了 14 天的抗结核治疗，符合条件的活动性结核病成人患者可参与本研究。
结果
我们共纳入了 164 名参与者，其中 9 名结果不确定。排除不确定值后，在 159 次 QFT-GIT 检测中有 150 次阳性结果，在 157 次 QFT-Plus 检测中有 146 次阳性结果，其敏感性分别为 94.3%（95%CI 89.5-97.4）和 93.02%（95%CI 87.8-96.5%）。两种检测方法的敏感性估计值无显著差异（P = 0.16）。总的检测一致性为 98.7%，κ 统计量为 0.89（95%CI 0.75-1.00）。
结论
在这项多中心研究中，我们发现 QFT-Plus 在活动性结核病的成年患者中与 QFT-GIT 具有相似的敏感性。
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