Comparison of the sensitivity and specificity of two whole blood interferon-gamma assays for M-tuberculosis infection
Comparison of the sensitivity and specificity of two whole blood interferon-gamma assays for M-tuberculosis infection
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DOI：
10.1016/j.jinf.2008.02.011
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发表时间：
2008-05-01
影响因子：
28.2
通讯作者：
Ishikawa, Nobukatsu
中科院分区：
文献类型：
--
作者：
Harada, Nobuyuki;Higuchi, Kazue;Ishikawa, Nobukatsu
目的：比较 QuantiFERON (R)-TB Gold (QFT-G) 和 QuantiFERON (R)-TB Gold In Tube (QFT-GIT) 结核分枝杆菌感染诊断测试的敏感性和特异性。方法：对 100 名经培养和/或 PCR 确诊结核分枝杆菌感染的患者和 168 名没有结核分枝杆菌感染危险因素的志愿者进行测试，分别评估敏感性和特异性。结果：对具有有效结果的结核病 (TB) 患者的数据进行分析发现，QFT-GIT 的敏感性 (92.6%, 87/94) 显着高于 QFT-G 测试 (81.4%,79/97；p = 0.023)。 QFT-GIT 和 QFT-G 的特异性均为 98.8%（CI：95.1%-99.8%），160 名低风险受试者中有 2 名两项测试的有效结果均为阳性。数据分析证实了制造商推荐的测试截止值是最佳的，但发现使用较低的截止值可以获得更高的灵敏度，而特异性仅略有下降。结论：与 QFT-G 测试相比，QFT-GIT 测试在检测结核分枝杆菌感染方面具有更高的灵敏度，同时保持同等的高特异性。 QFT-GIT 检测形式的后勤优势及其更高的灵敏度应该能够增强结核病控制。 (c) 2008 年英国感染学会。由爱思唯尔有限公司出版。保留所有权利。
Objectives: To compare the sensitivity and the specificity of the QuantiFERON (R)-TB Gold (QFT-G) and QuantiFERON (R)-TB Gold In Tube (QFT-GIT) diagnostic tests for Mycobacterium tuberculosis infection.Methods: One-hundred patients with culture and/or PCR confirmed M. tuberculosis infection and 168 volunteers with no risk factors for M. tuberculosis infection were tested to estimate sensitivity and specificity, respectively.Results: Analysis of data from the tuberculosis (TB) patients with valid results found the sensitivity of QFT-GIT (92.6%, 87/94) to be significantly higher than that for the QFT-G test (81.4%,79/97; p = 0.023). The specificity of both QFT-GIT and QFT-G was 98.8% (CI: 95.1%-99.8%) with 2 of the 160 tow risk subjects with valid results for both tests being positive. Data analysis confirmed the manufacturer's recommended test cut-off as being optimal, but identified higher sensitivity could be obtained by using a lower cut-off, with only a moderate decrease in specificity.Conclusions: The QFT-GIT test had enhanced sensitivity for detection of M. tuberculosis infection over the QFT-G test, whilst maintaining equivalent high specificity. The logistic benefits of the QFT-GIT test format, as well as its higher sensitivity, should enable enhanced TB control. (c) 2008 The British Infection Society. Published by Elsevier Ltd. All rights reserved.