Performance evaluation of the Xpert MTB/RIF assay according to its clinical application.
Performance evaluation of the Xpert MTB/RIF assay according to its clinical application.
复制标题
DOI：
10.1186/s12879-014-0589-x
复制
发表时间：
2014-11-14
影响因子：
3.7
通讯作者：
Lee NY
中科院分区：
文献类型：
--
作者：
Huh HJ;Jeong BH;Jeon K;Koh WJ;Ki CS;Lee NY
Xpert MTB/RIF检测试剂盒（Xpert检测试剂盒; Cepheid，桑尼维尔，CA）正在成为结核病和利福平（RIF）耐药性快速诊断的首选检测试剂。本研究的目的是评价Xpert Assay在韩国一家三级医疗医院临床应用方面的性能，韩国是一个中等结核病负担和高资源的国家。回顾性审查了109份涂片阳性和194份涂片阴性呼吸道标本的303份Xpert检测结果。根据患者的病历，确定了Xpert检测试剂盒的4类临床应用：（1）根据临床和影像学特征，对肺结核可能性高的患者进行肺结核诊断;（2）对肺结核临床不确定患者进行结核排除;（3）在涂片阳性标本中区分结核分枝杆菌（MTB）与非结核分枝杆菌;（4）诊断RIF耐药性。标准培养和药敏试验用作参考方法。Xpert检测试剂盒检测1类结核分枝杆菌的灵敏度为89.8%（95%置信区间[CI]，78.5-95.8%），但检测2类结核分枝杆菌的灵敏度为66.7%（95% CI，12.5-98.2%）。阳性预测值范围为第2类的33.3%（95% CI，6.0-75.9%）至第1类和第3类的91.3%和91.7%。所有类别的阴性预测值均超过90%。Xpert检测试剂盒正确检出了6/7株（85.7%）供试分离株的RIF耐药性。根据其临床应用，Xpert检测试剂盒表现出不同的性能;这一发现提醒人们，需要根据其预期用途对该检测试剂盒的结果进行仔细解读。本文的在线版本（doi：10.1186/s12879-014-0589-x）包含补充材料，可供授权用户使用。
The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunnyvale, CA) is becoming the test of choice for the rapid diagnosis of tuberculosis and rifampin (RIF) resistance. The aim of this study was to evaluate the performance of the Xpert assay with respect to its clinical application at a tertiary care hospital in Korea, a country with an intermediate tuberculosis burden and high-resource. A total of 303 Xpert assay results from 109 smear-positive and 194 smear-negative respiratory specimens were retrospectively reviewed. Based on patients’ medical records, four categories of clinical applications of the Xpert assay were identified: (1) the diagnosis of pulmonary tuberculosis in patients with a high probability of pulmonary tuberculosis according to their clinical and radiological features; (2) the exclusion of tuberculosis in clinically indeterminate patients for pulmonary tuberculosis; (3) the differentiation of Mycobacterium tuberculsosis (MTB) from nontuberculous mycobacteria in a smear-positive specimen; and (4) the diagnosis of RIF resistance. Standard culture and drug susceptibility tests were used as reference methods. The sensitivity of the Xpert assay for MTB detection in category 1 was 89.8% (95% confidence interval [CI], 78.5-95.8%), but 66.7% (95% CI, 12.5-98.2%) in category 2. The positive predictive values ranged from 33.3% (95% CI, 6.0-75.9%) in category 2 to 91.3% and 91.7% in categories 1 and 3, respectively. The negative predictive values were over 90% in all categories. The Xpert assay correctly detected RIF resistance in six of the seven (85.7%) isolates tested. The Xpert assay exhibited variable performance according to its clinical application; this finding cautions that careful interpretation for the results of this assay would be needed according to its intended purpose. The online version of this article (doi:10.1186/s12879-014-0589-x) contains supplementary material, which is available to authorized users.
登录
查看更多内容
影响因子：
--
作者：
Lee, Sang Kook;Lee, Eun Ja;Kang, Young Ae
通讯作者：
Kang, Young Ae
影响因子：
9.4
作者：
Banada, Padmapriya P.;Sivasubramani, Satheesh K.;Alland, David
通讯作者：
Alland, David
影响因子：
11.8
作者：
Lippincott, Christopher K.;Miller, Melissa B.;Van Rie, Annelies
通讯作者：
Van Rie, Annelies
DOI：
10.1016/s0732-8893(00)00200-5
发表时间：
2000-12-01
影响因子：
2.9
作者：
Ahmad, S;Araj, GF;Mustafa, AS
通讯作者：
Mustafa, AS
影响因子：
9.4
作者：
Deggim, Vanessa;Somoskovi, Akos;Bloemberg, Guido V.
通讯作者：
Bloemberg, Guido V.