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用于快速培养确认结核分枝杆菌的Capilia TB检测法和BD ProbeTec ET系统的性能评估

Performance assessment of the Capilia TB assay and the BD ProbeTec ET system for rapid culture confirmation of Mycobacterium tuberculosis.

作者信息

Wang Jann-Yuan, Lee Li-Na, Lai Hsin-Chih, Hsu Hsiao-Leng, Jan I-Shiow, Yu Chong-Jen, Hsueh Po-Ren, Yang Pan-Chyr

机构信息

Internal Medicine, National Taiwan University Hospital, Taipei 100, Taiwan.

出版信息

Diagn Microbiol Infect Dis. 2007 Dec;59(4):395-9. doi: 10.1016/j.diagmicrobio.2007.06.010. Epub 2007 Sep 18.

Abstract

Because of the increasing numbers of nontuberculous mycobacterial isolates from clinical specimens, rapid and accurate methods for culture confirmation of Mycobacterium tuberculosis are urgently needed. The study evaluated the performance of the Capilia TB immunochromatographic assay (TAUNS, Numazu, Japan) for culture confirmation of M. tuberculosis using 242 culture-positive liquid media in 2 mycobacterial laboratories from November 2005 to February 2006. Among the 242 samples, 183 were also tested with the BD ProbeTec ET (CTB) assay (Becton Dickinson, Sparks, MD). The results of both assays were compared to the culture results and to each other. The overall sensitivity and specificity of the Capilia TB assay were 98.6% and 97.9%, respectively, and for the CTB assay were 97.3% and 97.1%, respectively. The positive and negative predictive values for the Capilia TB assay were 98.6% and 97.9%, respectively, and for the CTB assay were 98.2% and 95.8%, respectively. Among the 183 samples tested with both assays, 8 had discrepant results, including Capilia-TB-false-positive in 2, CTB-false-positive in another 2, CTB-false-negative in 2, Capilia TB-false-negative in 1, and both assays with false-negative results in the remaining one. This study demonstrated that the Capilia TB assay has a similar diagnostic value with the CTB assay. In addition, with the immunochromatographic method, it is less time-consuming and does not require other laboratory equipment.

摘要

由于临床标本中非结核分枝杆菌分离株数量不断增加,迫切需要快速、准确的结核分枝杆菌培养确认方法。该研究于2005年11月至2006年2月在2个分枝杆菌实验室中,使用242份培养阳性的液体培养基评估了Capilia TB免疫层析检测法(日本沼津TAUNS公司)用于结核分枝杆菌培养确认的性能。在这242份样本中,183份还采用BD ProbeTec ET(CTB)检测法(美国马里兰州斯帕克斯市贝克顿·迪金森公司)进行了检测。将两种检测法的结果与培养结果以及彼此之间进行了比较。Capilia TB检测法的总体灵敏度和特异性分别为98.6%和97.9%,CTB检测法的总体灵敏度和特异性分别为97.3%和97.1%。Capilia TB检测法的阳性预测值和阴性预测值分别为98.6%和97.9%,CTB检测法的阳性预测值和阴性预测值分别为98.2%和95.8%。在两种检测法均检测的183份样本中,有8份结果不一致,包括Capilia TB假阳性2份、CTB假阳性2份、CTB假阴性2份、Capilia TB假阴性1份,以及其余1份两种检测法均为假阴性结果。该研究表明,Capilia TB检测法与CTB检测法具有相似的诊断价值。此外,采用免疫层析法耗时更少,且不需要其他实验室设备。

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