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[1084例结核病疑似患者T-SPOT.TB检测的临床评估]

[Clinical evaluation of T-SPOT. TB assay in 1 084 tuberculosis suspects].

作者信息

Liu Hong, Huang Yongjie, Wang Jing, Ni Ran, Zhang Zhao, Guo Xinzhi, Zhao Xin

机构信息

Department of Respiratory and Critical Care Medicine, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.

Department of Laboratory Medicine, Beijing Hospital, Beijing 100730, China. Email:

出版信息

Zhonghua Jie He He Hu Xi Za Zhi. 2014 Mar;37(3):192-6.

PMID:24809710
Abstract

OBJECTIVE

To evaluate the T-SPOT. TB assay for the diagnosis of tuberculosis in a large clinical samples.

METHODS

We analyzed the T-SPOT. TB results of 1 084 tuberculosis (TB) suspects who were admitted to the First Affiliated Hospital of Zhengzhou University from February 2011 to October 2011. The sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio of T-SPOT. TB were analyzed according to the final diagnosis. Among these patients, 60 were retested by T-SPOT. TB after 2-4 week anti-tuberculosis treatment, and spot forming cells (SFCs) were compared before and after treatment. Paired t-test was used for comparison between groups.

RESULTS

Three hundred and eighty-four patients were eventually diagnosed to have TB. Among 54 patients with laboratory diagnosis of TB, 42 were T-SPOT. TB positive, and the sensitivity was 77.8% (42/54). In 330 cases clinically diagnosed as tuberculosis, 289 were T-SPOT. TB positive, and the sensitivity was 87.6% (289/330). The total sensitivity of T-SPOT. TB was 86.2% (331/384). In 700 non-TB patients, 638 cases were T-SPOT. TB negative, and the specificity was 91.1% (638/700). The positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio were 84.2% (331/393), 92.3% (638/691), 9.69 and 0.15, respectively. Sixty patients were retested by the T-SPOT. TB after anti-TB treatment (2-4 weeks), and the results showed that both ESAT-6 and CFP-10 specific SFCs (47 and 18, respectively) decreased significantly compared with those before anti-TB treatment (99 and 49, respectively).

CONCLUSION

in this large scale study indicate that T-SPOT. TB is a promising test for the diagnosis of tuberculosis due to its high sensitivity and specificity.

摘要

目的

评估T-SPOT.TB检测在大量临床样本中诊断结核病的价值。

方法

分析2011年2月至2011年10月入住郑州大学第一附属医院的1084例疑似结核病患者的T-SPOT.TB检测结果。根据最终诊断分析T-SPOT.TB的敏感性、特异性、阳性预测值、阴性预测值、阳性似然比、阴性似然比。其中60例患者在抗结核治疗2-4周后再次进行T-SPOT.TB检测,比较治疗前后的斑点形成细胞(SFC)数量。组间比较采用配对t检验。

结果

最终确诊384例结核病患者。在54例实验室确诊的结核病患者中,42例T-SPOT.TB检测阳性,敏感性为77.8%(42/54)。在330例临床诊断为结核病的患者中,289例T-SPOT.TB检测阳性,敏感性为87.6%(289/330)。T-SPOT.TB的总敏感性为86.2%(331/384)。在700例非结核病患者中,638例T-SPOT.TB检测阴性,特异性为91.1%(638/700)。阳性预测值、阴性预测值、阳性似然比和阴性似然比分别为84.2%(331/393)、92.3%(638/691)、9.69和0.15。60例患者在抗结核治疗(2-4周)后再次进行T-SPOT.TB检测,结果显示与抗结核治疗前相比,ESAT-6和CFP-10特异性SFC数量(分别为47和18)显著减少(治疗前分别为99和49)。

结论

在这项大规模研究中表明,T-SPOT.TB因其高敏感性和特异性,是一种很有前景的结核病诊断检测方法。

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