用于诊断儿童肺结核的Xpert(®) MTB/RIF检测

Xpert(®) MTB/RIF assay for the diagnosis of pulmonary tuberculosis in children.

作者信息

Singh M, Sethi G R, Mantan M, Khanna A, Hanif M

机构信息

Postgraduate Institute of Medical Education and Research, Chandigarh, India.

Department of Paediatrics, Maulana Azad Medical College, New Delhi, India.

出版信息

Int J Tuberc Lung Dis. 2016 Jun;20(6):839-43. doi: 10.5588/ijtld.15.0824.

DOI:10.5588/ijtld.15.0824

PMID:27155190

Abstract

SETTING

A tertiary care teaching hospital in New Delhi, India.

OBJECTIVE

To determine the sensitivity and specificity of the Xpert(®) MTB/RIF assay in paediatric pulmonary tuberculosis (PTB) using MGIT™ culture as gold standard.

METHODS

After ethical approval had been obtained, 50 patients aged 0-14 years with suspected PTB were enrolled. Sputum/induced sputum and gastric lavage from the participants were sent for direct smear, MGIT culture and Xpert testing. Chest X-ray and tuberculin skin test (TST) were also performed. PTB diagnosis was made without considering Xpert results according to the Revised National Tuberculosis Control Programme (RNTCP) algorithm. The sensitivity and specificity of Xpert were calculated using culture as gold standard.

RESULTS

Of 50 individuals with suspected PTB, 23 (46%) were diagnosed with PTB based on the RNTCP algorithm. Sixteen children from the PTB group (69.5%) were Xpert-positive. None in the 'not PTB' group were Xpert-positive. With culture as gold standard, Xpert sensitivity and specificity were respectively 91.6% (95%CI 59.7-99.5) and 86.8% (95%CI 71.1-95.05).

CONCLUSION

In almost 70% of PTB cases, a definitive diagnosis could be made within 2 h using Xpert, establishing its role as a sensitive and specific point-of-care test.

摘要

背景

印度新德里的一家三级护理教学医院。

目的

以MGIT™培养法作为金标准，确定Xpert® MTB/RIF检测在儿童肺结核（PTB）中的敏感性和特异性。

方法

在获得伦理批准后，纳入50例年龄在0至14岁之间疑似患有PTB的患者。将参与者的痰液/诱导痰和洗胃样本送去进行直接涂片、MGIT培养和Xpert检测。还进行了胸部X光检查和结核菌素皮肤试验（TST）。根据修订后的国家结核病控制规划（RNTCP）算法，在不考虑Xpert结果的情况下做出PTB诊断。以培养法作为金标准计算Xpert的敏感性和特异性。

结果

在50例疑似PTB的个体中，根据RNTCP算法，有23例（46%）被诊断为PTB。PTB组中有16名儿童（69.5%）Xpert检测呈阳性。“非PTB”组中无人Xpert检测呈阳性。以培养法作为金标准，Xpert的敏感性和特异性分别为91.6%（95%可信区间59.7 - 99.5）和86.8%（95%可信区间71.1 - 95.05）。