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评价 Xpert MTB/RIF 检测在乌干达儿童肺结核诊断中的应用:一项横断面诊断研究。

Evaluation of the Xpert MTB/RIF test for the diagnosis of childhood pulmonary tuberculosis in Uganda: a cross-sectional diagnostic study.

机构信息

Department of Paediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.

出版信息

BMC Infect Dis. 2013 Mar 12;13:133. doi: 10.1186/1471-2334-13-133.

DOI:10.1186/1471-2334-13-133
PMID:23497044
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3602671/
Abstract

BACKGROUND

The diagnosis of childhood tuberculosis remains a challenge worldwide. The Xpert MTB/RIF test, a rapid mycobacteria tuberculosis diagnostic tool, was recommended for use in children based on data from adult studies. We evaluated the performance of the Xpert MTB/RIF test for the diagnosis of childhood pulmonary tuberculosis using one induced sputum sample and described clinical characteristics associated with a positive Xpert MTB/RIF test. The sputum culture on both Lowenstein-Jensen (LJ) and Mycobacteria Growth Indicator Tube (MGIT) was the gold standard.

METHODS

We consecutively enrolled 250 Ugandan children aged 2 months to 12 years with suspected pulmonary tuberculosis between January 2011 and January 2012 into a cross-sectional diagnostic study at a tertiary care facility in Uganda.

RESULTS

We excluded data from 15 children (13 contaminated culture and 2 indeterminate MTB/RIF test results) and analysed 235 records. The Xpert MTB/RIF test had a sensitivity of 79.4% (95% CI 63.2 - 89.7) and a specificity of 96.5% (95% CI 93 - 98.3). The Xpert MTB/RIF test identified 13 of the 14 (92.9%) smear positive-culture positive and 14 of the 20 (70%) smear negative -culture positive cases. The Xpert MTB/RIF identified twice as many cases as the smear microscopy (79.4% Vs 41.2%). Age > 5 years (OR 3.3, 95% CI 1.4 - 7.4, p value 0.005), a history of Tuberculosis (TB) contact (OR 2.4, 95% CI 1.1 - 5.2, p value 0.03), and a positive tuberculin skin test (OR 4.1, 95% CI 1.7 - 10, p value 0.02) was associated with a positive Xpert MTB/RIF test. The median time to TB detection was 49.5 days (IQR 38.4-61.2) for LJ, and 6 days (IQR 5 - 11.5) for MGIT culture and 2 hours for the Xpert MTB/RIF test.

CONCLUSION

The Xpert MTB/RIF test on one sputum sample rapidly and correctly identified the majority of children with culture confirmed pulmonary tuberculosis with high specificity.

摘要

背景

儿童结核病的诊断仍然是一个全球性的挑战。Xpert MTB/RIF 检测是一种快速分枝杆菌结核诊断工具,其在儿童中的应用基于成人研究的数据。我们评估了使用一份诱导痰样本诊断儿童肺结核的 Xpert MTB/RIF 检测的性能,并描述了与 Xpert MTB/RIF 检测阳性相关的临床特征。痰培养的金标准是 Lowenstein-Jensen(LJ)和分枝杆菌生长指示管(MGIT)。

方法

我们连续纳入了 2011 年 1 月至 2012 年 1 月在乌干达一家三级医疗机构接受疑似肺结核的 250 名 2 个月至 12 岁的乌干达儿童,进行横断面诊断研究。

结果

我们排除了 15 名儿童的数据(13 名培养物污染和 2 名 MTB/RIF 检测结果不确定),并分析了 235 份记录。Xpert MTB/RIF 检测的敏感性为 79.4%(95%CI 63.2-89.7),特异性为 96.5%(95%CI 93-98.3)。Xpert MTB/RIF 检测发现了 14 例(70%)培养阳性但涂片阴性的病例中的 14 例(13 例涂片阳性-培养阳性和 14 例涂片阴性-培养阳性)。Xpert MTB/RIF 检测比涂片显微镜检查多发现了两倍的病例(79.4%对 41.2%)。年龄>5 岁(比值比 3.3,95%CI 1.4-7.4,p 值 0.005)、结核病(TB)接触史(比值比 2.4,95%CI 1.1-5.2,p 值 0.03)和结核菌素皮肤试验阳性(比值比 4.1,95%CI 1.7-10,p 值 0.02)与 Xpert MTB/RIF 检测阳性相关。LJ 培养的 TB 检出中位时间为 49.5 天(IQR 38.4-61.2),MGIT 培养为 6 天(IQR 5-11.5),Xpert MTB/RIF 检测为 2 小时。

结论

使用一份痰样本的 Xpert MTB/RIF 检测快速且正确地识别了大多数培养确诊为肺结核的儿童,特异性高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/188e/3602671/d5ffb9ec69ac/1471-2334-13-133-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/188e/3602671/d5ffb9ec69ac/1471-2334-13-133-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/188e/3602671/d5ffb9ec69ac/1471-2334-13-133-1.jpg

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