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Xpert MTB/RIF assay 检测在儿童肺结核诊断中的应用:一项系统评价和荟萃分析。

Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in children: a systematic review and meta-analysis.

机构信息

The International Union Against Tuberculosis And Lung Disease (The Union), New York, NY, USA.

Infectious Diseases, Department of Internal Medicine, Baylor College of Medicine, Houston, TX, USA; The Global Tuberculosis Program, Texas Children's Hospital, Houston, TX, USA.

出版信息

Lancet Respir Med. 2015 Jun;3(6):451-61. doi: 10.1016/S2213-2600(15)00095-8. Epub 2015 Mar 24.

DOI:10.1016/S2213-2600(15)00095-8
PMID:25812968
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4756280/
Abstract

BACKGROUND

Microbiological confirmation of childhood tuberculosis is rare because of the difficulty of collection of specimens, low sensitivity of smear microscopy, and poor access to culture. We aimed to establish summary estimates for sensitivity and specificity of of the Xpert MTB/RIF assay compared with microscopy in the diagnosis of pulmonary tuberculosis in children.

METHODS

We searched for studies published up to Jan 6, 2015, that used Xpert in any setting in children with and without HIV infection. We systematically reviewed studies that compared the diagnostic accuracy of Xpert MTB/RIF (Xpert) with microscopy for detection of pulmonary tuberculosis and rifampicin resistance in children younger than 16 years against two reference standards-culture results and culture-negative children who were started on anti-tuberculosis therapy. We did meta-analyses using a bivariate random-effects model.

FINDINGS

We identified 15 studies including 4768 respiratory specimens in 3640 children investigated for pulmonary tuberculosis. Culture tests were positive for tuberculosis in 12% (420 of 3640) of all children assessed and Xpert was positive in 11% (406 of 3640). Compared with culture, the pooled sensitivities and specificities of Xpert for tuberculosis detection were 62% (95% credible interval 51-73) and 98% (97-99), respectively, with use of expectorated or induced sputum samples and 66% (51-81) and 98% (96-99), respectively, with use of samples from gastric lavage. Xpert sensitivity was 36-44% higher than was sensitivity for microscopy. Xpert sensitivity in culture-negative children started on antituberculosis therapy was 2% (1-3) for expectorated or induced sputum. Xpert's pooled sensitivity and specificity to detect rifampicin resistance was 86% (95% credible interval 53-98) and 98% (94-100), respectively.

INTERPRETATION

Compared with microscopy, Xpert offers better sensitivity for the diagnosis of pulmonary tuberculosis in children and its scale-up will improve access to tuberculosis diagnostics for children. Although Xpert helps to provide rapid confirmation of disease, its sensitivity remains suboptimum compared with culture tests. A negative Xpert result does not rule out tuberculosis. Good clinical acumen is still needed to decide when to start antituberculosis therapy and continued research for better diagnostics is crucial.

FUNDING

WHO, Global TB Program of Texas Children's Hospital.

摘要

背景

由于标本采集困难、涂片显微镜检查敏感性低以及培养条件有限,儿童结核病的微生物学确诊很少见。本研究旨在评估 Xpert MTB/RIF 检测与显微镜检查相比在儿童肺结核诊断中的敏感性和特异性汇总估计值。

方法

我们检索了截至 2015 年 1 月 6 日发表的在有或无 HIV 感染的儿童中使用 Xpert 的任何研究。我们系统地综述了比较 Xpert MTB/RIF(Xpert)检测与显微镜检查在儿童肺结核和利福平耐药诊断中的准确性的研究,这些研究的参考标准是培养结果和接受抗结核治疗的培养阴性儿童。我们使用双变量随机效应模型进行了荟萃分析。

结果

我们共确定了 15 项研究,其中包括 3640 例疑似肺结核患儿的 4768 份呼吸道标本。所有患儿中,培养检测结核病阳性率为 12%(420/3640),Xpert 阳性率为 11%(406/3640)。与培养相比,Xpert 检测肺结核的敏感性和特异性的汇总值分别为 62%(95%可信区间 51-73)和 98%(97-99),使用的标本为咳出或诱导痰液,分别为 66%(51-81)和 98%(96-99),使用的标本为胃液抽吸物。Xpert 的敏感性比显微镜检查高 36-44%。培养阴性且开始抗结核治疗的患儿,使用咳出或诱导痰液时,Xpert 的阳性率为 2%(1-3)。Xpert 检测利福平耐药的敏感性和特异性的汇总值分别为 86%(95%可信区间 53-98)和 98%(94-100)。

结论

与显微镜检查相比,Xpert 可提高儿童肺结核诊断的敏感性,其推广将改善儿童结核病诊断的可及性。尽管 Xpert 有助于快速确认疾病,但与培养试验相比,其敏感性仍不理想。Xpert 检测结果阴性不能排除结核病。仍需要良好的临床判断来决定何时开始抗结核治疗,继续研究更好的诊断方法至关重要。

资金来源

世界卫生组织、德克萨斯儿童医院全球结核病项目。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbbb/4756280/24562746534e/nihms755767f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbbb/4756280/ad896e97e345/nihms755767f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbbb/4756280/74d8de22bf64/nihms755767f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbbb/4756280/87cf07d33375/nihms755767f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbbb/4756280/24562746534e/nihms755767f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbbb/4756280/ad896e97e345/nihms755767f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbbb/4756280/74d8de22bf64/nihms755767f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbbb/4756280/87cf07d33375/nihms755767f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbbb/4756280/24562746534e/nihms755767f4.jpg

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