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Xpert® MTB/RIF Ultra 试验检测后口咽唾液对少菌性肺结核的诊断准确性:一项前瞻性多中心研究。

Accuracy of Xpert® MTB/RIF Ultra test for posterior oropharyngeal saliva for the diagnosis of paucibacillary pulmonary tuberculosis: a prospective multicenter study.

机构信息

Department of Tuberculosis, The Fifth People's Hospital of Suzhou, The Affiliated Infectious Diseases Hospital, Suzhou Medical College of Soochow University, Suzhou, People's Republic of China.

Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.

出版信息

Emerg Microbes Infect. 2023 Dec;12(1):2148564. doi: 10.1080/22221751.2022.2148564.

DOI:10.1080/22221751.2022.2148564
PMID:36377487
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9754037/
Abstract

BACKGROUND

Posterior oropharyngeal saliva (POS) is increasingly recognized as an alternative specimen for detecting respiratory pathogens. The accuracy of Xpert® MTB/RIF Ultra (X-Ultra), when performed on POS obtained from patients with paucibacillary pulmonary tuberculosis (TB) is unclear.

METHODS

We consecutively recruited adults with symptoms suggestive of pulmonary TB who were negative by both smear microscopy and Xpert MTB/RIF (X-Classic). Each participant was required to provide one bronchoalveolar lavage fluid (BALF) and one POS specimen, respectively. Diagnostic performances of X-Ultra and X-Classic on POS were compared against clinical and mycobacterial reference standards.

FINDINGS

686 participants meeting inclusion criteria were consecutively enrolled into the study. The overall diagnostic sensitivities of X-Ultra and X-Classic on POS samples were 78.9% [95% confidence interval (CI): 72.8-83.8] and 56.4% (95% CI: 49.7-62.9), respectively; the specificities were 96.6% (95% CI: 94.3-98.1) for X-Ultra and 97.6 (95CI: 95.5-98.8) for X-Classic in POS specimens. Notably, the sensitivity of X-Ultra on POS was as sensitive as X-Classic on BALF against microbiological reference standard (78.9% VS 73.1%). Against clinical diagnosis as a reference standard, the sensitivities of X-Ultra and X-Classic on POS were 55.9% (95% CI: 50.5-61.2; 193/345) and 40.0% (95% CI: 34.8-45.4; 138/345), respectively. The risk of negative results with POS was dramatically increased with decreasing bacterial loads.

CONCLUSIONS

The testing of POS using X-Ultra shows promise as a tool to identify patients with paucibacillary TB. Considering that bronchoscopy is a semi-invasive procedure, POS testing ahead of bronchoscopy, may decrease the need for bronchoscopic procedures, and the cost of care.

摘要

背景

越来越多的人认为后口咽唾液(POS)是一种替代标本,可用于检测呼吸道病原体。然而,对于菌量较少的肺结核(TB)患者,Xpert® MTB/RIF Ultra(X-Ultra)在 POS 标本上的准确性尚不清楚。

方法

我们连续招募了症状提示肺结核且痰涂片镜检和 Xpert MTB/RIF(X-Classic)均为阴性的成人患者。每位患者分别提供支气管肺泡灌洗液(BALF)和 POS 标本。比较 X-Ultra 和 X-Classic 在 POS 标本上的诊断性能与临床和分枝杆菌参考标准。

结果

符合纳入标准的 686 名参与者连续入组本研究。X-Ultra 和 X-Classic 在 POS 样本中的总体诊断敏感性分别为 78.9%[95%置信区间(CI):72.8-83.8]和 56.4%(95%CI:49.7-62.9),特异性分别为 96.6%(95%CI:94.3-98.1)和 97.6(95%CI:95.5-98.8)。值得注意的是,X-Ultra 在 POS 标本中的敏感性与 X-Classic 在 BALF 标本中的敏感性相当,符合微生物学参考标准(78.9%VS73.1%)。以临床诊断为参考标准,X-Ultra 和 X-Classic 在 POS 标本中的敏感性分别为 55.9%(95%CI:50.5-61.2;193/345)和 40.0%(95%CI:34.8-45.4;138/345)。随着细菌载量的降低,POS 检测结果为阴性的风险显著增加。

结论

使用 X-Ultra 检测 POS 显示出作为一种识别菌量较少的 TB 患者的工具的潜力。考虑到支气管镜检查是一种半侵袭性操作,在支气管镜检查之前进行 POS 检测可能会减少对支气管镜检查程序的需求,以及医疗成本。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7918/9754037/e46faa40f516/TEMI_A_2148564_F0003_OB.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7918/9754037/a9dce6acff0e/TEMI_A_2148564_F0001_OB.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7918/9754037/589c0b0ac710/TEMI_A_2148564_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7918/9754037/e46faa40f516/TEMI_A_2148564_F0003_OB.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7918/9754037/a9dce6acff0e/TEMI_A_2148564_F0001_OB.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7918/9754037/589c0b0ac710/TEMI_A_2148564_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7918/9754037/e46faa40f516/TEMI_A_2148564_F0003_OB.jpg

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