摘要
目的评估超敏结核分枝杆菌和利福平耐药基因检测(XpertUltra)方案检测痰液及支气管肺泡灌洗液(BALF)标本在涂阴肺结核患者中早期、快速诊断的价值。方法选择2020年5月-2021年12月在山东省公共卫生临床中心就诊的痰涂片阴性疑似肺结核患者93例,其中临床诊断为涂阴肺结核57例,非肺结核36例。收集所有患者的痰液及BALF标本,分别采用Xpert Ultra、GeneXpert MTB/RIF(Xpert)、BACTEC MGIT 960培养(MGIT 960培养)进行检测。以临床诊断为参考标准,评价3种检测方案及相互联合检测痰液及BALF标本时诊断涂阴肺结核的敏感度、特异度及符合率。结果以临床诊断结果为参考标准,Xpert Ultra检测痰液标本对涂阴肺结核诊断的敏感度明显高于Xpert[56.14%(32/57)vs.36.84%(21/57),P=0.03]和MGIT960培养[56.14%(32/57)vs.33.33%(19/57),P=0.014];Xpert Ultra检测BALF标本对涂阴肺结核诊断的敏感度明显高于Xpert[75.44%(43/57)vs.56.14%(32/57),P=0.030]和MGIT960培养[75.44%(43/57)vs.38.60%(22/57),P<0.01]。3种检测方案及相互联合检测痰液标本诊断涂阴肺结核,受试者工作特征(ROC)曲线下面积(AUC)依次为:三者联合(0.807)>Xpert Ultra+Xpert(0.798)>Xpert Ultra+MGIT 960培养(0.789)>Xpert Ultra(0.781)>Xpert(0.684)>MGIT 960培养(0.667);检测BALF标本,AUC依次为:三者联合(0.895)=Xpert Ultra+Xpert(0.895)>XpertUltra+MGIT960培养(0.877)=XpertUltra(0.877)>Xpert(0.781)>MGIT960培养(0.693)。3种检测方案均未在入组患者中检测到利福平耐药。结论Xpert Ultra对早期、快速诊断涂阴肺结核具有较高的临床应用价值;其检测BALF的敏感度高于痰液标本,建议优先选择BALF标本。
Objective To evaluate the value of GeneXpert MTB/RIF Ultra(Xpert Ultra)in the early and rapid diagnosis of sputum and bronchoalveolar lavage fluid(BALF)samples in patients with smeared negative tuberculosis.Methods A total of 93 patients with sputum smear-negative suspected pulmonary tuberculosis who were admitted to Shandong Public Health Clinical Center from May 2020 to December 2021 were included in this study.Among them,57 patients were clinically diagnosed as sputum smear-negative pulmonary tuberculosis and 36 patients were non-pulmonary tuberculosis.Sputum and BALF samples were collected from all patients,and Xpert Ultra,GeneXpert MTB/RIF(Xpert),BACTEC MGIT 960 culture(MGIT 960 culture)were performed.To evaluate the sensitivity,specificity and coincidence rate of various detection methods and their combined detection of sputum and bronchoalveolar lavage fluid samples in the diagnosis of smeared negative pulmonary tuberculosis.Results Taking clinical diagnosis as the reference standard,the sensitivity of sputum samples detected by Xpert Ultra for the diagnosis of smeared negative pulmonary tuberculosis was significantly higher than that of Xpert[56.14%(32/57)vs.36.84%(21/57),P=0.039]and MGIT 960 culture[56.14%(32/57)vs.33.33%(19/57),P=0.014].The sensitivity of BALF samples detected by Xpert Ultra for the diagnosis of smeared negative pulmonary tuberculosis was significantly higher than that of Xpert[75.44%(43/57)vs.56.14%(32/57),P=0.030]and MGIT 960 culture[75.44%(43/57)vs.38.60%(22/57),P<0.01].Three different methods of testing sputum samples,the area under the receiver operating characteristic curve(AUC)was the combination of the three elements(0.807)>Xpert Ultra+Xpert(0.798)>Xpert Ultra+MGIT 960 culture(0.789)>Xpert Ultra method(0.781)>Xpert(0.684)>MGIT 960 culture(0.667);Samples of BALF were examined,the AUC was the combination of the three elements(0.895)=Xpert Ultra+Xpert(0.895)>Xpert Ultra+MGIT 960 culture(0.877)=Xpert Ultra method(0.877)>Xpert(0.781)>culture method(0.693).Rifampicin resistance was not detected in the enrolled samples by the three detection methods.Conclusions Xpert Ultra has high clinical application value in the early and rapid diagnosis of smeared negative pulmonary tuberculosis,and the sensitivity of Xpert Ultra in the detection of BALF is higher than that of sputum sample,so the BALF sample is recommended as prior selection.
作者
丁彩红
王余余
王庆
高绪胜
解丹
熊瑜
Ding Cai-Hong;Wang Yu-Yu;Wang Qing;Gao Xu-Sheng;Xie Dan;Xiong Yu(Tuberculosis Medicine,Public Health Clinical Center Affiliated to Shandong University,Jinan,Shandong 250102,China)
出处
《解放军医学杂志》
CAS
CSCD
北大核心
2023年第7期761-767,共7页
Medical Journal of Chinese People's Liberation Army
基金
山东省重点研发计划(重大科技创新工程)项目(2021SFGC0504)
山东省医药卫生科技发展计划项目(2019WS523)
山东省中医药科技项目(2020M059)。
