摘要
目的 评价Gene Xpert MTB/RIF（简称“Xpert”）在HIV阴性泌尿系结核中的诊断价值.方法 连续纳入2016年2月至2017年2月在沈阳市胸科医院、上海市公共卫生临床中心、武汉市肺科医院、深圳市第三人民医院等4家结核病专科医院就诊的119例HIV阴性疑似泌尿系结核的患者.收集所有患者的24 h尿沉渣标本,每份标本同时进行涂片查抗酸杆菌、BACTEC MGIT 960（简称“MGIT 960”）分枝杆菌培养、Xpert检测.以临床确定诊断作为金标准,评价Xpert检测尿液标本的敏感度和特异度,对所有培养阳性菌株进行利福平药物敏感性检测,并对Xpert检测结果与MGIT 960药敏检测结果一致性进行比较.结果 119例患者中有59例（49.6％）患者临床确诊为泌尿系结核,60例（50.4％）患者临床诊断为非泌尿系结核.59例泌尿系结核患者中,25例（42.4％）MGIT 960分枝杆菌培养阳性;34例（57.6％）按临床表现、泌尿系影像、抗结核治疗效果等临床标准诊断为泌尿系结核患者.以临床确诊为金标准,Xpert检测的敏感度为64.4％（38/59）,特异度为100.0％（60/60）,抗酸杆菌涂片法敏感度为11.9％（7/59）,两者敏感度比较差异有统计学意义（x2 =25.97,P＜0.001）;MGIT 960分枝杆菌培养法敏感度为42.4％（25/59）,与xpert检测比较差异有统计学意义（x2=11.27,P=0.001）.在MGIT 960分枝杆菌培养阳性的患者中,Xpert检测的敏感度为96.0％（24/25）.涂片和培养均阴性而临床诊断为泌尿系结核的患者Xpert检测的阳性率为43.8％（14/32）.结论 Xpert检测尿液标本中结核分枝杆菌的敏感度和特异度高,并且可以同时检测利福平耐药.Xpert优于抗酸杆菌涂片及BACTEC MGIT 960分枝杆菌液体培养等传统泌尿系结核诊断方法,可用于早期诊断HIV阴性的泌尿系结核.
Objective To evaluate the diagnostic performance of GeneXpert MTB/RIF for urinary tuberculosis （UTB） of HIV negative population.Methods In this prospective pilot study,one hundred and nineteen HIV negative patients with suspected UTB were consecutively enrolled between February 2016 and February 2017 from four TB-specialized Hospitals in China,namely the Department of Tuberculosis of Shenyang Chest Hospital,Shanghai Public Health Clinical Center,Wuhan Pulmonary Hospital,Shenzhen Third People＆#39;s Hospital.Samples were collected from all patients＆#39; 24-hour urinary sediment.For every sample,smear microscopy was performed to test acid-fast bacilli （AFB）,BACTEC MGIT 960 （shortened as ＆quot;MGIT 960＆quot; hereafter） was used for culture and Xpert testing.With clinical diagnosis as the gold standard,the sensitivity and specificity of Xpert in its testing performance on urine samples was evaluated.All positive strains tested for susceptibility against rifampin （RIF）,and the results were compared between MGIT 960 susceptibility testing results and Xpert testing results.Results Among these 119 suspected patients,59 patients （49.6%） were confirmed as UTB,60 patients （50.4%） were diagnosed without UTB.Among the 59 cases of UTB,25 （42.4%） were MGIT 960 culture-positive,and 34 （57.6%） were diagnosed as UTB based on standard clinical diagnosis,including the clinical signs,imaging of urinary system,and anti-TB treatment results.With clinical diagnosis as the gold standard,the sensitivity of Xpert assay was 64.4% （38/59）,and the specificity was 100.0% （60/60）;the sensitivity of AFB smear was 11.9% （7/59）,and the difference was statistically significant （x2=25.97,P〈0.001）;the sensitivity of MGIT 960 culture was 42.4% （25/59）,which was statistically different from Xpert （x2=11.27,P=0.001）.Among the patients who were culture-positive,the sensitivity of Xpert was 96.0% （24/25）.Among those negative for both smear and culture,but diagnosed UTB based on clinical diagnosis,the positivity rate of Xpert diagnosis was 43.8% （14/32）.Concision Xpert demonstrated high sensitivity and specificity in detecting Mycobacterium tuberculosis,and it could be used to detect RIF resistance simultaneously.Xpert has achieved better performance than traditional diagnosis methods such as AFB smear and MGIT 960 DST of M.tuberculosis and could be used in early diagnosis UTB among the HIV negative patients.
作者
陈禹
刘旭晖
付亮
陈国玺
李桂琴
刘宇红
张峣
LIU Xu-hui FU Liang CHEN Guo-xi LI Gui-qin LIU Yu hong ZHANG Yao(Shenyang Chest Hospital and Shenyang Tenth People＇s Hospital, Shenyang 110044, China)
出处
《中国防痨杂志》
CAS
2017年第10期1100-1106,共7页
Chinese Journal of Antituberculosis
基金
中国结核病临床试验合作中心科研项目（2017KYJJ003）
关键词
结核
泌尿生殖系统
核酸扩增技术
实验室技术和方法
对比研究
早期诊断
Tuberculosis,urogenital
Nucleic acid amplification techniques
Laboratory techniques and procedures
Comparative study
Early diagnosis
