摘要
目的:评估GeneXpert MTB/RIF Ultra(简称“Xpert Ultra”)检测痰液样本对新发肺结核的诊断价值。方法:连续收集2019年7月至2022年5月山东省公共卫生临床中心就诊的疑似新发肺结核患者作为研究对象,共纳入443例,最终经临床综合诊断,肺结核组243例,非肺结核组200例。收集研究对象的痰液样本,分别进行荧光染色涂片镜检、BACTEC MGIT 960液体培养(简称“MGIT 960培养”)、Xpert Ultra及GeneXpert MTB/RIF(简称“Xpert”)检测,培养阳性样本进行菌种鉴定;对231例患者的痰液样本(肺结核组125例、非肺结核组106例)同时进行Xpert Ultra直接检测与离心沉淀处理后的检测。分别以临床综合诊断结果及MGIT 960培养结果作为参考标准,评价上述各方法对于新发肺结核的诊断价值。结果:以临床综合诊断为参考标准,Xpert Ultra的敏感度和特异度分别为68.72%(167/243)和100.00%(200/200),敏感度高于涂片荧光染色镜检的36.63%(89/243)和MGIT 960培养的62.14%(151/243),差异均有统计学意义(χ2=54.830,P<0.001;χ2=3.198,P<0.05);受试者工作特征曲线下面积(AUC)最大,为0.809,且与临床综合诊断高度一致(Kappa值为0.66)。以MGIT 960培养为参考标准,Xpert Ultra的敏感度和特异度分别为94.70%(143/151)和94.52%(276/292),敏感度高于涂片荧光染色镜检的60.26%(91/151)和Xpert的90.07%(136/151),差异均有统计学意义(χ2=13.411,P<0.001;χ2=3.847 P<0.05),AUC为0.946,诊断效能最高,且与MGIT 960培养的几乎完全一致(Kappa值为0.88)。Xpert Ultra能够准确区分结核分枝杆菌和非结核分枝杆菌,其“痕量”结果可以作为新发肺结核的诊断依据。对231例患者痰液样本进行直接检测和离心沉淀处理后检测,以临床综合诊断结果作为参照标准,对比分析发现,Xpert Ultra检测经过沉淀处理的痰液标本的敏感度(80.00%,100/125)比直接检测的痰液标本的敏感度(68.00%,85/125)提高了12.00%;肺结核组31.20%(39/125)的样本半定量结果提升了至少一个数量级。结论:Xpert Ultra检测痰液样本对新发肺结核具有较好的诊断效能,对新发肺结核的快速诊断和治疗具有重要价值。
Objective:To evaluate the diagnostic performance of GeneXpert MTB/RIF Ultra(referred to as“Xpert Ultra”)in detecting sputum samples for newly diagnosed pulmonary tuberculosis.Methods:A total of 443 suspected new cases of pulmonary tuberculosis patients who visited the Shandong Public Health Clinical Center from July 2019 to May 2022 were collected as research subjects.After comprehensive clinical diagnosis,there were 243 cases in the pulmonary tuberculosis group and 200 cases in the non-pulmonary tuberculosis group.After collecting sputum samples from the research subjects,they were subjected to fluorescence staining smear microscopy,BACTEC MGIT 960 liquid culture(referred to as“MGIT 960 culture”),Xpert Ultra,and GeneXpert MTB/RIF(referred to as“Xpert”)detection;MGIT 960 cultured positive samples were further subjected to strain identification.Sputum samples from 231 patients(125 in the tuberculosis group and 106 in the non-pulmonary tuberculosis group)were simultaneously subjected to Xpert Ultra direct detection and centrifugal precipitation treatment.Using the clinical comprehensive diagnosis results and MGIT 960 culture results as reference standards,evaluate the diagnostic value of the above methods for newly diagnosed pulmonary tuberculosis.Results:Using clinical comprehensive diagnosis as the reference standard,the sensitivity and specificity of Xpert Ultra were 68.72%(167/243)and 100.00%(200/200),respectively.The sensitivity of Xpert Ultra was higher than smear fluorescence staining microscopy(36.63%(89/243))and MGIT 960 culture(62.14%(151/243)),and the differences were statistically significant(χ2=54.830,P<0.001;χ2=3.198,P<0.05).The AUC of Xpert Ultra was the largest,which was 0.809,and highly consistent with clinical comprehensive diagnosis(Kappa value of 0.66).Using MGIT 960 culture as the reference standard,the sensitivity and specificity of Xpert Ultra were 94.70%(143/151)and 94.52%(276/292),respectively.The sensitivity of Xpert Ultra was higher than smear fluorescence staining microscopy(60.26%(91/151))and Xpert(90.07%(136/151)),and the differences were statistically significant(χ2=13.411,P<0.001;χ2=3.847,P<0.05);and the AUC of Xpert Ultra was 0.946,indicating the highest diagnostic efficiency and almost identical to that of MGIT 960 culture(Kappa value of 0.88).Xpert Ultra can accurately distinguish between Mycobacterium tuberculosis and nontuberculous mycobacteria,and its“trace”results could serve as a diagnostic basis for newly diagnosed pulmonary tuberculosis.For the 231 patients’sputum samples,direct testing and testing after centrifugal sedimentation were performed,and using clinical comprehensive diagnosis as the reference standard,it was found that the sensitivity of Xpert Ultra testing on sedimented sputum samples(80.00%,100/125)was 12.00%higher than that of direct testing on sputum samples(68.00%,85/125);in the tuberculosis group,31.20%(39/125)of the samples showed at least a one-log increase in semi-quantitative results.Conclusion:Xpert Ultra testing of sputum samples has good diagnostic performance for newly diagnosed pulmonary tuberculosis and is of significant value for its rapid diagnosis and treatment.
作者
贾辉
景辉
凌晓洁
王燕
李学政
Jia Hui;Jing Hui;Ling Xiaojie;Wang Yan;Li Xuezheng(Katharine Hsu International Research Center of Human Infectious Diseases,Shandong Public Health Clinical Center Affiliated to Shandong University,Ji’nan 250001,China)
出处
《中国防痨杂志》
北大核心
2025年第3期298-304,共7页
Chinese Journal of Antituberculosis
基金
山东省中医药科技项目(2021M215)
济南市卫健委科技计划项目(2021-公-25)。
关键词
结核
肺
痰
诊断
鉴别
分子诊断技术
Tuberculosis,pulmonary
Sputum
Diagnosis,differential
Molecular diagnostic techniques
