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中国防痨杂志 ›› 2022, Vol. 44 ›› Issue (2): 141-146.doi: 10.19982/j.issn.1000-6621.20210668

• 论著 • 上一篇    下一篇

GeneXpert MTB/RIF Ultra检测手术组织对结核病的诊断价值

雷静1, 邬霞1, 谈小文1, 李爱芳1, 崔晓利1, 康磊1, 庞健健2, 任斐3, 吴守振4, 杨翰5()   

  1. 1西安市胸科医院检验科,西安 710100
    2西安市胸科医院肺结核二科,西安 710100
    3西安市胸科医院耐药结核科,西安 710100
    4西安市儿童医院检验科,西安 710003
    5西安市胸科医院转化医学中心,西安 710100
  • 收稿日期:2021-11-22 出版日期:2022-02-10 发布日期:2022-02-14
  • 通信作者: 杨翰 E-mail:xajhyanghan@163.com
  • 基金资助:
    西安市卫生健康委员会科研项目(2020yb38);西安市创新能力强基计划(21YXYJ0003)

Diagnostic value of GeneXpert MTB/RIF Ultra in testing surgical tissue specimens for diagnosing tuberculosis

LEI Jing1, WU Xia1, TAN Xiao-wen1, LI Ai-fang1, CUI Xiao-li1, KANG Lei1, PANG Jian-jian2, REN Fei3, WU Shou-zhen4, YANG Han5()   

  1. 1Department of Laboratory Medicine, Xi’an Chest Hospital,Xi’an 710100, China
    2Second Department of Tuberculosis, Xi’an Chest Hospital,Xi’an 710100, China
    3Department of Drug-resistant Tuberculosis, Xi’an Chest Hospital,Xi’an 710100, China
    4Department of Laboratory Medicine, Xi’an Children’s Hospital, Xi’an 710003, China
    5Translational Medicine Center of Xi’an Chest Hospital,Xi’an 710100, China
  • Received:2021-11-22 Online:2022-02-10 Published:2022-02-14
  • Contact: YANG Han E-mail:xajhyanghan@163.com
  • Supported by:
    Scientific Research Project of Xi’an Municipal Health Commission(2020yb38);Xi’an City Innovation Capability Strong Foundation Plan(21YXYJ0003)

摘要:

目的: 评估GeneXpert MTB/RIF Ultra(简称“Xpert Ultra”)检测手术组织和脓液标本对结核病的诊断价值。方法: 采用前瞻性研究的方法,收集2021年1—9月西安市胸科医院疑似结核病患者符合检测样本量的同一病灶的手术组织样本49份和脓液样本36份,分别对其进行Xpert Ultra、GeneXpert MTB/RIF(简称“Xpert”)、BACTEC MGIT 960液体培养(简称“MGIT 960培养”)、DNA实时荧光定量核酸扩增检测(FQ-PCR)、结核分枝杆菌RNA实时荧光恒温扩增(SAT-RNA)、DNA实时荧光恒温扩增法(简称“恒温扩增法”)检测。以临床诊断结果为参考标准,评价上述各种方法检测手术组织标本对结核病的诊断价值;同时,分析各方法检测确诊结核病患者同一病灶组织及脓液标本(各28份)阳性率的差异。结果: 以结核病临床诊断为参考标准,Xpert Ultra检测组织标本的敏感度(75.0%,24/32)明显高于Xpert(65.6%,21/32)、FQ-PCR(53.1%,17/32)、SAT-RNA(25.0%,8/24)、恒温扩增法(6.3%,2/30)及MGIT 960培养(37.5%,12/32),差异均有统计学意义(χ2=32.919,P<0.001;χ2=21.866,P<0.001;χ2=5.418,P=0.020;χ2=15.228,P<0.001;χ2=11.574,P=0.001)。一致性分析显示:Xpert Ultra与临床诊断结果高度一致(Kappa值为0.675),Xpert和FQ-PCR为中等一致(Kappa值分别为0.570和0.444),MGIT 960培养为一般一致(Kappa值为0.294),SAT-RNA和恒温扩增法为极低一致(Kappa值分别为0.188和0.044)。受试者工作特征曲线下面积依次为Xpert Ultra法(0.875)、Xpert(0.828)、FQ-PCR(0.766)、培养法(0.688)、SAT-RNA(0.625)和恒温扩增法(0.531)。Xpert Ultra检测结核病患者同一病灶脓液与组织标本的阳性率分别为78.6%(22/28)和71.4%(20/28),差异无统计学意义(χ2=0.382,P=0.537)。结论: Xpert Ultra检测手术组织及脓液标本对结核病具有较高的快速诊断价值,且无需同时检测患者同一病灶不同标本类型,但考虑采样的可及性和合格率,应优先选择组织标本。

关键词: 分子诊断技术, 活组织检查, 实验室技术和方法, 评价研究

Abstract:

Objective: To evaluate the diagnostic value of GeneXpert MTB/RIF Ultra (Xpert Ultra) in testing surgical tissue and pus specimens for tuberculosis. Methods: This prospective research collected surgical tissue and pus specimens from clinically presumptive tuberculosis patients in Xi’an Chest Hospital from January to September 2021. These samples includes 49 surgical tissues and 36 pus from the same lesion of the patients. Xpert Ultra, GeneXpert MTB/RIF (Xpert), BACTEC MGIT 960 liquid culture (MGIT 960 culture), DNA real-time fluorescent quantitative nucleic acid amplification detection (FQ-PCR), RNA real-time fluorescence constant temperature amplification (SAT-RNA), DNA real-time fluorescence constant temperature amplification method (CTM-DNA) were performed on these specimens. The clinical diagnosis result was used as the reference standard to evaluate the diagnostic value of surgical tissues of the above-mentioned various methods; differences of positive rates of the tissues and pus specimens from the same yielded of tuberculosis patients (each 28) by each method were analyzed. Results: The sensitivity of Xpert Ultra (75.0%, 24/32) on tissue samples was significantly higher than that of Xpert (65.6%, 21/32), FQ-PCR (53.1%, 17/32), SAT-RNA (25.0%, 8/24), CTM-DNA (6.3%, 2/30) and MGIT 960 culture (37.5%, 12/32). The differences between Xpert Ultra and other methods were statistically significant (χ2=32.919, P<0.001; χ 2=21.866, P<0.001; χ 2=5.418, P=0.020; χ 2=15.228, P<0.001; χ 2=11.574, P=0.001). Consistency analysis results showed: Xpert Ultra was highly consistent with clinical diagnosis results (Kappa: 0.675), Xpert and FQ-PCR were moderately consistent with clinical results (Kappa: 0.570, 0.444), MGIT 960 culture was mildly consistent (Kappa: 0.294), SAT-RNA and CTM-DNA were very poorly consistent (Kappa: 0.188, 0.044).The areas under the receiver operating characteristic curve were 0.875 for Xpert Ultra, 0.828 for Xpert MTB/RIF, 0.766 for FQ-PCR, 0.688 for culture method, 0.625 for SAT-RNA and 0.531 for CTM-DNA. The positive rates of Xpert Ultra in detecting pus and tissue samples from the same lesion of patients were 78.6% (22/28) and 71.4% (20/28),and the difference was not statistically significant (χ 2=0.382, P=0.537). Conclusion: Xpert Ultra on surgical tissue and pus specimens had a high rapid diagnostic value for tuberculosis, and there was no need to detect different types of specimen from the same lesion of patients at the same time, but considering the availability and quality of sampling, tissue specimens should be preferred.

Key words: Molecular diagnostic techniques, Biopsy, Laboratory techniques and procedures, Evaluation studies

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