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中国防痨杂志 ›› 2018, Vol. 40 ›› Issue (10): 1066-1070.doi: 10.3969/j.issn.1000-6621.2018.10.007

• 论著 • 上一篇    下一篇

实时荧光核酸恒温扩增检测技术辅助诊断肺外结核的临床价值

聂晓平1,李桓2,杨洪英3,罗明4,杨国强5,周刊4,黄正谷4,王鹏森4,廖传玉4,张汇征4,周刚4,陈玉6,陈耀凯4,石涛7,李同心4,()   

  1. 1. 400036 重庆市公共卫生医疗救治中心检验科
    2. 质量管理科
    3. 康复医学科
    4. 中心实验室
    5. 普通外科与骨科
    6. 病案室
    7. 重庆医科大学附属第三医院骨科
  • 收稿日期:2018-09-08 出版日期:2018-10-10 发布日期:2018-10-18
  • 通信作者: 李同心 E-mail:9608277@qq.com
  • 基金资助:
    重庆市卫生与计划生育委员会2017年医学科研计划面上项目(2017MSXM115)

Clinical value of simultaneous amplification and testing in the auxiliary diagnosis of extrapulmonary tuberculosis

Xiao-ping NIE1,Huan LI2,Hong-ying YANG3,Ming LUO4,Guo-qiang YANG5,Kan ZHOU4,Zheng-gu HUANG4,Peng-sen WANG4,Chuan-yu LIAO4,Hui-zhen ZHANG4,Gang ZHOU4,Yu CHEN6,Yao-kai CHEN4,Tao SHI7,Tong-xin LI4,()   

  1. 1. Department of Clinical Laboratory, Chongqing Public Health Medical Center, Chongqing 400036,China
  • Received:2018-09-08 Online:2018-10-10 Published:2018-10-18
  • Contact: Tong-xin LI E-mail:9608277@qq.com

摘要:

目的 探讨实时荧光核酸恒温扩增检测技术(simultaneous amplification and testing,SAT)辅助诊断肺外结核的价值。 方法 收集2016年1月至2017年12月期间重庆市公共卫生医疗救治中心结核科、普通外科与骨科收治的482例患者肺外样本(主要为病变部位的脓液或手术取出物),根据患者病历记录的临床诊断分为肺外结核(试验组,433例)和排除结核病的其他疾病(对照组,49例)。所有标本同步采用培养法(联合罗氏培养法和BACTEC MGIT 960液体培养法两种方法,只要其中一种培养阳性就视为“培养法”结果为阳性)和SAT检测结核分枝杆菌,并对培养法阳性、SAT检测结果阴性的标本进行菌种鉴定。分别与培养法、患者临床诊断比较,并分析SAT检测的敏感度、特异度和临床辅助诊断肺外结核的价值。 采用SPSS 13.0软件进行分析,计数资料采用χ 2检验,以P<0.05为差异有统计学意义。 结果 试验组127例培养法阳性的标本中TB-SAT检测阳性107例,阴性20例;306例培养法阴性的患者中TB-SAT检测阳性73例,阴性233例。对照组1例标本培养法阳性、TB-SAT检测阴性,其余48例标本培养法与TB-SAT检测均为阴性。以培养法为标准,SAT检测MTB的敏感度、特异度分别是83.6%(107/128)、79.4%(281/354)。与患者临床诊断相比,则培养法的敏感度、特异度分别为29.3%(127/433)、98.0%(48/49);SAT检测MTB的敏感度、特异度分别为41.6%(180/433)、100.0%(49/49)。培养法检测阳性率为29.3%(127/433),SAT法检测阳性率为41.6%(180/433),两者检测阳性率比较,差异有统计学意义(χ 2=14.17,P<0.05)。 结论 SAT检测技术辅助诊断肺外结核具有方便快速、检出率高、敏感度和特异度高等优势,具有较高的临床价值。

关键词: 分枝杆菌, 结核, 核酸扩增技术, 实验室技术和方法, 对比研究, 肺外结核

Abstract:

Objective To explore the clinical value of simultaneous amplification and testing (SAT) in the auxiliary diagnosis of extrapulmonary tuberculosis (TB). Methods We collected abscess fluid or surgical removal tissue samples at the lesion site of inpatients in Department of Tuberculosis, General Surgery and Orthopaedic Surgery of Chongqing Public Health Medical Center between Jan. 2016 and Dec. 2017. Based on the medical records regarding the results of extrapulmonary TB diagnosis, the extrapulmonary TB samples were set as experimental group, and nontuberculous samples as control group. All samples were pretreated by kit manufacturer’s instruction then cultured on solid Lowenstein-Jensen slants and in BACTEC MGIT 960 liquid, and were detected with SAT method. Identification of strains were conducted for specimens with culture-positive and SAT-negative results. The sensitivity, specificity and clinical value of SAT detection for extrapulmonary TB were analyzed, taking the culture method and clinical diagnosis as standards, respectively. The analyses were performed using SPSS 13.0 software. The categorical data were analyzed by χ 2 test, and the difference was statistically significant at P<0.05. Results Among the 127 culture-positive specimens in the experimental group, 107 were positive and 20 were negative by TB-SAT detection. For the 306 culture-negative specimens in the experimental group, 73 were positive and 233 were negative by TB-SAT detection. In the control group, one specimen was positive by culture method and negative by TB-SAT test; the remaining 48 specimens were negative for both culture and TB-SAT method. Compared with the culture method, the sensitivity and specificity of the TB-SAT method were 83.6% (107/128) and 79.4% (281/354), respectively. Meanwhile, compared with the clinical diagnosis of patients, the sensitivity and specificity of the culture method were 29.3% (127/433) and 98.0% (48/49), respectively; and the sensitivity and specificity of the TB-SAT test were 41.6% (180/433) and 100.0% (49/49). The positive rate of culture method was 29.3% (127/433), and the positive rate of SAT method was 41.6% (180/433); the difference was statistically significant (χ 2=14.17, P<0.05). Conclusion Compared with other methods used in this article, TB-SAT has the advantage of higher detection rate, sensitivity, and specificity as well as more convenient and rapid in diagnosis of extrapulmonary TB.

Key words: Mycobacterium tuberculosis, Nucleic acid amplification techniques, Laboratory techniques and procedures, Comparative study, Extrapulmonary tuberculosis