Wang S H, Zheng D W, Zhu Y K, Ma X G, Shi J, Ou X C, Li H, Xing J, Zhao Y L
Tuberculosis Reference Laboratory, Henan Center of Disease Control and Prevention, Zhengzhou 450016, China.
Zhonghua Jie He He Hu Xi Za Zhi. 2018 Feb 12;41(2):105-110. doi: 10.3760/cma.j.issn.1001-0939.2018.02.007.
To compare the efficacies of cross priming amplification (CPA) and RealAmp with XpertMTB/RIF for the diagnosis of pulmonary tuberculosis(TB) at peripheral microscopic centers. From December of 2014 to December of 2015, 3 193 patients suspected with TB were enrolled consecutively at 3 county level TB clinical clinics in Zhongmu, Xinmi and Dengzhou of Henan province. Totally 3 193 collected sputum samples were detected by smear microscopy, L-J media culture, CPA, RealAmp and Xpert MTB/RIF. The culture positive samples were tested by MPB64 for strain identification. The sensitivity and specificity of CPA, RealAmp and Xpert MTB/RIF were calculated according to L-J solid culture results and clinical diagnosis results. The sensitivity of CPA, RealAmp and Xpert MTB/RIF were 85.5%(413/483), 85.5%(413/483) and 87.9%(422/480), respectively, compared with L-J solid culture, the difference among the 3 methods being not significant(χ(2)=1.6, >0.05). The specificity of CPA, RealAmp and Xpert MTB/RIF were 96.8%(2 624/2 170), 93.2%(2 527/2 170) and 95.3%(2 567/2 170) compared with culture; and there was a significantly statistic difference among the 3 methods(χ(2)=37.8, <0.001). The sensitivity of smear microscopy, culture, CPA, RealAmp and Xpert MTB/RIF was 21.7%(300/1 383), 34.9%(483/1 383), 34.6%(478/1 383), 39.2%(542/1 383) and 38.1%(526/1 381) compared with clinical diagnosis. The sensitivity of CPA, RealAmp and Xpert MTB/RIF was higher than that of smear (χ(2) =31.9, <0.01), but there was no significantly statistic difference between the 3 molecular methods(χ(2)=2.9, >0.05). The specificity of smear microscopy, L-J solid culture, CPA, RealAmp and Xpert MTB/RIF was 100%(1 810/1 810), 100%(1 810/1 810), 98.8%(1 789/1 810), 98.8%(1 756/1 810) and 97.0%(1 788/1 810), and there was no significantly statistic difference among the 3 molecular methods(χ(2)=0.16, >0.05). The capability of CPA and RealAmp for diagnosing pulmonary TB was similar to Xpert MTB/RIF.The former 2 methods were more suitable to apply to the diagnoses of pulmonary TB in peripheral laboratories.
比较交叉引物扩增法（CPA）、RealAmp以及Xpert MTB/RIF在基层显微中心诊断肺结核（TB）的效能。2014年12月至2015年12月，在河南省中牟、新密和邓州的3个县级结核病临床诊疗机构连续纳入3193例疑似结核病患者。对收集的3193份痰标本进行涂片显微镜检查、罗氏培养基培养、CPA、RealAmp以及Xpert MTB/RIF检测。对培养阳性标本进行MPB64检测以鉴定菌株。根据罗氏固体培养结果和临床诊断结果计算CPA、RealAmp以及Xpert MTB/RIF的敏感度和特异度。与罗氏固体培养相比，CPA、RealAmp以及Xpert MTB/RIF的敏感度分别为85.5%（413/483）、85.5%（413/483）和87.9%（422/480），3种方法间差异无统计学意义（χ²=1.6，P>0.05）。与培养相比，CPA、RealAmp以及Xpert MTB/RIF的特异度分别为96.8%（2624/2710）、93.2%（2527/2710）和95.3%（2567/2710），3种方法间差异有统计学意义（χ²=37.8，P<0.001）。与临床诊断相比，涂片显微镜检查、培养、CPA、RealAmp以及Xpert MTB/RIF的敏感度分别为21.7%（300/1383）、34.9%（483/1383）、34.6%（478/1383）、39.2%（542/1383）和38.1%（526/1381）。CPA、RealAmp以及Xpert MTB/RIF的敏感度高于涂片（χ²=31.9，P<0.01），但3种分子方法间差异无统计学意义（χ²=2.9，P>0.05）。涂片显微镜检查、罗氏固体培养、CPA、RealAmp以及Xpert MTB/RIF的特异度分别为100%（1810/1810）、100%（1810/1810）、98.8%（1789/1810）、98.8%（1756/1810）和97.0%（1788/1810），3种分子方法间差异无统计学意义（χ²=0.16，P>0.05）。CPA和RealAmp诊断肺结核的能力与Xpert MTB/RIF相似。前两种方法更适合应用于基层实验室肺结核的诊断。
