恒温扩增法快速检测结核分枝杆菌复合群的临床应用

Clinical Application of Rapid Detection of Mycobacterium Tuberculosis Complex Group by Thermostatic Amplification Fluorescence Method

目的比较痰涂片、罗氏培养法和恒温扩增荧光法在快速检测临床标本中结核分枝杆菌的检测效果,分析恒温扩增荧光法在临床应用中的优势。方法选取2018年1月至2019年5月期间在惠州市结核病防治研究所结核科就诊的1000名肺结核患者作为研究对象,采集足量晨痰标本,同时采用痰涂片镜检法、罗氏培养法、恒温扩增荧光法进行结核杆菌检测。采用阳性率来评价检测方法的检测效果;采用Kappa值来评价恒温扩增荧光法与罗氏培养法的检测效果一致性。结果1000例肺结核患者的痰标本进行痰涂片法、罗氏培养法、恒温扩增荧光法的检测阳性率分别为44.7%、55.4%和70.3%;对恒温扩增荧光法和罗氏培养法的检测结果进行一致性检验,Kappa值为0.592(P﹤0.01)。结论恒温扩增荧光法检测肺结核患者痰标本的阳性率明显高于传统的涂片镜检法和罗氏培养法,且恒温扩增法与临床金标准罗氏培养法的检测结果具有中等程度的一致性。恒温扩增荧光法具有阳性率高、结果客观准确、操作简便、检测耗时短、操作风险低等优点,具有良好的临床应用价值。

Objective To compare the efficacy of sputum smear,Roche culture method and thermostatic amplification fluorescence method in the rapid detection of mycobacterium tuberculosis in clinical specimens,and to analyze the advantages of thermostatic amplification fluorescence method in clinical application.Methods 1000 tuberculosis patients treated in the tuberculosis department of Huizhou Tuberculosis Prevention and Treatment Institute from January 2018 to May 2019 were selected as the study subjects.Sufficient morning sputum specimens were collected.Meanwhile,sputum smear microscopy method,Roche culture method and thermostatic amplification fluorescence method were used to detect tuberculosis bacilli.The positive rate was used to evaluate the detection effects of these methods.Kappa value was used to evaluate the consistency of the detection results of thermostatic amplification fluorescence method and Roche culture method.Results The positive rates of sputum smear,Roche culture and thermostatic amplification fluorescence were 44.7%,55.4%and 70.3%respectively.The results of constant temperature amplification fluorescence method and Roche culture method were tested for consistency,and the Kappa value was 0.592(P﹤0.01).Conclusion The positive rate of sputum specimens detected by thermostatic amplification fluorescence method is significantly higher than that by traditional smear microscopy and Roche culture method,and the results of thermostatic amplification method and clinical gold standard Roche culture method have a moderate degree of consistency.Thermostatic amplification fluorescence method has the advantages of high positive rate,objective and accurate results,simple operation,short detection time,low operation risk and the like.Therefore,it has good clinical application value.