Xpert MTB/RIF与传统方法在肺结核病诊断中的对比

目的 评价Xpert MTB/RIF在肺结核病诊断中的应用价值。方法 选取2016年1月—2018年5月陕西省结核病防治研究所和汉中市第二人民医院就诊的300例肺结核可疑症状者作为研究对象,同时应用痰涂片镜检、固体培养、比例法固体药敏试验、Xpert MTB/RIF对所有研究对象的同一份痰样本进行检测。计算并比较3种方法的阳性检出率。以临床诊断结果为标准,比较痰涂片镜检法、固体培养法和Xpert MTB/RIF检测结核分枝杆菌（Mycobacterium tuberculosis,MTB）的效能;以固体比例法药敏试验结果为标准,评价Xpert MTB/RIF检测利福平耐药性的效能。结果 在唾液痰标本中,Xpert MTB/RIF的阳性检出率为43.87%（43/98）,显著高于痰涂片镜检法的11.22%（11/98）和固体培养法的29.59%（29/98）,差异均有统计学意义（χ²=26.17,P<0.001;χ²=4.30,P=0.04）;在涂阴肺结核病患者中,Xpert MTB/RIF的阳性检出率为61.00%（61/100）,显著高于固体培养法的37.00%（37/100）,差异有统计学意义（χ²=11.53,P=0.001）。以临床诊断为标准,Xpert MTB/RIF的灵敏度和特异度分别为78.57%（154/196）、96.15%（100/104）,Kappa值为0.69。Xpert MTB/RIF的灵敏度显著高于痰涂片镜检法的48.97%（96/196）和固体培养法的63.27%（124/196）,差异均有统计学意义（χ²=37.15,P<0.001;χ²=11.13,P=0.001）。以固体比例法药敏试验结果为标准,Xpert MTB/RIF的灵敏度和特异度分别为78.26%（18/23）、98.12%（99/101）,Kappa值为0.80。结论 与传统方法相比Xpert MTB/RIF具有较高的灵敏度、特异度和阳性检出率,可用于肺结核病的早期快速诊断。

Comparison of Xpert MTB/RIF and traditional methods in the diagnosis of pulmonary tuberculosis

Objective To evaluate diagnostic value of Xpert MTB/RIF in the diagnosis of pulmonary tuberculosis.Methods A total of 300 pulmonary tuberculosis suspects were continuously recruited in Shaanxi Provincial Institute for Tuberculosis Control and Prevention and The Second People's Hospital of Hanzhong from January 2016 to May 2018, the specimens were detected by smear, solid culture, traditional drug susceptibility test and Xpert MTB/RIF at the same time. The positive detection rate of the 3 methods was calculated and compared. Based on the clinical diagnosis result, efficiency of smear, solid culture and Xpert MTB/RIF were compared in all patents; efficiency of Xpert MTB/RIF for rifampin resistance was evaluated according to traditional drug susceptibility testing.Results The positive detection rate of Xpert MTB/RIF (43.87%, 43/98) was significantly higher than that of smear(11.22%, 11/98) and solid culture(29.59%, 29/98) in Saliva sputum specimens (χ²=26.17, P<0.001; χ²=4.30, P=0.04). The positive detection rate of Xpert MTB/RIF (61.00%, 61/100) was significantly higher than that of solid culture (37.00%, 37/100) in smear negative patients of pulmonary tuberculosis (χ²=11.53, P=0.001). Using clinical diagnosis result as the gold standard, the sensitivity and specificity of Xpert MTB/RIF were 78.57%（154/196） and 96.15%（100/104）, respectively (Kappa value was 0.69). The sensitivities of Xpert MTB/RIF was significantly higher than that of smear (48.97%, 96/196) and solid culture (63.27%, 124/196) (χ²=37.15, P<0.001; χ²=11.13, P=0.001). Based on the result of traditional drug susceptibility test, the sensitivity and specificity of Xpert MTB/RIF were 78.26%（18/23） and 98.12%（99/101）, respectively (Kappa value was 0.80).Conclusion Compared with traditional methods, Xpert MTB/RIF has a higher sensitivity, specificity and positive detection rate for early rapid diagnosis of pulmonary tuberculosis.