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目的比较结核分枝杆菌及利福平耐药快速检测技术(简称Xpert MTB/RIF)和达安实时定量PCR检测肺泡灌洗液中的结核杆菌DNA对肺结核的诊断和卫生经济学价值。方法招募2014年3月~2015年11月进入第四军医大学西京医院就诊的疑似肺结核的连续病例112例,收集肺泡灌洗液样本同时进行抗酸染色、MGIT960液体培养和药敏试验、Xpert MTB/RIF和达安实时定量PCR检测。结果 112例纳入的研究对象中经培养确诊的肺结核患者有53例,疑似的肺结核患者15例,非结核患者44例。以MGIT960液体培养为金标准,Xpert MTB/RIF与达安实时定量PCR的灵敏度差异无统计学意义(98.11%vs90.57%,P=0.205),两者的灵敏度均高于抗酸染色灵敏度58.49%(P<0.001);而若以临床诊断为参考标准,Xpert MTB/RIF的灵敏度则高于达安实时定量PCR,且差异有统计学意义(P=0.045)。而抗酸染色、达安实时定量PCR和Xpert MTB/RIF的特异性分别为99.73%、88.64%和95.45%,差异无统计学意义(P=0.184)。进行成本-效果分析,每检出1例肺结核行1次Xpert MTB/RIF的费用为1 033.85元,远远高于达安实时定量PCR费用196.49元。结论 Xpert MTB/RIF灵敏度高,操作更加简便快速且易于开展,并能同时检测利福平耐药性,可作为检测肺泡灌洗液中结核分枝杆菌DNA的首选方法。但达安实时定量PCR的检测成本较低,更加适用于低收入人群。
Objective To compare the diagnosis and health economics value of Mycobacterium tuberculosis and rifampicin rapid detection technology (Xpert MTB / RIF) and Daan real-time quantitative PCR in detecting pulmonary tuberculosis in bronchoalveolar lavage fluid. Methods A total of 112 consecutive cases of suspected pulmonary tuberculosis admitted to Xijing Hospital of the Fourth Military Medical University from March 2014 to November 2015 were enrolled in this study. The samples of BALF were collected for anti-acid staining, MGIT960 liquid culture and drug sensitivity test. Xpert MTB / RIF and Daan real-time quantitative PCR test. Results Of the 112 patients included in the study, 53 were diagnosed with pulmonary tuberculosis, 15 were suspected pulmonary tuberculosis, and 44 were non-tuberculosis. The sensitivity of Xpert MTB / RIF to Daan real-time PCR was 98.11% vs 90.57% (P = 0.205), the sensitivity of both was higher than that of acid-fast staining with the MGIT960 liquid culture as the gold standard % (P <0.001). However, the sensitivity of Xpert MTB / RIF was higher than that of Daan real-time PCR if the clinical diagnosis was the reference standard. The difference was statistically significant (P = 0.045). The specificities of acid-fast staining, Daan real-time PCR and Xpert MTB / RIF were 99.73%, 88.64% and 95.45%, respectively, with no significant difference (P = 0.184). For the cost-effectiveness analysis, the cost of 1 Xpert MTB / RIF per 1 tuberculosis detected was 1 033.85 yuan, much higher than Da’an’s real-time PCR cost of 196.49 yuan. Conclusions Xpert MTB / RIF has the advantages of high sensitivity, simple and rapid operation, easy operation and simultaneous detection of rifampicin resistance. It can be used as the first choice for detecting Mycobacterium tuberculosis DNA in bronchoalveolar lavage fluid. But Daan real-time quantitative PCR detection costs lower, more suitable for low-income people.