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目的评价GeneXpert MTB/RIF系统在临床疑似结核病患者中的诊断价值。方法对临床疑似结核病患者的220份标本分别进行抗酸涂片镜检、结核分枝杆菌培养、鉴定及比例法药敏试验、GeneXpert MTB/RIF系统检测结核分枝杆菌及利福平敏感性。应用统计学方法分析GeneXpert MTB/RIF系统检测结果。结果 GeneXpert MTB/RIF系统与罗氏培养法检测结核分枝杆菌之间的差异无统计学意义(P>0.05),并且通过Kappa检验2种方法检测的结果,一致性较好(Kappa=0.944)。GeneXpert MTB/RIF系统与抗酸涂片镜检检测结核分枝杆菌之间的差异有统计学意义(P<0.05)。Kappa检验2种方法检测的结果,一致性一般(Kappa=0.726)。以结核培养为金标准,220份疑似结核病患者的标本中,GeneXpert MTB/RIF系统检测结核分枝杆菌的敏感度、特异度、阳性预测值、阴性预测值分别为96.92%、97.92%、95.45%、98.60%。结论 GeneXpert MTB/RIF系统在临床疑似结核病患者的诊断中具有重要价值。
Objective To evaluate the diagnostic value of GeneXpert MTB / RIF system in clinical suspected tuberculosis patients. Methods Anti-acid smear microscopy, culture and identification of Mycobacterium tuberculosis, and drug susceptibility testing by proportional method were performed on 220 specimens of suspected clinical TB patients. The sensitivity of Mycobacterium tuberculosis and rifampicin was tested by GeneXpert MTB / RIF system. Statistical analysis of GeneXpert MTB / RIF system test results was performed. Results There was no significant difference between GeneXpert MTB / RIF system and Mycobacterium tuberculosis detection by Roche culture method (P> 0.05). The Kappa test showed that the two methods had good agreement (Kappa = 0.944). The difference between GeneXpert MTB / RIF system and Mycobacterium smegmatis was statistically significant (P <0.05). Kappa test two methods test results, the general agreement (Kappa = 0.726). The sensitivity, specificity, positive predictive value and negative predictive value of GeneXpert MTB / RIF system for detection of Mycobacterium tuberculosis were 96.92%, 97.92% and 95.45%, respectively, in 220 samples of suspected tuberculosis patients with tuberculosis culture as the gold standard. , 98.60%. Conclusion The GeneXpert MTB / RIF system is of great value in the diagnosis of patients with suspected clinical TB.