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目的探讨Gene Xpert~MTB/RIF(Xpert)、Hain Geno Type~MTBDR plus(Hain)和基因芯片技术在结核分枝杆菌(MTB)对利福平(RFP)耐药性检测中的应用价值。方法随机选289例患者的涂阳痰标本,每例标本分成3份,分别进行Xpert检测、罗氏培养和MTB DNA提取,MTB DNA分别用于Hain技术和基因芯片技术检测RFP耐药性,罗氏培养阳性菌株作比例法药物敏感性试验。3种快速分子药敏检测结果不一致者,进一步作DNA测序分析。结果 RFP耐药性结果以比例法为金标准,Xpert、Hain和基因芯片分别与之比较,灵敏度、特异度、准确度、阳性预测值(PPV)、阴性预测值(NPV)均无显著差异(P均>0.05,Kappa值均>0.75)。3种快速分子药敏检测RFP结果完全相同的277例(192例敏感,85例耐药),总符合率95.85%。结论 Xpert、Hain、基因芯片与比例法比较,MTB RFP耐药性检测差异均无统计学意义且结果具有较高的一致性。
Objective To investigate the value of Gene Xpert ~ MTB / RIF (Xpert), Hain Genotype ~ MTBDR plus (Hain) and gene chip technology in the detection of resistance to rifampicin (RFP) in Mycobacterium tuberculosis . Methods Sputum sputum samples of 289 patients were randomly selected. Each sample was divided into three groups. Xpert, Roche culture and MTB DNA extraction were performed respectively. MTB DNA was used to detect RFP resistance by Hain technique and gene chip technique. Roche culture Positive strains for proportional method of drug sensitivity test. Three kinds of rapid molecular susceptibility test results were inconsistent, further DNA sequencing analysis. Results The results of RFP resistance were based on the gold standard. There was no significant difference in sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) between Xpert, Hain and gene chip P> 0.05, Kappa value> 0.75). There were 277 RFP cases (192 sensitive and 85 resistant) with the same RFP results of the three rapid molecular tests, with a total coincidence rate of 95.85%. Conclusion Xpert, Hain, gene chip and ratio method, MTB RFP resistance test showed no significant difference and the results have a high consistency.