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目的评价氧化还原指示剂(CRI)法检测耐多药结核病(MDR-TB)和广泛耐药结核病(XDR-TB)的效能。方法由河南省疾病预防控制中心结核病参比实验室菌株库中抽取复苏成功的155株结核分枝杆菌,使用氧化还原指示剂法和固体比例法药敏试验,分别检测菌株对异烟肼、利福平、氧氟沙星、卡那霉素、卷曲霉素和阿米卡星的耐药性,以固体比例法药敏为标准,比较计算CRI法的符合率、灵敏度及特异性。结果 155株结核分枝杆菌中,固体比例法药敏试验检测耐多药为42株,广泛耐药为15株;CRI法检测耐多药结核分枝菌47株,符合率为94.2%,灵敏度为95.2%,特异性为93.8%;CRI法检测广泛耐药菌16株,符合率为98.1%,灵敏度为93.3%,特异性为98.6%。CRI检测方法相对于固体比例法,药敏、耐药率差异无统计学意义(P均>0.05),Kappa值均>0.75,有较好的一致性。结论氧化还原指示剂法与固体比例法比较有很好的符合率,且具有操作快速、简便的特点,可以作为检测耐多药和广泛耐药结核病的快速方法 。
Objective To evaluate the efficacy of redox indicator (CRI) in the detection of multidrug-resistant tuberculosis (MDR-TB) and XDR-TB (XDR-TB). Methods A total of 155 strains of Mycobacterium tuberculosis recovered successfully were collected from the database of tuberculosis reference laboratories of Henan Provincial Center for Disease Control and Prevention. The redox indicator method and solid ratio method were used to detect the isolates of isoniazid, Fuping, ofloxacin, kanamycin, capreomycin and amikacin drug resistance, solid ratio method of drug sensitivity as a standard, comparative calculation of CRI method coincidence rate, sensitivity and specificity. Results Among 155 strains of Mycobacterium tuberculosis, 42 strains were multidrug-resistant and 15 strains were extensively drug-resistant by solid ratio method. 47 strains of multidrug-resistant Mycobacterium tuberculosis were detected by CRI, the coincidence rate was 94.2% 95.2%, specificity was 93.8%; 16 strains of widely resistant bacteria were detected by CRI, the coincidence rate was 98.1%, the sensitivity was 93.3% and the specificity was 98.6%. There was no significant difference in drug susceptibility and drug resistance between the CRI assay and the solid ratio assay (P> 0.05). The Kappa values were all> 0.75, showing good agreement. Conclusion The redox indicator method has a good coincidence rate with the solid ratio method and has the advantages of quick and easy operation and can be used as a rapid method for detecting multidrug-resistant and drug-resistant tuberculosis.