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目的探讨Hain GenoType?MTBDR plus(Hain)和基因芯片技术检测结核分枝杆菌(MTB)异烟肼(INH)耐药性的应用价值。方法随机选取289例结核患者的涂阳痰标本,各分成2份,分别进行罗氏培养和MTB DNA提取,提取的MTB DNA分别用Hain和基因芯片技术检测INH耐药性,罗氏培养阳性菌株做比例法药物敏感性试验。统计数据采用SPSS13.0软件分析。结果 MTB INH耐药性以比例法为金标准,Hain和基因芯片的灵敏度、特异度、准确度、阳性预测值(PPV)、阴性预测值(NPV)分别为82.56%、97.54%、93.08%、93.42%、92.96%和80.23%、98.03%、92.73%、94.52%、92.13%,一致性较高(Kappa值均>0.75)。289例患者中,2种快速分子药敏方法检测MTB INH耐药性完全相同276例(208例为敏感,68例为耐药),符合率95.50%;8例Hain法INH耐药,其中1例KatG 315(AGC→ACC),2例KatG 315(AGC→ACA),5例inhA-8(T→C),而基因芯片法均为敏感;5例基因芯片法INH耐药,均为KatG 315(AGC→AAC),而Hain法均为敏感。结论与比例法比较,检测MTB INH耐药性Hain和基因芯片法具有较高一致性,二者均可为临床提供快速、特异、较灵敏的INH耐药性检测结果。2种方法均适用于结核病早期快速的INH耐药性检测,但对INH敏感菌应结合临床其他指标综合分析。
Objective To investigate the value of Hain GenoType ™ MTBDR plus (Hain) and gene chip technology for detecting isoniazid (INH) resistance in Mycobacterium tuberculosis (MTB). Methods A total of 289 smear-positive sputum specimens of tuberculosis patients were randomly divided into two groups. The specimens were respectively cultured in Roche and MTB DNA. MTB DNA was extracted and tested by Hain and GeneChip respectively. The proportion of positive Roche-producing strains Law drug sensitivity test. Statistics using SPSS13.0 software analysis. The sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of Hain and gene chip were 82.56%, 97.54% and 93.08%, respectively. 93.42%, 92.96% and 80.23%, 98.03%, 92.73%, 94.52% and 92.13%, respectively. The consistency was higher (Kappa value> 0.75). Of the 289 patients, 276 cases (208 were sensitive and 68 resistant) were MTB INH resistant, and the coincidence rate was 95.50%. Eight of them were resistant to HIN with INH resistance, of which 1 (AGC → ACC), 2 cases of KatG 315 (AGC → ACA) and 5 cases of inhA-8 (T → C), all of which were sensitive by gene chip method. 315 (AGC → AAC), while the Hain method is sensitive. Conclusion Compared with the proportional method, the detection of MTB INH resistance Hain and gene chip method has a high consistency, both of which can provide fast, specific and sensitive INH resistance test results. Both methods are suitable for rapid detection of INH resistance in early stage of tuberculosis, but INH-sensitive bacteria should be combined with other clinical indicators comprehensive analysis.