基因芯片与线性探针技术检测涂阳肺结核患者痰标本MTB耐药性的价值

目的评价基因芯片技术与线性探针技术(GenoType MTBDRplus)快速检测MTB耐药性的临床应用价值。方法选取西安市胸科医院2017年4月至2018年8月住院治疗的493例涂阳肺结核患者作为研究对象,收集其痰标本,痰标本量均不少于2ml。每例患者用同一份痰标本分别进行基因芯片检测、线性探针检测和BACTEC MGIT 960液体培养(简称“MGIT 960液体培养”),同时对培养阳性且鉴定为MTB的临床分离株进行MGIT 960液体药物敏感性试验(简称“药敏试验”)。以MGIT 960液体药敏试验结果为参照标准,分析基因芯片技术及线性探针技术检测涂阳肺结核患者痰标本MTB利福平和异烟肼耐药性的效能。结果 454例研究对象同时具有3种药敏试验检测结果。以MGIT 960液体药敏试验结果为参照标准,基因芯片法和线性探针法检测涂阳肺结核患者痰标本MTB利福平耐药性的敏感度、特异度、Kappa值分别为89.0%(65/73)、96.1%(366/381)、0.82和90.4%(66/73)、96.1%(366/381)、0.83;检测涂阳肺结核患者痰标本MTB异烟肼耐药性的敏感度、特异度、Kappa值分别为80.2%(93/116)、96.7%(327/338)、0.80和81.9%(95/116)、97.0%(328/338)、0.82。454例涂阳肺结核患者痰标本中,453例应用2种分子生物学检测方法检测MTB利福平耐药性结果相同,符合率为99.8%;445例应用2种分子生物学方法检测MTB异烟肼耐药性结果相同,符合率为98.0%。结论基因芯片技术和线性探针技术(GenoType MTBDRplus)检测涂阳肺结核患者痰标本MTB利福平和异烟肼耐药性与MGIT 960液体药敏试验具有较高的一致性,二者均可为临床提供快速、特异的耐药检测结果。

Evaluation on the performance of gene chip and linear probe technique in detecting MTB drug resistance in sputum samples from smear-positive pulmonary tuberculosis patients

Objective To evaluate the clinical application value of gene chip technique and linear probe technique (MTBDRplus) in rapid detection of MTB drug resistance. Methods A total of 493 patients with smear-positive pulmonary tuberculosis who were hospitalized in Xi’an Chest Hospital between April 2017 to August 2018 were selected as subjects. The sputum samples with the amount larger than 2 ml were collected. Each sputum sample was examined by gene chip, MTBDRplus and BACTEC MGIT 960 (MGIT 960) techniques, respectively. Meanwhile, the clinical isolates positive in culture and identified as MTB were subjected to MGIT 960 liquid drug susceptibility test. The results of MGIT 960 drug susceptibility test were used as reference standard to evaluate the performance of gene chip technique and MTBDRplus in detecting MTB isoniazid and rifampicin resistance in sputum specimens from smear-positive pulmonary tuberculosis patients. Results A total of 454 cases had the complete susceptibility test results detected by the three detection methods. Based on the results of drug susceptibility test by MGIT 960 method as reference standard, the sensitivity, specificity, and Kappa value of gene chip technique and MTBDRplus for detecting rifampicin resistance were 89.0% (65/73), 96.1% (366/381) and 0.82 as well as 90.4% (66/73), 96.1% (366/381) and 0.83, respectively; the sensitivity, specificity, and Kappa value for detecting isoniazid resistance were 80.2% (93/116), 96.7% (327/338) and 0.80 as well as 81.9% (95/116), 97.0% (328/338) and 0.82, respectively. Among 454 samples of the rifampicin resistance results, 453 cases were detected as the same results using gene chip technique and MTBDRplus, with the coincidence rate of 99.8%; the isoniazid resistance results detected by the two methods were consistent in 445 cases, with the coincidence rate of 98.0%. Conclusion Gene chip technique and MTBDRplus are highly consistent with MGIT 960 drug susceptibility test in detecting MTB rifampicin and isoniazid resistance in sputum specimens from smear-positive pulmonary tuberculosis patients, and both of them can provide rapid and specific drug resistance results.