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GeneXpert MTB/RIF、Gene Chip 技术和改良罗氏培养法在检测和药敏试验中的性能比较

Performance Comparison of GeneXpert MTB/RIF, Gene Chip Technology, and Modified Roche Culture Method in Detecting and Drug Susceptibility in Sputum.

机构信息

Medical Laboratory, Bishan District People's Hospital of Chongqing, Chongqing, China.

出版信息

Contrast Media Mol Imaging. 2022 Jul 18;2022:2995464. doi: 10.1155/2022/2995464. eCollection 2022.

Abstract

Our aim of this study was to observe and analyze the performance of the real-time fluorescence quantitative nucleic acid amplification detection of /rifampicin resistance (GeneXpert MTB/RIF), gene chip technology, and modified Roche culture method in detecting MTB in sputum submitted for inspection and drug susceptibility. Patients with smear-negative suspected pulmonary TB ( = 120) in our hospital were enrolled in this study using a random number table, and sputum samples submitted for inspection were tested by the GeneXpert MTB/RIF, gene chip technology, and modified Roche culture method. With clinical diagnosis as the gold standard, the performance (mainly sensitivity and specificity) of the above three detection methods in the diagnosis of MTB was compared. Next, the drug susceptibility test (DST) was carried out on sputum samples, tested positive by the three methods. With the solid culture results as the evaluation criteria, the performance of the three detection methods in the diagnosis MTB and DST was compared. When compared with the modified Roche culture method, the GeneXpert MTB/RIF had the highest positive rate and a shorter overall test duration ( < 0.05). In contrast with the gene chip technology, the GeneXpert MTB/RIF exhibited higher sensitivity and negative predictive value (NPV) and lower specificity, accuracy, positive predictive value (PPV), and Kappa value ( < 0.05). According to analysis of the diagnostic performance of the three detection methods, GeneXpert MTB/RIF displayed the highest diagnostic sensitivity, ideal predictive values, and the highest similarity with clinical diagnosis in results ( < 0.05). The detection of susceptibility to isoniazid (INH) and RIF showed that the GeneXpert MTB/RIF and gene chip technology performed ideally in DST of MTB. In comparison with the modified Roche culture method, the GeneXpert MTB/RIF and gene chip technology have more prominent performance in detecting MTB and drug susceptibility. Besides, to further improve the accuracy of clinical diagnosis, various molecular biology detection methods can be combined to avoid delaying of the best time for the diagnosis and treatment of the disease.

摘要

本研究旨在观察和分析实时荧光定量核酸扩增检测(GeneXpert MTB/RIF)、基因芯片技术和改良罗氏培养法检测送检标本中结核分枝杆菌(MTB)及其药敏的性能。采用随机数字表法选取我院 120 例菌阴疑似肺结核(PTB)患者,分别采用 GeneXpert MTB/RIF、基因芯片技术和改良罗氏培养法检测送检标本,以临床诊断为金标准,比较上述 3 种检测方法对 MTB 诊断的效能(主要为敏感度和特异度)。进一步对 3 种方法检测阳性的标本进行药物敏感性检测(DST),以固体培养结果为评价标准,比较 3 种检测方法对 MTB 诊断和 DST 的效能。结果显示,与改良罗氏培养法比较,GeneXpert MTB/RIF 阳性率最高,总检测时间最短( < 0.05);与基因芯片技术比较,GeneXpert MTB/RIF 敏感度和阴性预测值(NPV)较高,特异度、准确性、阳性预测值(PPV)和 Kappa 值较低( < 0.05)。对 3 种检测方法的诊断效能进行分析,GeneXpert MTB/RIF 诊断 MTB 的敏感度最高,预测值理想,与临床诊断结果符合度最高( < 0.05)。对异烟肼(INH)和利福平(RIF)的药敏检测显示,GeneXpert MTB/RIF 和基因芯片技术在 MTB 的 DST 中表现理想。与改良罗氏培养法比较,GeneXpert MTB/RIF 和基因芯片技术在检测 MTB 及其药敏方面性能更优。此外,为了进一步提高临床诊断的准确性,可以联合各种分子生物学检测方法,避免延误疾病的最佳诊断和治疗时机。

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