Gen-Probe结核菌直接检测法初始版本与新版本在呼吸道和非呼吸道标本中直接检测结核分枝杆菌的比较评估
Comparative evaluation of initial and new versions of the Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test for direct detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens.
作者信息
Gamboa F, Fernandez G, Padilla E, Manterola J M, Lonca J, Cardona P J, Matas L, Ausina V
机构信息
Servicio de Microbiologia, Hospital Universitario Germans Trias i Pujol, Barcelona, Spain.
出版信息
J Clin Microbiol. 1998 Mar;36(3):684-9. doi: 10.1128/JCM.36.3.684-689.1998.
We evaluated the initial version of the Amplified Mycobacterium Tuberculosis Direct Test (Gen-Probe) (AMTDT 1) and the new version of AMTDT (AMTDT 2) for the detection of Mycobacterium tuberculosis directly from respiratory and nonrespiratory samples and compared the results with those of culture and staining methods. The assays were applied to 410 respiratory and 272 nonrespiratory samples collected from 515 patients. The combination of the culture results and clinical diagnosis was considered to be the "gold standard." Ninety-five respiratory specimens were collected from 67 patients with a diagnosis of pulmonary tuberculosis (TB) and 68 nonrespiratory specimens were collected from 61 patients with a diagnosis of extrapulmonary TB. With respiratory specimens, the sensitivity, specificity, and positive and negative predictive values were 83, 100, 100, and 96%, respectively, for AMTDT 1 and 94.7, 100, 100, and 98.4%, respectively, for AMTDT 2. With nonrespiratory specimens, the sensitivity, specificity, and positive and negative predictive values were 83, 100, 100, and 94%, respectively, for AMTDT 1 and 86.8, 100, 100, and 98.4%, respectively, for AMTDT 2. The overall results of AMTDT 1 and AMTDT 2 were concordant for 97% (661 of 682) of the samples. Statistically significant differences in sensitivities were found between AMTDT 1 and AMTDT 2 with respiratory specimens. It was concluded that although both nucleic acid amplification methods are rapid, sensitive, and specific for the detection of M. tuberculosis complex in all types of clinical samples, AMTDT 2 appeared to be more sensitive than AMTDT 1 when applied to smear-negative specimens. In contrast AMTDT 2 is more susceptible than AMTDT 1 to inhibitory substances in the amplification reaction. The turnaround time of AMTDT 2 is shorter (3.5 h) than that for AMTDT 1 (5 h).
我们评估了结核分枝杆菌直接扩增检测法（基因探针公司）的初始版本（AMTDT 1）和新版本（AMTDT 2），用于直接从呼吸道和非呼吸道样本中检测结核分枝杆菌，并将结果与培养和染色方法的结果进行比较。这些检测方法应用于从515名患者收集的410份呼吸道样本和272份非呼吸道样本。培养结果和临床诊断的组合被视为“金标准”。从67例诊断为肺结核（TB）的患者中收集了95份呼吸道标本，从61例诊断为肺外结核的患者中收集了68份非呼吸道标本。对于呼吸道标本，AMTDT 1的敏感性、特异性、阳性和阴性预测值分别为83%、100%、100%和96%，AMTDT 2分别为94.7%、100%、100%和98.4%。对于非呼吸道标本，AMTDT 1的敏感性、特异性、阳性和阴性预测值分别为83%、100%、100%和94%，AMTDT 2分别为86.8%、100%、100%和98.4%。AMTDT 1和AMTDT 2的总体结果在97%（682份样本中的661份）的样本中一致。在呼吸道标本中，AMTDT 1和AMTDT 2的敏感性存在统计学显著差异。得出的结论是，尽管两种核酸扩增方法对于检测所有类型临床样本中的结核分枝杆菌复合群都快速、灵敏且特异，但当应用于涂片阴性标本时，AMTDT 2似乎比AMTDT 1更灵敏。相比之下，AMTDT 2比AMTDT 1在扩增反应中更易受抑制物质的影响。AMTDT 2的周转时间（3.5小时）比AMTDT 1（5小时）短。
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