Diagnostic performance of amplified Mycobacterium tuberculosis direct test with cerebrospinal fluid, other nonrespiratory, and respiratory specimens
Diagnostic performance of amplified Mycobacterium tuberculosis direct test with cerebrospinal fluid, other nonrespiratory, and respiratory specimens
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使用脑脊液、其他非呼吸道和呼吸道标本进行扩增结核分枝杆菌直接检测的诊断性能
DOI：
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发表时间：
1996
影响因子：
9.4
通讯作者：
R. Weber
中科院分区：
文献类型：
--
作者：
G. Pfyffer;P. Kissling;Esther I. M. Jahn;H. Welscher;M. Salfinger;R. Weber
基因探针扩增结核分枝杆菌直接检测（MTD）适用于脑脊液（CSF）和其他各种非呼吸道标本。采用CSF的人工加标稀释系列进行标准化，改良MTD程序包括（i）将样本量增加10倍，（ii）用去污剂预处理标本，以及（iii）将扩增时间从2 h增加至3 h。在临床分枝杆菌学实验室中对MTD的性能进行了长期检测，共涉及998例患者的322份非呼吸道和1，117份呼吸道标本。将MTD结果与显微镜检查、培养、气液色谱-质谱法（仅CSF）分析结核硬脂酸和最终临床诊断结果进行比较。当MTD结果与解析数据进行比较时，非呼吸道标本MTD的灵敏度、特异性、阳性和阴性预测值分别为93.1%、97.7%、90.0%和98.5%，呼吸道标本MTD的灵敏度、特异性、阳性和阴性预测值分别为86.6%、96.4%、76.8%和98.1%。我们的数据表明，（i）MTD是一种快速检测M的稳健、高灵敏度和特异性技术。结论：（1）所有类型的临床标本中结核复合体的检出率无统计学差异（P > 0.005）;（2）与呼吸道标本相比，非呼吸道标本的灵敏度和特异性无统计学差异（P > 0.005）;（3）重复所有MTD，其结果在30，000和200，000相对光单位之间，将有助于防止大量假阳性，从而提高检测特异性。
The Gen-Probe Amplified Mycobacterium tuberculosis Direct Test (MTD) was adapted to be used for cerebrospinal fluid (CSF) and a large variety of other nonrespiratory specimens. Standardized with artificially spiked dilution series of CSF, the modified MTD procedure consists of (i) increasing the amount of sample 10-fold, (ii) pretreating the specimen with a detergent, and (iii) increasing the amplification time from 2 to 3 h. Performance of MTD in a clinical mycobacteriology laboratory was tested over an extended period of time, involving a total of 322 nonrespiratory as well as 1,117 respiratory specimens from 998 patients. Results from MTD were compared with those from microscopy, culture, analysis of tuberculostearic acid by gas-liquid chromatography-mass spectrometry (CSF only), and the final clinical diagnosis. When MTD results were compared with resolved data, the sensitivity, specificity, and positive and negative predictive values for MTD were 93.1, 97.7, 90.0, and 98.5%, respectively, for nonrespiratory specimens and 86.6, 96.4, 76.8, and 98.1%, respectively, for respiratory specimens. Our data demonstrate that (i) MTD is a robust, highly sensitive and specific technique for the rapid detection of M. tuberculosis complex in all types of clinical specimens, (ii) there was no statistically significant difference (P > 0.005) in sensitivity and specificity for nonrespiratory compared with respiratory specimens, and (iii) repeating all MTDs which yield a result between 30,000 and 200,000 relative light units would help prevent a large number of false positives and, thus, enhance test specificity.