Vuorinen P, Miettinen A, Vuento R, Hällström O
Department of Clinical Microbiology, Tampere University Hospital, Finland.
J Clin Microbiol. 1995 Jul;33(7):1856-9. doi: 10.1128/jcm.33.7.1856-1859.1995.
Two hundred and fifty-six sputum, bronchoalveolar lavage, and bronchial and tracheal aspirate specimens from 243 patients were tested for the presence of Mycobacterium tuberculosis complex by auramine fluorochrome staining, rRNA target amplification (Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test [AMTD]), and PCR (Roche Amplicor Mycobacterium Tuberculosis Test [Amplicor PCR]. The results were compared with those of conventional Löwenstein-Jensen tube culture and BACTEC radiometric liquid culture. A total of 26 specimens from 18 patients were culture positive for M. tuberculosis. In addition, seven specimens were positive by staining and by culture for other Mycobacterium species but negative by nucleic acid amplification methods and were not included in the comparison. When compared with that for culture, the sensitivities of the techniques were as follows: for staining, 80.8%; for Gen-Probe AMTD, 84.6%; and for Roche Amplicor PCR, 84.6%. The specificities were 99.1, 98.7, and 99.1%, respectively. After resolution of discrepant results by review of the patients' clinical data, 29 specimens from 21 patients were considered positive, and the overall sensitivities, specificities, and positive and negative predictive values were 89.7, 100, 100, and 98.7% for culture; 75.9, 99.5, 95.7, and 96.9% for staining; 86.2, 100, 100, and 98.2% for Gen-Probe AMTD; and 82.8, 100, 100, and 97.9% for Roche Amplicor PCR, respectively. It is concluded that both nucleic acid amplification methods are rapid, sensitive, and specific methods for the detection of M. tuberculosis in respiratory specimens.
对来自243例患者的256份痰液、支气管肺泡灌洗以及支气管和气管吸出物标本，采用金胺荧光染色、rRNA靶标扩增（Gen-Probe结核分枝杆菌扩增直接试验[AMTD]）和PCR（罗氏Amplicor结核分枝杆菌检测[Amplicor PCR]）检测结核分枝杆菌复合群的存在。将结果与传统的罗-琴管培养和BACTEC放射性液体培养结果进行比较。共有来自18例患者的26份标本培养出结核分枝杆菌阳性。此外，7份标本经染色和培养对其他分枝杆菌属呈阳性，但核酸扩增方法呈阴性，未纳入比较。与培养相比，各技术的敏感性如下：染色为80.8%；Gen-Probe AMTD为84.6%；罗氏Amplicor PCR为84.6%。特异性分别为99.1%、98.7%和99.1%。通过复查患者临床资料解决不一致结果后，来自21例患者的29份标本被视为阳性，培养的总体敏感性、特异性、阳性和阴性预测值分别为89.7%、100%、100%和98.7%；染色为75.9%、99.5%、95.7%和96.9%；Gen-Probe AMTD为86.2%、100%、100%和98.2%；罗氏Amplicor PCR为82.8%、100%、100%和97.9%。结论是，两种核酸扩增方法都是检测呼吸道标本中结核分枝杆菌的快速、敏感和特异的方法。
