Clinical efficacy of the amplified Mycobacterium tuberculosis direct test for the diagnosis of pulmonary tuberculosis

Clinical efficacy of the amplified Mycobacterium tuberculosis direct test for the diagnosis of pulmonary tuberculosis
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DOI:
10.1164/ajrccm.153.5.8630609
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发表时间:
1996-05-01
影响因子:
24.7
通讯作者:
Catanzaro, A
Catanzaro, A
中科院分区:
医学1区
文献类型:
--
作者:
Bradley, SP;Reed, SL;Catanzaro, A

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扩增结核分枝杆菌直接检测(MTD)是一种基于核酸扩增技术的快速诊断检测,可直接用于处理的临床标本。我们通过比较MTD与抗酸涂片、分枝杆菌培养和临床评价的敏感性和特异性,评价MTD诊断肺结核的临床实用性。该研究包括来自421名患者的844份呼吸道标本,这些标本在6个月的时间内提交给我们的城市教学医院的微生物实验室。以培养法为对照,MTD的敏感性为93.6%,特异性为97.8%。MTD对既往未确诊的肺结核患者的敏感性(74.7%)高于已确诊并接受化疗的肺结核患者(29.2%),对涂阳肺结核患者的敏感性(95.5%)高于涂阴肺结核患者(70.0%)。在非结核分枝杆菌患者中有两个假阳性MTD结果,该人群的特异性为97.3%。我们的结论是,MTD,当与常规涂片和文化结合使用,是一个有用的快速诊断测试可疑肺结核。
The amplified Mycobacterium tuberculosis direct test (MTD) is a rapid diagnostic test based on a nucleic acid amplification technique, which can be used directly on processed clinical specimens. We evaluated the clinical utility of the MTD for diagnosing pulmonary tuberculosis by comparing the sensitivity and specificity of the test with acid-fast smear, mycobacterial culture, and clinical evaluation. The study included 844 respiratory tract specimens from 421 patients, which were submitted to the microbiology laboratory of our urban teaching hospital over a 6-mo period. Compared with culture, MTD had a sensitivity of 93.6% and a specificity of 97.8%. MTD was more sensitive in detecting pulmonary tuberculosis in patients with previously undiagnosed disease (74.7%) than in those with established disease receiving chemotherapy (29.2%), and in smear-positive (95.5%) than in smear-negative (70.0%) disease. There were two false positive MTD results in patients with nontuberculous mycobacteria, for a specificity in this population of 97.3%. We conclude that MTD, when used in conjunction with routine smear and culture, is a useful rapid diagnostic test for suspected pulmonary tuberculosis.