Clinical evaluation of the roche AMPLICOR PCR Mycobacterium tuberculosis test for detection of M-tuberculosis in respiratory specimens
Clinical evaluation of the roche AMPLICOR PCR Mycobacterium tuberculosis test for detection of M-tuberculosis in respiratory specimens
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DOI：
10.1128/jcm.34.5.1083-1085.1996
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发表时间：
1996-05-01
影响因子：
9.4
通讯作者：
Woods, GL
中科院分区：
文献类型：
--
作者：
Bergmann, JS;Woods, GL
为评价罗氏结核分枝杆菌试验(Amplicor MTB)诊断肺结核的可靠性，对502例患者的956份呼吸道标本进行了检测，并与培养和病史结果进行了比较。在135份培养阳性的标本中，31名患者的61份标本中长出了结核分支杆菌。52份标本涂片抗酸细菌(AFB)阳性；其中41份标本分离出结核分枝杆菌。在初始检测中，Amplicor MTB法与培养法相比，敏感性和特异性分别为78.7%和99.3%。在消除差异后(通过回顾病史)，Amplicor MTB检测的敏感性、特异性、阳性预测值和阴性预测值分别为79.4、99.6、92.6和98.6%。来自2名无临床证据的患者的两份标本为Amplicor MTB阳性和培养的禽分枝杆菌复合体阳性。对于AFB涂片阳性标本，Amplicor MTB的敏感性、特异性、阳性预测值和阴性预测值分别为97.6%、100%、100%和90.9%。对于AFB涂片阴性标本，Amplicor MTB的敏感性、特异性、阳性预测值和阴性预测值分别为40.0、99.5、69.2和98.7%。我们的结果支持在呼吸道标本AFB涂片阳性的患者中使用Amplicor MTB快速诊断结核病。对于AFB涂片阴性标本，还需要进一步的研究来确定这种检测方法的最具临床相关性和成本效益。
The reliability of the Roche AMPLICOR Mycobacterium tuberculosis test (AMPLICOR MTB) for the diagnosis of pulmonary tuberculosis was evaluated by testing 956 respiratory specimens from 502 patients and comparing results with results by culture and medical history. Of those 135 specimens that were culture positive for mycobacteria, 61 specimens from 31 patients grew M. tuberculosis. Fifty-two specimens were smear positive for acid-fast bacteria (AFB); M. tuberculosis was isolated from 41 of these specimens. On initial testing, the sensitivity and specificity of the AMPLICOR MTB assay, compared with culture, were 78.7 and 99.3%, respectively. After resolution of discrepancies (by review of medical history), the sensitivity, specificity, and positive and negative predictive values of the AMPLICOR MTB assay were 79.4, 99.6, 92.6, and 98.6%, respectively. Two specimens from two patients with no clinical evidence of tuberculosis were AMPLICOR MTB positive and culture positive for Mycobacterium avium complex. For AFB smear-positive specimens, the sensitivity, specificity, and positive and negative predictive values of AMPLICOR MTB were 97.6, 100, 100, and 90.9%, respectively. For AFB smear-negative specimens, the sensitivity, specificity, and positive and negative predictive values of AMPLICOR MTB were 40.0, 99.5, 69.2, and 98.7%, respectively. Our results support the use of AMPLICOR MTB for rapid diagnosis of tuberculosis in patients whose respiratory specimens are AFB smear positive. Further studies are needed to determine the most clinically relevant and cost-effective use of this assay with AFB smear-negative specimens.