Huang T S, Liu Y C, Lin H H, Huang W K, Cheng D L
Section of Microbiology and Infectious Diseases, Veterans General Hospital-Kaohsiung, Taiwan, Republic of China.
J Clin Microbiol. 1996 Dec;34(12):3092-6. doi: 10.1128/jcm.34.12.3092-3096.1996.
Two commercial primer kits and detection systems, the Roche AMPLICOR MYCOBACTERIUM test and the Digene primer-probe kit with the SHARP Signal System, were compared to in-house PCR as well as standard culture techniques. For the 27 culture-positive specimens, the Roche AMPLICOR MYCOBACTERIUM test detected 20 specimens, the Digene system detected 19, and in-house PCR detected 21. Of the 86 culture-negative specimens, 13 were positive by the Roche AMPLICOR MYCOBACTERIUM test, 16 were positive by the Digene system, and 21 were positive by in-house PCR. When clinical situations were evaluated, 11 of 13 culture-negative Roche AMPLICOR MYCOBACTERIUM test-positive specimens, 10 of 16 culture-negative Digene system-positive specimens, and 13 of 21 culture-negative-in-house PCR-positive specimens were diagnosed as true-positive specimens. The sensitivities of Roche AMPLICOR MYCOBACTERIUM test, the Digene system, and in-house PCR were 73.81, 69.05, and 80.95%, and the specificities were 97.18, 91.55 and 88.73%, respectively. The positive predictive values were 93.94, 82.86, and 80.95%, and the negative predictive values were 86.25, 83.33, and 88.73%, respectively. For the commercial kits, the Roche AMPLICOR MYCOBACTERIUM test seems to be more sensitive and specific than the Digene system. However, the Roche AMPLICOR MYCOBACTERIUM test cannot be used on nonrespiratory specimens.
将两种商业引物试剂盒和检测系统，即罗氏AMPLICOR分枝杆菌检测试剂盒和带有SHARP信号系统的Digene引物-探针试剂盒，与内部聚合酶链反应（PCR）以及标准培养技术进行了比较。对于27份培养阳性标本，罗氏AMPLICOR分枝杆菌检测试剂盒检测出20份，Digene系统检测出19份，内部PCR检测出21份。在86份培养阴性标本中，罗氏AMPLICOR分枝杆菌检测试剂盒检测出13份阳性，Digene系统检测出16份阳性，内部PCR检测出21份阳性。在评估临床情况时，13份培养阴性但罗氏AMPLICOR分枝杆菌检测试剂盒阳性的标本中有11份、16份培养阴性但Digene系统阳性的标本中有10份以及21份培养阴性但内部PCR阳性的标本中有13份被诊断为真阳性标本。罗氏AMPLICOR分枝杆菌检测试剂盒、Digene系统和内部PCR的敏感性分别为73.81%、69.05%和80.95%，特异性分别为97.18%、91.55%和88.73%。阳性预测值分别为93.94%、82.86%和80.95%，阴性预测值分别为86.25%、83.33%和88.73%。对于商业试剂盒而言，罗氏AMPLICOR分枝杆菌检测试剂盒似乎比Digene系统更敏感、更具特异性。然而，罗氏AMPLICOR分枝杆菌检测试剂盒不能用于非呼吸道标本。
