Hu Zhong-Yi, Jin An-Jia, Chen Hui-Ping, Cui Zhen-Ling, Jing Ling-Jie, Wang Jie, Weng Xin-Hua
Basic Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Shanghai 200433, China.
Zhonghua Jie He He Hu Xi Za Zhi. 2004 Dec;27(12):811-4.
To set up a rapid detection method for rifampin susceptibility with phage amplified biologically (PhaB) assay and to evaluates its value in the detection of rifampin resistance in clinical isolates of Mycobacterium tuberculosis.
The assay was established to detect rifampin resistance in 524 clinical isolates of Mycobacterium tuberculosis, and the result was compared to that of the absolute concentration method. The minimum inhibitory concentration (MIC) was detected by BACTEC MGIT 960 method for the discrepant isolates.
Rifampin susceptibility results were available for 524 strains of Mycobacterium tuberculosis. A total of 223 strains were found to be rifampin resistant and 301 strains were rifampin susceptible detected by PhaB assay, but 211 and 313 strains were respectively found to be rifampin resistant and susceptible by conventional methods. There were 198 and 288 rifampin resistant and susceptible strains both detected by the two methods. The drug susceptibility of 35 strains was the same in 38 discrepant isolates by the PhaB assay and absolute concentration method. The sensitivity, specificity, positive and negative predictive values as well as the overall accuracy for the PhaB assay was 93.8%, 92.0%, 88.8%, 95.7% and 92.7% respectively if the judgment standard was adopted by conventional methods.
The result of PhaB assay was available within 2 days. This method, which is simple and does not need special equipment, can be used for rapid screening for rifampin resistance from Mycobacterium tuberculosis.
建立噬菌体生物扩增法（PhaB）快速检测利福平敏感性的方法，并评估其在检测结核分枝杆菌临床分离株利福平耐药性中的价值。
建立该检测方法以检测524株结核分枝杆菌临床分离株的利福平耐药性，并将结果与绝对浓度法的结果进行比较。对结果不一致的分离株采用BACTEC MGIT 960法检测最低抑菌浓度（MIC）。
524株结核分枝杆菌获得了利福平敏感性结果。PhaB法检测发现共有223株利福平耐药，301株利福平敏感，但传统方法分别检测出211株利福平耐药和313株利福平敏感。两种方法均检测出198株利福平耐药菌株和288株利福平敏感菌株。PhaB法与绝对浓度法检测的38株结果不一致的分离株中，35株的药敏结果相同。若采用传统方法的判断标准，PhaB法的敏感性、特异性、阳性预测值、阴性预测值及总准确率分别为93.8%、92.0%、88.8%、95.7%和92.7%。
PhaB法在2天内可获得结果。该方法简单且无需特殊设备，可用于快速筛查结核分枝杆菌的利福平耐药性。
