Objective To develop a rapid method for detecting Mycobacterium tuberculosis (MTB) resistance to Amikacin by phage amplified biologically (PhaB) assay and to evaluate its clinical application value. Methods The antimicrobial resistances in 103 MTB clinicai isolates to Amikacin were detected by phage amplified biologically (PhaB) assay, the results of which were compared with that detected by absolute concentration method. Amikacin resistances in those strains emerging inconsistent results by two mentioned methods were determined by the proportion method. Results Taking the results of the absolute concentration method system as the golden standard, the sensitivity, specificity as well as accuracy of the susceptibility tests to Amikacin detected by PhaB assay were 85.7％, 89.2％ and 87.4％ respectively. Inconsistent results between the PhaB method and the absolute concentration method were found in 13 isolates, in which 9 isolates by the proportion method were identical with PhaB assay. Conclusion The results of Amikacin susceptibility tests detected by PhaB assay have a high concordance with the results of the absolute concentration method. PhaB assay can be used for rapid screening of susceptibility tests for MTB.%目的 建立快速测定结核分枝杆菌丁胺卡那霉素耐药性的噬菌体生物扩增法,并探讨其在结核分枝杆菌丁胺卡那霉素耐药性测定中的应用价值.探讨噬菌体检测技术(PhaB)快速检测丁胺卡那霉素抗结核药物耐药性的可能性,分析其临床应用价值.方法 应用PhaB测定103株结核分枝杆菌(MTB)临床分离株对丁胺卡那霉素的耐药性,并与绝对浓度法药敏结果比较,对两法检测结果不符的菌株进行比例法测定.结果 以绝对浓度法药敏结果为判断标准,则PhaB检测丁胺卡那霉素的敏感度、特异度及准确性分别为85.7%、89.2%和87.4%;共有13株菌株PhaB法药敏结果与绝对浓度法检测结果不符,其中9株PhaB法药敏结果与比例法相符合.结论 PhaB检测丁胺卡那霉素药敏结果与绝对浓度法有较高的符合率,可作为MTB耐药性的快速筛选方法.
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