噬菌体生物扩增法与改良罗氏比例法在结核杆菌药敏检测中的比较  

Comparison of phage-amplified biologically assay and conventional proportion method for the drug susceptibility testing in Mycobacterium tuberculosis

作　　者：彭丽[1] 陈保文[2] 沈小兵[2] 罗永艾[1] 王国治[2] 

机构地区：[1]重庆医科大学附属第一医院,重庆400016 [2]中国药品生物制品检定所,北京100050

出　　处：《中国防痨杂志》2005年第1期18-22,共5页Chinese Journal of Antituberculosis

摘　　要：目的　采用噬菌体生物扩增法 (PhaB法 )与传统比例法对结核分枝杆菌临床株进行利福平、异烟肼药物敏感试验 ,建立一种快速、敏感、特异、价廉的结核杆菌药敏试验方法。方法　分别采用噬菌体生物扩增法和改良罗氏比例法检测 5 2株结核分枝杆菌临床株对利福平、异烟肼的敏感性 ,将二者结果进行比较。结果　比例法检测结果为利福平耐药株的 34株中 ,噬菌体生物扩增法检测结果为 32株耐药 ,2株敏感 ;1 8株敏感株中噬菌体方法检测结果为 1 7株敏感 ,1株耐药。噬菌体方法检测结核菌对利福平的灵敏度为 94 .1 %(32 / 34) ,特异度为 94 .4 %(1 7/ 1 8) ,符合率为 94 .2 %(49/5 2 )。比例法检测为异烟肼耐药的 38株菌中 ,噬菌体方法检测 35株耐药 ,3株敏感 ;1 4株异烟肼敏感株中 ,噬菌体方法检测 1 1株敏感 ,3株耐药。噬菌体方法检测异烟肼敏感性的灵敏度为 92 .1 %(35 /38) ,特异度为 78.6 %(1 1 / 1 4 ) ,符合率为 88.5 %(46 / 5 2 )。结论　用噬菌体生物扩增法可快速、准确地检测结核分枝杆菌对利福平的敏感性 ,灵敏度高 ,与WHO推荐使用的比例法符合率高 ,可在 4 8h得到结果。异烟肼耐药性检测用噬菌体方法的特异度不如利福平 ,有待进一步探讨其原因。Objective To evaluate the value of phage-amplified biologically assay (PhaB),to set up a fast,sensitive,specific and inexpensive method for testing the drug susceptibility in Mycobacterium tuberculosis.Methods Fifty-two M.tuberculosis isolates were tested the susceptibility to rifampicin and isoniazid by using the PhaB assay and the conventional proportion method.Results Using the conventional proportion method as control,the sensitivity of testing using the PhaB assay were 94.1% (32/34) on rifampicin-resistant isolates,and 92.1% (35/38) on isoniazid-resistant isolates,the specificity were 94.4% (17/18) on rifampicin-sensitive isolates,and 78.6% (11/14) on isoniazid-sensitive isolates.The two susceptibility methods for rifampicin and isoniazid were 94.2% and 88.5% agreement respectively.Conclusion The PhaB assay could test correctly the drug susceptibility on the majority of M.tuberculosis isolates in 2 to 4 days.It might become a drug susceptibility testing with simplicity,high sensitivity,high specificity and low cost.

关 键 词：噬菌体 异烟肼 利福平 耐药 扩增 特异度 结核分枝杆菌 生物 比例法 敏感 

分 类 号：R446.5[医药卫生—诊断学]