重组结核分枝杆菌ESAT6-CFP10和11kDa蛋白的动物效力分析  

Potencies of recombinant Mycobacterium tuberculosis ESAT6-CFP10 and 11kDa proteins in guinea pigs

作　　者：卢锦标[1] 都伟欣[1] 苏城[1] 沈小兵[1] 陈保文[1] 蒲江 赵爱华[1] LU Jin-biao;DU Wei-xin;SU Cheng;SHEN Xiao-bing;CHEN Bao-wen;PU Jiang;ZHAO Ai-hua(Division of Tuberculosis Vaccines and Allergen,National Institutes for Food and Drug Control,Key Laboratory of Research on Quality and Standardization of Biotech Product,Chinese Academy of Medical Sciences,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院结核病疫苗和过敏原产品室中国医学科学院生物技术产品检定方法及其标准化重点实验室,北京102629 [2]安徽智飞龙科马生物制药有限责任公司,安徽合肥230039

出　　处：《中国生物制品学杂志》2021年第6期704-708,共5页Chinese Journal of Biologicals

基　　金：中国医学科学院中央级公益性科研院所基本科研业务费(2019PT310024)。

摘　　要：目的比较重组结核分枝杆菌(Mycobacterium tuberculosis,Mtb)ESAT6-CFP10(简称EC)和11kDa蛋白对Mtb感染豚鼠的皮试反应差异。方法将Mtb H37Ra和卡介苗(BCG)分别致敏豚鼠5周后,每只豚鼠皮内分别注射0.25、0.5和1μg重组EC、11kDa蛋白及5 IU纯蛋白衍生物(purified Protein Derivative,PPD),比较24和48 h后的皮试反应大小。结果对Mtb致敏豚鼠,0.25、0.5和1μg剂量的重组EC和11kDa在24和48 h均呈强阳性皮试反应,且剂量-效应关系明显;相同剂量的重组EC和11kDa的皮试反应强度相当。对BCG致敏豚鼠,PPD皮试反应为强阳性,而不同剂量EC和11kDa皮试反应均为阴性。结论豚鼠模型上,重组EC和11kDa结合PPD皮试,可区分Mtb感染和BCG接种,且前两者检测效果相当。Objective To compare the skin test reactions of recombinant Mycobacterium tuberculosis(Mtb)ESAT6-CFP10(EC)and 11kDa proteins in guinea pigs.Methods Guinea pigs were injected intradermally with 0.25,0.5 and 1μg recombinant EC,11kDa protein and 5 IU purified protein derivative(PPD)of Mtb respectively 5 weeks after sensitization with either H37Ra or BCG,of which the skin test reactions were compared 24 and 48 h later.Results Both recombinant EC and 11kDa,at dosages of 0.25,0.5 and 1μg,showed dose-dependent strong positive skin reaction 24 and 48 h after injection in guinea pigs sensitized with Mtb.The skin reaction intensity of EC was equivalent to that of 11kDa protein.However,PPD showed strong positive skin reaction in guinea pigs sensitized with BCG,while EC and 11kDa protein at various dosages showed negative reaction.Conclusion Both recombinant EC and 11kDa protein,in combination with PPD skin test,may distinguish Mtb infection and BCG vaccination in guinea pigs,with a consistent detection efficiency.

关 键 词：结核分枝杆菌 ESAT6-CFP10 11kDa蛋白 豚鼠 感染 皮试试验 

分 类 号：R378.911[医药卫生—病原生物学]