title: Clinical evaluation of the recombinant 38 kDa protein of Mycobacterium tuberculosis.
abstract: The diagnosis of tuberculosis remains among public health concerns due to shortcomings of the purified protein derivative (PPD). Recombinant truncated 38 kDa protein (rTPA38) of Mycobacterium tuberculosis was evaluated to screen new tuberculosis-specific tuberculin. 539 patients, 1133 healthy controls, and 55 guinea pigs were recruited to assess their sensitivity and specificity to rTPA38; 221 healthy controls, with negative responses to rTPA38 and PPD, were vaccinated with M. bovis BCG to determine their cross-reactions with M. bovis BCG. The Mantoux technique was adopted to perform skin tests. No difference in the sensitivity of skin tests was detected between rTPA38 and PPD (78.2% vs 83.4%), but there was a significant difference in the specificity of skin tests between rTPA38 and PPD (75.2% vs 47.0%). Compared to PPD, rTPA38 elicited low positive responses for those recruitments vaccinated with M. bovis BCG. The rTPA38 had significant skin reactions in M. tuberculosis-sensitized guinea pigs, and the opposite was true for both M. fortuitum- and M. kansasii-sensitized guinea pigs. These findings indicate that rTPA38 may have potential as a tuberculosis-specific skin test antigen.
authors.affiliation: The Second Affiliated Hospital of General Hospital, People's Liberation Army, Beijing, China. xwhe@sohu.com
authors.forename: Xiu-Yun
authors.initials: XY
authors.lastname: He
authors.forename: Yong-Ai
authors.initials: YA
authors.lastname: Luo
authors.forename: Xiao-Gang
authors.initials: XG
authors.lastname: Zhang
authors.forename: Yuan-Dong
authors.initials: YD
authors.lastname: Liu
authors.forename: Zhong-Yuan
authors.initials: ZY
authors.lastname: Wang
authors.forename: Feng-Zhi
authors.initials: FZ
authors.lastname: Luo
authors.forename: Ji-Ping
authors.initials: JP
authors.lastname: Zhang
authors.forename: Qing
authors.initials: Q
authors.lastname: Wang
authors.forename: Shi-Ming
authors.initials: SM
authors.lastname: Yan
authors.forename: Yan-Jun
authors.initials: YJ
authors.lastname: Wang
authors.forename: Long-Feng
authors.initials: LF
authors.lastname: Ma
authors.forename: Jia
authors.initials: J
authors.lastname: Guo
authors.forename: Ya-Jun
authors.initials: YJ
authors.lastname: Dong
authors.forename: Xiang-Yu
authors.initials: XY
authors.lastname: Huang
authors.forename: Yu-Hui
authors.initials: YH
authors.lastname: Zhuang
mesh_terms: D000818:Animals; D000942:Antigens, Bacterial / Q000276:immunology*; D006168:Guinea Pigs; D006801:Humans; D008074:Lipoproteins / Q000276:immunology*; D009163:Mycobacterium bovis / Q000276:immunology*; D009170:Nontuberculous Mycobacteria / Q000276:immunology; D011994:Recombinant Proteins / Q000276:immunology; D012680:Sensitivity and Specificity; D014373:Tuberculin / Q000276:immunology; D014374:Tuberculin Test / Q000379:methods*; D014376:Tuberculosis / Q000175:diagnosis* / Q000276:immunology
chemical_list: C075966:Ag38 antigen, Mycobacterium tuberculosis; D000942:Antigens, Bacterial; D008074:Lipoproteins; D011994:Recombinant Proteins; D014373:Tuberculin