title: Enhanced serodiagnostic utility of novel Mycobacterium tuberculosis polyproteins.
abstract: OBJECTIVE
  The detection of Mycobacterium tuberculosis specific antibodies in human sera has been a rapid and important diagnostic aid for tuberculosis (TB) control and prevention. However, any single antigen is not enough to be used to cover the antibody profiles of all TB patients.
  
  
  METHODS
  Seven single antigens (38 kDa, ESAT-6, CFP10, Mtb8.4, MPT64, TB16.3 and Mtb8) were evaluated serodiagnostically. Two novel M. tuberculosis polyproteins, 38kD-ESAT6-CFP10 (38F) and Mtb8.4-MPT64-TB16.3-Mtb8 (64F), were expressed and the novel 38F-64F indirect ELISA assay used to analyze antibody responses to polyproteins in serum samples.
  
  
  RESULTS
  The sensitivity of the novel 38F-64F indirect ELISA alone was much higher than that of the sputum culture test (86.91% vs. 50.62%) and that of the sputum smear test (78.64% vs. 47.57%). The novel 38F-64F indirect ELISA had a sensitivity of 74.16% with sera from extrapulmonary TB patients and a sensitivity of 37.14% with sera from LTBI. The specificity of the novel 38F-64F indirect ELISA was 90.36% with the sera from healthy blood donors and 94.15% with the sera from non-TB patients.
  
  
  CONCLUSIONS
  The novel 38F-64F indirect ELISA assay had effective diagnostic performance and would make meaningful contribution to the diagnosis of TB disease in developing countries.
authors.affiliation: Department of Bio-diagnosis, Beijing Institute of Basic Medical Sciences, 27, Taiping Road, Beijing 100850, China.
authors.forename: Xiaoyan
authors.initials: X
authors.lastname: Feng
authors.forename: Bingshui
authors.initials: B
authors.lastname: Xiu
authors.forename: Kun
authors.initials: K
authors.lastname: Chen
authors.forename: Xiqin
authors.initials: X
authors.lastname: Yang
authors.forename: Hongtao
authors.initials: H
authors.lastname: Zhang
authors.forename: Jun
authors.initials: J
authors.lastname: Yue
authors.forename: Yaoju
authors.initials: Y
authors.lastname: Tan
authors.forename: Hongmin
authors.initials: H
authors.lastname: Li
authors.forename: Russell A
authors.initials: RA
authors.lastname: Nicholson
authors.forename: Albert W
authors.initials: AW
authors.lastname: Tam
authors.forename: Ping
authors.initials: P
authors.lastname: Zhao
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.forename: Jing
authors.initials: J
authors.lastname: Liu
authors.forename: Xiaoguo
authors.initials: X
authors.lastname: Song
authors.forename: Guohua
authors.initials: G
authors.lastname: Wang
authors.forename: Heqiu
authors.initials: H
authors.lastname: Zhang
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000942:Antigens, Bacterial / Q000276:immunology; D003906:Developing Countries; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000276:immunology*; D020815:Polyproteins / Q000276:immunology; D011993:Recombinant Fusion Proteins / Q000276:immunology; D012680:Sensitivity and Specificity; D012698:Serologic Tests; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; C505464:ESAT-6-CFP10 fusion protein; C510537:MPT64 protein, Mycobacterium tuberculosis; D020815:Polyproteins; D011993:Recombinant Fusion Proteins; C072681:Mycobacterium tuberculosis antigens