title: Evaluation of a novel fusion protein antigen for rapid serodiagnosis of tuberculosis.
abstract: 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. In this study, a novel fusion protein was constructed using gene splicing by overlap extension (SOEing), and then the antibody level against it in 171 TB patients and 86 controls was evaluated by enzyme-linked immunosorbent assay. Compared with the three individual antigen (16 kDa: sensitivity 19.9%, specificity 96.5%; MPT64: sensitivity 75.4%, specificity 34.9%; 38 kDa: sensitivity 33.3%, specificity 83.7%), the fusion protein antigen (sensitivity 42.1%, specificity 89.5%) gave the best diagnostic performance with the largest receiver operating characteristic curve area 0.656 (95% confidence interval [CI], 0.590-0.721; P<0.01). These results suggested that the novel fusion protein antigen successfully constructed by gene SOEing provided the improved diagnostic performance for TB, and other mycobacterial multiepitope fusion proteins may also be worthy of investigation for further enhancing the detection sensitivity.
authors.affiliation: The First Affiliated Hospital of Zhengzhou University, Institute of Clinical Medical Research of Henan Universities, Zhengzhou, PR China.
authors.forename: Zhe
authors.initials: Z
authors.lastname: Cheng
authors.forename: Jun-Wei
authors.initials: JW
authors.lastname: Zhao
authors.forename: Zhan-Qiang
authors.initials: ZQ
authors.lastname: Sun
authors.forename: Yan-Zheng
authors.initials: YZ
authors.lastname: Song
authors.forename: Qing-Wen
authors.initials: QW
authors.lastname: Sun
authors.forename: Xiang-Yan
authors.initials: XY
authors.lastname: Zhang
authors.forename: Xue-Lian
authors.initials: XL
authors.lastname: Zhang
authors.forename: Hong-Hai
authors.initials: HH
authors.lastname: Wang
authors.forename: Xiao-Kui
authors.initials: XK
authors.lastname: Guo
authors.forename: Yu-Feng
authors.initials: YF
authors.lastname: Liu
authors.forename: Shu-Lin
authors.initials: SL
authors.lastname: Zhang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000942:Antigens, Bacterial / Q000737:chemistry / Q000235:genetics / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D004797:Enzyme-Linked Immunosorbent Assay; D000939:Epitopes / Q000032:analysis; D006801:Humans; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000276:immunology* / Q000302:isolation & purification; D016133:Polymerase Chain Reaction; D012372:ROC Curve; D011993:Recombinant Fusion Proteins / Q000096:biosynthesis / Q000737:chemistry / Q000235:genetics / Q000276:immunology*; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods*; D014376:Tuberculosis / Q000097:blood / Q000175:diagnosis*
chemical_list: D000942:Antigens, Bacterial; D000939:Epitopes; D011993:Recombinant Fusion Proteins