title: [Utility value of a T-cell interferon-γ release assay based on recombinant Mycobacterium tuberculosis 11kD protein in the diagnosis of tuberculosis].
abstract: OBJECTIVE
  To evaluate the diagnostic efficiency of a T-cell interferon-γ release assay based on recombinant Mycobacterium tuberculosis (MTB) 11kD protein for diagnosing tuberculosis.
  
  
  METHODS
  This prospective study enrolled inpatients with suspected tuberculosis at PUMCH to examine the diagnostic sensitivity, specificity, predictive value (PV) and likelihood ratio (LR) of T-cell interferon-γ release assays based on recombinant MTB-11kD protein, early antigenic target-6 (ESAT-6) and culture filtrate protein-10 (CFP-10) peptides (T-SPOT. TB). Test results were compared with final clinical and microbiological diagnoses.
  
  
  RESULTS
  Among 151 inpatients with suspected tuberculosis, 33 (21.9%) were microbiologically or clinically diagnosed as tuberculosis and 107 (70.9%) ruled out. And the remaining 11 (7.3%) patients were clinically indeterminate. The sensitivities of recombinant MTB-11kD-ELISPOT assay and T-SPOT. TB were 60.6%and 81.8%respectively (P = 0.057).Whereas, the specificity of recombinant MTB-11kD-ELISPOT assay was significantly higher than that of T-SPOT. TB (84.1%vs 72.9%, P = 0.046). The parallel testing increased the sensitivity to 84.9% and serial testing increased the specificity to 86.9%.
  
  
  CONCLUSIONS
  The recombinant MTB-11kD-ELISPOT assay is more specific than T-SPOT. TB. And its combination with T-SPOT. TB may improve the diagnostic efficiency for tuberculosis.
authors.affiliation: Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China.
authors.forename: Lifan
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Email: liuxqpumch@126.com.
authors.forename: Xiaoqing
authors.initials: X
authors.lastname: Liu
authors.forename: Weiwei
authors.initials: W
authors.lastname: Gao
authors.forename: Weixin
authors.initials: W
authors.lastname: Du
authors.forename: Guozhi
authors.initials: G
authors.lastname: Wang
authors.forename: Guohua
authors.initials: G
authors.lastname: Deng
mesh_terms: D000328:Adult; D001426:Bacterial Proteins / Q000276:immunology; D058501:Enzyme-Linked Immunospot Assay / Q000379:methods*; D005260:Female; D006801:Humans; D007371:Interferon-gamma / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000276:immunology*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000276:immunology; D012680:Sensitivity and Specificity; D013601:T-Lymphocytes / Q000276:immunology; D014376:Tuberculosis / Q000175:diagnosis*
chemical_list: D001426:Bacterial Proteins; D011994:Recombinant Proteins; D007371:Interferon-gamma