title: Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in China.
abstract: OBJECTIVE
  To evaluate the performance of three interferon-gamma release assay (IGRA) kits in detecting Mycobacterium tuberculosis infection in China.
  
  
  METHODS
  A multicenter clinical trial was used to compare the effectiveness and application of the three kits. A total of 1026 participants were enrolled at three hospitals, including 597 tuberculosis (TB) patients diagnosed clinically (517 patients with pulmonary TB and 80 patients with extrapulmonary TB) and 429 negative controls (244 patients with pulmonary disease but not TB, or with non-tuberculosis mycobacterial lung diseases, and 185 healthy people). Detection performance indicators including sensitivity, specificity, and the Youden index (YI) were used to evaluate performance.
  
  
  RESULTS
  Through bacterial culture evaluation, 224 of the 517 pulmonary TB patients were positive and all 429 negative controls were negative. When the gold standard bacterial methods were used, the sensitivity, specificity, and YI were 89.7% (201/224), 91.1% (391/429), and 0.81 for T-SPOT.TB, 86.2% (193/224), 87.2% (374/429), and 0.73 for QB-SPOT, and 83.9% (188/224), 88.6% (380/429), and 0.73 for TB-IGRA, respectively. There were no significant differences in the sensitivity and specificity of the three kits.
  
  
  CONCLUSIONS
  The results showed that the three kits had very high sensitivity and specificity and exhibited a good performance for the detection of M. tuberculosis infection.
authors.affiliation: State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Qiu
authors.affiliation: Department of Physiology, Xiangya School of Medicine, Central South University, Changsha, Hunan 410078, China.
authors.forename: Yansen
authors.initials: Y
authors.lastname: Wang
authors.affiliation: State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, China; Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China.
authors.forename: Nan
authors.initials: N
authors.lastname: Lin
authors.affiliation: Anhui Chest Hospital, Hefei, Anhui Province, China.
authors.forename: Mingxiang
authors.initials: M
authors.lastname: Huang
authors.affiliation: Hunan Chest Hospital, Changsha, Hunan Province, China.
authors.forename: Yunhong
authors.initials: Y
authors.lastname: Tan
authors.affiliation: Fuzhou Pulmonary Hospital, Fuzhou, Fujian Province, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Wang
authors.affiliation: State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, China; Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Jiang
authors.affiliation: State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, China; Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China.
authors.forename: Haican
authors.initials: H
authors.lastname: Liu
authors.affiliation: State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, China; Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China.
authors.forename: Jiao
authors.initials: J
authors.lastname: Liu
authors.affiliation: State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, China; Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China.
authors.forename: Jingrui
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Anhui Chest Hospital, Hefei, Anhui Province, China.
authors.forename: Jue
authors.initials: J
authors.lastname: Wang
authors.affiliation: Hunan Chest Hospital, Changsha, Hunan Province, China.
authors.forename: Xinchan
authors.initials: X
authors.lastname: Chen
authors.affiliation: Fuzhou Pulmonary Hospital, Fuzhou, Fujian Province, China.
authors.forename: Dongping
authors.initials: D
authors.lastname: Wang
authors.affiliation: State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, China; Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China.
authors.forename: Guilian
authors.initials: G
authors.lastname: Li
authors.affiliation: Anhui Chest Hospital, Hefei, Anhui Province, China.
authors.forename: Zhongnan
authors.initials: Z
authors.lastname: Chen
authors.affiliation: Hunan Chest Hospital, Changsha, Hunan Province, China.
authors.forename: Lishui
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Hunan Chest Hospital, Changsha, Hunan Province, China.
authors.forename: Dixun
authors.initials: D
authors.lastname: Bao
authors.affiliation: State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, China; Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China.
authors.forename: Lili
authors.initials: L
authors.lastname: Zhao
authors.affiliation: Department of Physiology, Xiangya School of Medicine, Central South University, Changsha, Hunan 410078, China. Electronic address: guanchaxiang@csu.edu.cn.
authors.forename: Chaxiang
authors.initials: C
authors.lastname: Guan
authors.affiliation: State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, China; Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China. Electronic address: wankanglin@icdc.cn.
authors.forename: Kanlgin
authors.initials: K
authors.lastname: Wan
mesh_terms: D000328:Adult; D000368:Aged; D002681:China / Q000453:epidemiology; D005260:Female; D006801:Humans; D007371:Interferon-gamma / Q000378:metabolism; D059425:Interferon-gamma Release Tests / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis; D019982:Organizational Case Studies; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014376:Tuberculosis / Q000175:diagnosis* / Q000453:epidemiology*
chemical_list: D011933:Reagent Kits, Diagnostic; D007371:Interferon-gamma
keywords: China; Diagnosis; Evaluation; Interferon-gamma release assay; Tuberculosis