title: Evaluation of a domestic interferon-gamma release assay for detecting Mycobacterium tuberculosis infection in China.
abstract: Interferon-gamma release assays (IGRAs) have been demonstrated to be useful in the diagnosis of Mycobacterium tuberculosis (MTB) infection. However, IGRAs have not been recommended for clinical usage in most low-income countries due to the shortage of clinical data available resulting from their high test cost. Recently, a cheaper domestic TB-IGRA was approved in China. In this study, we compared TB-IGRA with QuantiFERON-TB Gold In-Tube (QFT-GIT) for MTB infection diagnosis in 253 active TB patients, 48 non-TB lung disease patients, 115 healthcare workers and 216 healthy individuals. The proportion of positive TB-IGRA results in active TB patients, patients with non-TB lung disease, healthcare workers and healthy individuals was 88.3%, 27.1%, 40.9% and 17.6%, respectively, which was similar to the results of QFT-GIT, with an overall agreement of 95% (κ = 0.89) and a high correlation between their responses (r = 0.85, p < 0.001) being observed. In conclusion, the TB-IGRA has comparable clinical performance with QFT-GIT.
authors.affiliation: State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, Fujian, 361102, PR China; National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Life Science, Xiamen University, Xiamen, Fujian, 361102, PR China.
authors.forename: Yongliang
authors.initials: Y
authors.lastname: Liu
authors.affiliation: State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, Fujian, 361102, PR China; National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Life Science, Xiamen University, Xiamen, Fujian, 361102, PR China.
authors.forename: Mingzhan
authors.initials: M
authors.lastname: Ou
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Life Science, Xiamen University, Xiamen, Fujian, 361102, PR China; Xiamen Center for Disease Control and Prevention, Xiamen, Fujian, 361021, PR China.
authors.forename: Shuizhen
authors.initials: S
authors.lastname: He
authors.affiliation: Third People's Hospital of Kunming City, Kunming, Yunnan, 650041, PR China.
authors.forename: Xiaofei
authors.initials: X
authors.lastname: Li
authors.affiliation: State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, Fujian, 361102, PR China; National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Life Science, Xiamen University, Xiamen, Fujian, 361102, PR China.
authors.forename: Yanyan
authors.initials: Y
authors.lastname: Lin
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Life Science, Xiamen University, Xiamen, Fujian, 361102, PR China.
authors.forename: Junhui
authors.initials: J
authors.lastname: Xiong
authors.affiliation: State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, Fujian, 361102, PR China; National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Life Science, Xiamen University, Xiamen, Fujian, 361102, PR China.
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
authors.affiliation: State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, Fujian, 361102, PR China; National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Life Science, Xiamen University, Xiamen, Fujian, 361102, PR China. Electronic address: sxge@xmu.edu.cn.
authors.forename: Shengxiang
authors.initials: S
authors.lastname: Ge
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood; D016022:Case-Control Studies; D002681:China; D005260:Female; D054884:Host-Pathogen Interactions; D006801:Humans; D007371:Interferon-gamma / Q000097:blood*; D059425:Interferon-gamma Release Tests; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000276:immunology / Q000472:pathogenicity*; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D014376:Tuberculosis / Q000097:blood / Q000175:diagnosis* / Q000276:immunology / Q000382:microbiology; D055815:Young Adult
chemical_list: D015415:Biomarkers; C573415:IFNG protein, human; D007371:Interferon-gamma
keywords: IGRAs; MTB infection; Performance; TB-IGRA