title: Evaluation of QuantiFERON-TB Gold Plus for Detection of Mycobacterium tuberculosis infection in Japan.
abstract: Performance of interferon-γ (IFN-γ) release assays still needs to be improved. The data on the performance of QuantiFERON-TB Gold Plus (QFT-Plus), a new-generation of QFT assay are limited. This study evaluated the diagnostic performance of QFT-Plus, and compared to that of QuantiFERON-TB Gold In-Tube (QFT-GIT). Blood samples were collected from 162 bacteriologically confirmed tuberculosis (TB) patients and 212 Mycobacterium tuberculosis-uninfected volunteers; these samples were then tested with QFT-GIT and QFT-Plus. The IFN-γ concentration of QFT-Plus was lower than that of QFT-GIT in TB patients (p < 0.001). Receiver operating characteristic curves were compared between QFT-GIT and QFT-Plus. Both assays showed area under the curve values over 0.99 without significant difference. Using the conventional cut-off (0.35 IU/mL) for QFT-GIT, QFT-Plus had a lower sensitivity of 91.1% compared to 96.2% (p = 0.008) at its optimum cut-off (0.168 IU/mL) with the same specificity. Moreover, IFN-γ values were significantly reduced with age in QFT-GIT (p = 0.035) but not in QFT-Plus. The diagnostic performance of QFT-Plus was as accurate as that of QFT-GIT despite a lack of TB7.7 antigen and despite the decrease in quantitative values. However, the cut-off value for QFT-Plus should be considered independently from that of QFT-GIT to obtain the best sensitivity without compromising specificity.
authors.affiliation: Department of Mycobacterium Reference and Research, The Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Japan.|Department of Respiratory Medicine, Fukujuji Hospital, Japan Anti-Tuberculosis Association, Kiyose, Japan.|Department of Basic Mycobacteriology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
authors.forename: Lina
authors.initials: L
authors.lastname: Yi
authors.affiliation: Department of Respiratory Medicine, Fukujuji Hospital, Japan Anti-Tuberculosis Association, Kiyose, Japan.
authors.forename: Yuka
authors.initials: Y
authors.lastname: Sasaki
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization Tokyo National Hospital, Kiyose, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Nagai
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization Chiba Higashi National Hospital, Chiba, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Ishikawa
authors.affiliation: Department of Respiratory Medicine, Tokyo Metropolitan Tama Medical Centre, Fuchu, Japan.
authors.forename: Mikio
authors.initials: M
authors.lastname: Takamori
authors.affiliation: Department of Basic Mycobacteriology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.|Department of Respiratory Medicine, Tokyo Metropolitan Tama Medical Centre, Fuchu, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Sakashita
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization Ibaraki Higashi National Hospital, Ibaraki, Japan.
authors.forename: Takefumi
authors.initials: T
authors.lastname: Saito
authors.affiliation: Department of Respiratory Medicine, Nagasaki Genbaku Isahaya Hospital, Nagasaki, Japan.
authors.forename: Kiyoyasu
authors.initials: K
authors.lastname: Fukushima
authors.affiliation: Department of Mycobacterium Reference and Research, The Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Japan.
authors.forename: Yuriko
authors.initials: Y
authors.lastname: Igarashi
authors.affiliation: Department of Mycobacterium Reference and Research, The Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Japan.
authors.forename: Akio
authors.initials: A
authors.lastname: Aono
authors.affiliation: Department of Mycobacterium Reference and Research, The Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Japan.
authors.forename: Kinuyo
authors.initials: K
authors.lastname: Chikamatsu
authors.affiliation: Department of Mycobacterium Reference and Research, The Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yamada
authors.affiliation: Department of Mycobacterium Reference and Research, The Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Japan.
authors.forename: Akiko
authors.initials: A
authors.lastname: Takaki
authors.affiliation: Department of Mycobacterium Reference and Research, The Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Mori
authors.affiliation: Department of Mycobacterium Reference and Research, The Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Japan.|Department of Basic Mycobacteriology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Mitarai
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D059425:Interferon-gamma Release Tests / Q000379:methods*; D007564:Japan; D008297:Male; D008875:Middle Aged; D012372:ROC Curve; D012680:Sensitivity and Specificity; D014376:Tuberculosis / Q000175:diagnosis*; D055815:Young Adult