title: The Direct Comparison of Two Interferon-gamma Release Assays in the Tuberculosis Screening of Japanese Healthcare Workers.
abstract: Objective Two interferon-gamma release assays (IGRAs), the QuantiFERON-TB Gold In-Tube (QFT-GIT) and T-SPOT.TB (T-SPOT), are commercially available. The agreement between the two IGRAs in the screening of healthcare workers (HCWs) for latent tuberculosis is not well known. Methods The QFT-GIT and T-SPOT tests were performed for the baseline tuberculosis screening of 654 HCWs who worked at Mie University Hospital in Japan. The results of the two tests were directly compared. Results Nineteen (2.9%), 28 (4.3%) and 33 (5.0%) of the 654 HCWs were found to be positive by the QFT-GIT, T-SPOT, and the QFT-GIT and/or T-SPOT methods using cut-off values of 0.35 IU/mL (QFT-GIT) and 6 spots (T-SPOT). After excluding 4 cases with indeterminate results, there were 14 concordant positive (2.2%), 618 concordant negative (95.1%), and 18 discordant (2.8%) results using the cut-off values of 0.35 IU/mL (QFT-GIT) and 6 spots (T-SPOT). The agreement of the two IGRAs was 97.2% (κ=0.595). When cut-off values of 0.35 IU/mL (QFT-GIT) and 8 spots (T-SPOT) were applied, there were 11 concordant positive (1.7%), 626 concordant negative (96.3%), and 13 discordant (2.0%) results, with 98.0% agreement (κ=0.618). When the borderline criteria for the QFT-GIT (0.1 to <0.35 IU/mL) and T-SPOT (5-7 spots) were applied, there were 11 concordant positive (1.7%), 11 concordant borderline (1.7%), 586 concordant negative (90.2%), and 42 discordant (6.5%) results, with 93.5% agreement between the two methods (κ=0.538). Conclusion When standard cut-off values were used, the agreement between the two IGRAs in the tuberculosis screening of Japanese HCWs was moderate to high. Importantly, some HCWs showed discordant results, especially those whose results were in the borderline zones.
authors.affiliation: Department of Patient Safety and Infection Control, Mie University Hospital, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Tanabe
authors.forename: Akiko
authors.initials: A
authors.lastname: Nakamura
authors.forename: Akie
authors.initials: A
authors.lastname: Arai
authors.forename: Daisuke
authors.initials: D
authors.lastname: Yamasaki
authors.forename: Kyoko
authors.initials: K
authors.lastname: Hirano
authors.forename: Tetsu
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Osamu
authors.initials: O
authors.lastname: Taguchi
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Kaneko
authors.forename: Masaaki
authors.initials: M
authors.lastname: Ito
mesh_terms: D000328:Adult; D005076:Exanthema; D005260:Female; D006282:Health Personnel; D006785:Hospitals, University; D006801:Humans; D059425:Interferon-gamma Release Tests / Q000379:methods*; D007564:Japan; D055985:Latent Tuberculosis / Q000175:diagnosis*; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014374:Tuberculin Test / Q000379:methods*