title: Factors that Predict Negative Results of QuantiFERON-TB Gold In-Tube Test in Patients with Culture-Confirmed Tuberculosis: A Multicenter Retrospective Cohort Study.
abstract: BACKGROUND
  Interferon-γ release assays such as the QuantiFERON-TB Gold In-Tube Test (QFT-GIT) are designed to detect Mycobacterium tuberculosis infections, whether latent or manifesting as disease. However, a substantial number of persons with culture-confirmed tuberculosis (TB) have negative QFT-GITs. Information on host factors contributing to false-negative and indeterminate results are limited.
  
  
  METHODS
  A multicenter retrospective cohort study was performed with 1,264 culture-confirmed TB patients older than 18 years who were subjected to the QFT-GIT at one of the six hospitals between May 2007 and February 2014. Patients with human immunodeficiency virus infection were excluded. Clinical and laboratory data were collected in South Korea.
  
  
  RESULTS
  Of all patients, 87.6% (1,107/1,264) were diagnosed with pulmonary TB and 12.4% (157/1,264) with extrapulmonary TB. The rate of negative results was 14.4% (182/1,264). The following factors were highly correlated with false-negative results in the QFT-GIT: advanced age (age ≥ 65 years, odds ratio [OR] 1.57, 95% confidence interval [CI] 1.03-2.39), bilateral disease as determined by chest radiography (OR 1.75, 95% CI 1.13-2.72), malignancy (OR 2.42, 95% CI 1.30-4.49), and lymphocytopenia (total lymphocyte count < 1.0 × 109/L, OR 1.86, 95% CI 1.21-2.87).
  
  
  CONCLUSIONS
  Consequently, QFT-GIT results need to be interpreted with caution in patients with these host risk factors such as the elderly, bilateral disease on chest radiography, or malignancy, or lymphocytopenia.
authors.affiliation: Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea.
authors.forename: Yong-Soo
authors.initials: YS
authors.lastname: Kwon
authors.affiliation: Department of Pulmonary and Critical Care Medicine, Kyung Hee University Hospital at Gangdong, School of Medicine, Kyung Hee University, Seoul, Korea.
authors.forename: Yee Hyung
authors.initials: YH
authors.lastname: Kim
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Kyeongman
authors.initials: K
authors.lastname: Jeon
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Byeong-Ho
authors.initials: BH
authors.lastname: Jeong
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Department of Medicine, Ewha Medical Center and Ewha Medical Research Institute, Ewha Womans University School of Medicine, Mokdong Hospital, Seoul, Korea.
authors.forename: Yon Ju
authors.initials: YJ
authors.lastname: Ryu
authors.affiliation: Department of Internal Medicine, Chung-Ang University School of Medicine, Seoul, Korea.
authors.forename: Jae Chol
authors.initials: JC
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, College of Medicine, Gyeongsang Institute of Health Sciences, Gyeongsang National University, Jinju, Korea.
authors.forename: Ho Cheol
authors.initials: HC
authors.lastname: Kim
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Won-Jung
authors.initials: WJ
authors.lastname: Koh
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D059425:Interferon-gamma Release Tests / Q000379:methods / Q000592:standards; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012307:Risk Factors; D014376:Tuberculosis / Q000175:diagnosis* / Q000382:microbiology
chemical_list: D011933:Reagent Kits, Diagnostic