Table 3. Number and percentage (95% CI) of indeterminate results, number of positive and interpretable results and sensitivity rates (percentage; 95% CI) of QuantiFERON® Gold in Tube (QFT-GIT) in groups of individuals without active TB at varying risks of M. tuberculosis exposure.
Individuals at varying risks of TB exposure | Healthy community adults | Health CareWorkers | Healthy familycontacts | Cured TBpatients | Total non- activeTB subjects | |
HIV-uninfected(N = 55) | HIV-infected(N = 54) | (N = 5) | (N = 54) | (N = 12) | (n = 180) | |
N of Indeterminate Results | 0 | 6 | 0 | 1 | 0 | 7 |
Percentage of Indeterminate Results(CI 95%) | 0.0 (0.0–6.8) | 11.1 (5.1–22.5) | 0.0 (0.0–44.4) | 1.9 (0.3–10.2) | 0.0 (0.0–25.0) | 3.9 (1.6–7.8) |
N of positive results(a)/N of interpretable results(b) | 23/55 | 19/48 | 3/5 | 33/53 | 11/12 | 89/173 |
Clinical sensitivity (%; 95% CI)(c) | 41.8 (28.7–55.9) | 35.2 (22.7–49.4) (p = 0.5563) | 60.0 (14.6–94.7) (p = 0.6439) | 61.1 (46.9–74.1) (p = 0.0559) | 91.7 (61.5–99.8) (p = 0.0028) | 49.3 (41.9–57.0) |
Laboratory sensitivity (%; 95% CI)(d) | 41.8 (29.5–55.2) | 39.6 (26.8–54.0) (p = 0.8432) | 60.0 (14.6–94.7) (p = 0.6439) | 62.3 (47.9–75.2) (p = 0.0367) | 91.7 (61.5–99.8) (p = 0.0028) | 51.5 (43.7–59.1) |
Footnotes: QFT-GIT: QuantiFERON® Gold in Tube; HIV: human immunodeficiency virus; TB: tuberculosis.
QFT-GIT with specific antigen cut –off point: 0.35 IU/mL.
QFT-GIT with PHA cut –off point: 0.50 IU/mL.
Clinical sensitivity: overall sensitivity calculated on the total of patients tested (indeterminate results included as negative).
Laboratory sensitivity: sensitivity calculated only on the interpretable results (indeterminate results excluded).