Table 2. Number and percentage (95% CI) of indeterminate results, number of positive and interpretable results and positive sensitivity rates (percentage; 95% CI) of QuantiFERON® Gold in Tube (QFT-GIT) in pulmonary TB patients stratified by HIV status and disease localization.
Active Pulmonary TB patients | HIV-infected | HIV-uninfected | Total patientstested | p value; HIV-infected vs HIV-uninfected |
(N = 38) | (N = 58) | (N = 96) | ||
N of indeterminate results | 9 | 2 | 11 | |
Percentage of indeterminate results (95% CI) | 23.7 (11.4–40.2) | 3.5 (0.9–11.9) | 11.5 (5.9–19.6 | 0.006 |
N of positive results(a)/N of interpretable results(b) | 26/29 | 53/56 | 79/85 | |
Clinical sensitivity(c) (%; 95% CI) | 68.4 (51.4–82.5) | 91.4 (81.1–96.3) | 82.5 (73.2–89.3 | 0.0053 |
Laboratory sensitivity(d) (%, 95% CI) | 89.7 (72.2–97.8) | 94.6 (85.1–98.2) | 92.9 (83.8–96.6 | 0.4058 |
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).