Table 3.
Prognostic performance of RISK11 and the interferon-γ release assay for incident tuberculosis over 15 months
| RISK11 (60)* | Interferon-γ release assay | |
|---|---|---|
| Primary endpoint (two or more positive samples) | ||
| Participants included in analysis | 807 | 802† |
| Cumulative incidence ratio (95% CI; p value) | 16·0 (2·0–129·5; p=0·0092) | 2·0 (0·5–8·4;p=0·33) |
| AUC | 80·0% (70·6–86·9) | 70·8% (55·0–82·7) |
| Sensitivity | 88·6% (43·5–98·7) | 62·1% (25·9–88·5) |
| Specificity | 68·9% (65·3–72·3) | 56·2% (52·5–59·9) |
| Positive predictive value‡ | 3·2% (1·5–6·6) | 1·6% (0·7–3·8) |
| Negative predictive value‡ | 99·8% (98·6–100·0) | 99·2% (97·6–99·8) |
| Secondary endpoint (one or more positive samples) | ||
| Participants included in analysis | 799 | 794† |
| Cumulative incidence ratio (95% CI; p value) | 6·1 (2·2–16·5; p=0·0004) | 2·2 (0·9–5·6; p=0·081) |
| AUC | 74·8% (64·2–83·1) | 66·0% (53·8–76·4) |
| Sensitivity | 74·9% (51·3–89·4) | 64·8% (42·1–82·4) |
| Specificity | 69·0% (65·5–72·4) | 56·5% (52·7–60·2) |
| Positive predictive value‡ | 6·5% (4·0–10·6) | 4·2% (2·4–7·0) |
| Negative predictive value‡ | 99·0% (97·5–99·6) | 98·2% (96·3–99·2) |
Data are % (95% CI), unless otherwise specified. Performance of RISK11 and the interferon-γ release assay for incident secondary endpoint tuberculosis during 12 months of follow-up can be found in the appendix (p 11). AUC=area under the receiver operating characteristic curve.
*
A priori (60%) RISK11 score threshold.
†
Five participants without results from the interferon-γ release assay, all tuberculosis-negative, were excluded from the prognostic performance analysis.
‡
Computed by use of incidence in the study population.