Table 4 Accuracy of the RISK6 signature benchmarked against the WHO target product profile for a screening/triage test.
From: RISK6, a 6-gene transcriptomic signature of TB disease risk, diagnosis and treatment response
Cohort (comparison) | RISK6 Threshold# | Sensitivity, set to ≥90% | Specificity# | Cases, n | Controls, n | AUC | AUC 95%CI | |
|---|---|---|---|---|---|---|---|---|
Cross-sectional TB (Definite TB vs asymptomatic controls) | HIV+ | 0.78 | 90.5% | 72.5% | 42 | 40 | 92.6% | 86.8–98.5% |
HIV− | 0.78 | 90.2% | 93.4% | 51 | 61 | 93.7% | 87.9–99.4% | |
ScreenTB and AE-TBC: Symptomatic adults (Definite TB vs ORD) | A-priori analysis | 0.55 | 90.8% | 55.7% | 76 | 210 | 84.8% | 79.6–90.0% |
$Post-hoc analysis in those without previous TB | 0.61 | 91.0% | 75% | 37 | 128 | 87.2% | 80.2–94.1% | |
$Post-hoc analysis in those with previous TB | 0.46 | 92.3% | 37.8% | 39 | 82 | 82.7% | 74.6–90.7% | |
RePORT-Brazil (Definite TB vs household contacts) | Definite TB vs combined QFT+ and QFT− | 0.61 | 90.2% | 73.7% | 51 | 99 | 90.9% | 85.2–96.6% |
Definite TB vs QFT+ | 0.61 | 90.2% | 59.1% | 51 | 22 | 88.6% | 81.2–96% | |
Definite TB vs QFT− | 0.61 | 90.2% | 77.9% | 51 | 77 | 91.5% | 85.9–97.1% | |
Peru (Definite TB vs household contacts) | Definite TB vs combined QFT+ and QFT− | 0.21 | 91.7% | 65.6% | 48 | 96 | 90.6% | 85.5–95.6% |
Definite TB vs QFT+ | 0.21 | 91.7% | 57.1% | 48 | 49 | 89.6% | 83.5–95.7% | |
Definite TB vs QFT− | 0.19 | 91.7% | 74.5% | 48 | 47 | 91.5% | 86.2–96.9% | |
Catalysis Cohort (Definite TB vs asymptomatic controls) | 0.39 | 90.0% | 95.2% | 87 | 21 | 93.9% | 85.5–100% | |
