Table 2.
Neoplasm Detection Rates by a Next-Generation Stool DNA Testa
| Sensitivity, % (95% CI) | Observed specificity, % (95% CI) | |
|---|---|---|
| Training set | ||
| Cancer | 89 (83–93) | 90 (85–94) |
| Adenoma | ||
| Size >1 cm | 62 (49–74) | 90 (85–94) |
| Size ≥1 cm | 56 (45–67) | 90 (85–94) |
| Test set | ||
| Cancer | 78 (68–86) | 85 (77–92) |
| Adenoma | ||
| Size >1 cm | 64 (45–80) | 85 (77–92) |
| Size ≥1 cm | 48 (31–66) | 85 (77–92) |
| Combined | ||
| Cancer | 85 (80–89) | 89 (85–92) |
| Adenoma | ||
| Size >1 cm | 63 (52–73) | 89 (85–92) |
| Size ≥1 cm | 53 (45–62) | 89 (85–92) |
CI, confidence interval.
a
Stool DNA test marker panel: methylated vimentin, NDRG4, BMP3, and TFPI2; mutant KRAS; a reference gene β-actin; and hemoglobin quantity. Using a logistical regression model, a 90% specificity cut-off was determined in the training set by selecting the 90th percentile from control patients with normal colonoscopy; this cut-off was applied to the test set.