Table 1. Sensitivity and specificity of FIT, CORD assay, and the combination of FIT and CORD assay for the findings of colonoscopy.
| Most advanced findings | Colonoscopy (N = 138) | FIT (N = 138) | Serum CORD assay of TWIST1 (N = 138) | Combination (N = 138) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Positive results | Specificity | P value | OR (95% CI) | Positive resultsa | Specificity | P value | OR (95% CI) | Positive resultsb | Specificity | P value | OR (95% CI) | ||
| No. | No. | % | No. | % | No. | % | |||||||
| Negative results on colonoscopy | 25 | 3 | 88.0 | 1.000 (Reference) |
2 | 92.0 | 1.000 (Reference) |
4 | 84.0 | 1.000 (Reference) |
|||
|
Sensitivity (95% CI) |
Sensitivity (95% CI) |
Sensitivity (95% CI) |
|||||||||||
| Non-advanced adenoma | 25 | 2 | 8.0 (1.0–26.0) |
1.0000 | 0.6377 (0.09704–4.190) |
9 | 36.0 (18.0–57.5) |
0.0374 | 6.469 (1.230–34.026) |
10 | 40.0 (22.1–61.3) |
0.1137 | 3.500 (0.9203–13.311) |
| Advanced adenoma | 70 | 17 | 24.3 (14.8–36.1) |
0.2594 | 2.352 (0.6255–8.845) |
21 | 30.0 (19.6–42.1) |
0.0306 | 4.929 (1.064–22.830) |
32 | 45.7 (33.7–58.1) |
0.0089 | 4.421 (1.374–14.221) |
| Colorectal cancer (stage I) |
14 | 4 | 28.6 (8.4–58.1) |
0.2251 | 2.933 (0.5502–15.639) |
7 | 50.0 (23.0–77.0) |
0.0052 | 11.500 (1.929–68.548) |
9 | 64.3 (35.1–87.2) |
0.0041 | 9.450 (2.047–43.263) |
| Colorectal cancer (all stages) |
18 | 8 | 44.4 (21.5–69.3) |
0.0312 | 5.867 (1.279–26.914) |
8 | 44.4 (21.5–69.3) |
0.0092 | 9.200 (1.650–51.305) |
13 | 72.2 (46.6–90.3) |
0.0004 | 13.650 (3.089–60.324) |
95% CI: 95% confidence interval; CORD: combined restriction digital PCR; FIT: fecal immunochemical test for hemoglobin; OR: odds ratio.
aCriterion for a positive result of the CORD assay is the presence of 2.8 or more copy numbers of methylated TWIST1.
bCriterion for a positive result with the combination of FIT and CORD assay is either a positive FIT or CORD assay or both are positive.