Table 2.
Test characteristics of single and double FIT sampling (OC-sensor) for colorectal cancer and advanced adenoma at a cut-off level of 50 ng/ml in asymptomatic, high-risk subjects referred for surveillance colonoscopy
| |
Single FIT(n = 1041) |
Double FIT (one FIT+)(n = 451) |
||
|---|---|---|---|---|
| CRC§ (n = 5) | Advanced adenoma‡ (n = 101) | CRC§ (n = 2) | Advanced adenoma‡ (n = 40) | |
|
Sensitivity |
80% |
28% |
50% |
33% |
| N |
4/5 |
28/101 |
1/2 |
13/40 |
| (CI in %) |
(28–99) |
(19–38) |
(1–99) |
(19–49) |
|
Specificity |
89% |
91% |
81% |
82% |
| N |
925/1036 |
852/935 |
363/449 |
336/409 |
| (CI in %) |
(87–91) |
(89–93) |
(77–84) |
(78–86) |
|
PPV* |
3% |
24% |
1% |
15% |
| N |
4/115 |
28/115 |
1/87 |
13/87 |
| (CI in %) |
(1–9) |
(17–33) |
(0,03–6) |
(8–24) |
|
NPV† |
99,9% |
92% |
99,7% |
93% |
| N |
925/926 |
853/926 |
363/364 |
337/364 |
| (CI in %) | (99–100) | (90–94) | (98–99,9) | (89–95) |
* PPV: positive predictive value.
† NPV: negative predictive value.
§ CRC: colorectal cancer.
‡ Advanced adenoma: Adenomas ≥1.0 cm, with any villous features (i.e. tubulovillous or villous adenoma) or high-grade dysplasia.