Table 3.
Sensitivities and specificities of the in vitro diagnostic test
| Sensitivity (%) [95%CI] | Sensitivity [95% CI] | Specificity (%) [95%CI] | Specificity [95%CI] | |||||
|---|---|---|---|---|---|---|---|---|
| Stagea | N | ApoA2-ATQ/AT (< 59.5 μg/mLb) |
CA19-9 (> 37 U/mLb) |
ApoA2-ATQ/AT (< 59.5 μg/mLb) CA19-9 (> 37 U/mLb) |
ApoA2-ATQ/AT (< 59.5 μg/mLb) |
CA19-9 (> 37 U/mLb) |
ApoA2-ATQ/AT (< 59.5 μg/mLb) CA19-9 (> 37 U/mLb) |
|
| PDAC | All | 106 | 63.2 [53.7, 71.8] | 69.8 [60.5, 77.7] | 87.7*** [80.1, 92.7] | – | – | – |
| I | 19 | 47.4 [27.3, 68.3] | 36.8 [19.1, 59.0] | 63.2* [41.0, 80.9] | – | – | – | |
| IA | 8 | 37.5 [13.7, 69.4] | 37.5 [13.7, 69.4] | 62.5 [30.6, 86.3] | – | – | – | |
| IB | 11 | 54.5 [28.0, 78.7] | 36.4 [15.2, 64.6] | 63.6 [35.4, 84.8] | – | – | – | |
| IIB | 11 | 54.5 [28.0, 78.7] | 63.6 [35.4, 84.8] | 81.8 [52.3, 94.9] | – | – | – | |
| III | 22 | 72.7 [51.8, 86.8] | 77.3 [56.6, 89.9] | 90.9 [72.2, 97.5] | – | – | – | |
| IV | 54 | 66.7 [53.4, 77.8] | 79.6 [67.1, 88.2] | 96.3** [87.5, 99.0] | – | – | – | |
| I, II | 30 | 50.0 [33.2, 66.8] | 46.7 [30.2, 63.9] | 70.0** [52.1, 83.3] | – | – | – | |
| TS1 | 15 | 46.7 [24.8, 69.9] | 33.3 [15.2, 58.3] | 66.7* [41.7, 84.8] | – | – | – | |
| Healthy individuals | 106 | – | – | – | 95.3 [89.4, 98.0] | 95.3 [89.4, 98.0] | 91.5 [84.6, 95.5] | |
CI confidence interval, PDAC pancreatic ductal adenocarcinoma, TS1 tumor size ≤ 2.0 cm
aStage: Union for International Cancer Control (UICC) classification 8th edition
bCutoff value, significance of differences in sensitivity between combination of apoA2-ATQ/AT with CA19-9 and CA19-9 alone: *p < 0.05, **p < 0.01, and ***p < 0.001 (McNemar test)