Table 2.
Absolute sensitivity and specificity of the OncoPredict HPV® SCR compared to GP‐EIA 5+/6+ in the total study population and women aged ≥30 years
| Parameter | Outcome | n/N a | OncoPredict HPV® SCR, % (95% CI) | n/N a | GP‐EIA 5+/6+, % (95% CI) |
|---|---|---|---|---|---|
| Total study population | |||||
| Sensitivity | CIN2+ | 90/95 | 94.7 (93.2–96.3) | 89/95 | 93.7 (92.0–95.4) |
| Sensitivity | CIN3+ | 49/50 | 98.0 (97.0–99.0) | 49/50 | 98.0 (97.0–99.0) |
| Specificity | ≤CIN1 | 659/720 | 91.5 (89.6–93.5) | 649/720 | 90.1 (88.1–92.2) |
| Women ≥ 30 years | |||||
| Sensitivity | CIN2+ | 39/42 | 92.9 (90.–94.8) | 39/42 | 92.9 (90.9–94.8) |
| Sensitivity | CIN3+ | 21/22 | 95.5 (93.8–97.1) | 21/22 | 95.5 (93.8–97.1) |
| Specificity | ≤CIN1 | 569/610 | 93.3 (91.4–95.2) | 563/610 | 92.3 (90.3–94.3) |
Note: For more details, see Supporting Information: Table 1.
Abbreviation: HPV, human papillomavirus.
a
For sensitivity, n is number of hrHPV+ among N women with disease (CIN2 + or CIN3 + ). For specificity, n is number of hrHPV‐ among N women with two consecutive negative cytology results (i.e., non‐diseased group [≤CIN1]).