TABLE 2.
Clinical performance of the Xpert HPV compared to a standard, clinically validated comparator test (GP5+/6+ EIA or hc2)
| Age group | Measure | Outcome (No.) | Absolute accuracy (% [95% CI]) |
Relative accuracy: Xpert HPV vs SCT (95% CI) | PMcN | Pn.inf | |
|---|---|---|---|---|---|---|---|
| Xpert HPV | SCT | ||||||
| VALGENT 2 | |||||||
| All ages | Sensitivity | CIN2+ (101) | 94.1 (87.5–97.8) | 94.1 (87.5–97.8) | 1.000 (0.960, 1.042) | 1.00 | 0.0017 |
| Sensitivity | CIN3+ (55) | 98.2 (90.3–100) | 98.2 (90.3–100) | 1.000 | 1.00 | 0.0072 | |
| Specificity | ≤CIN1 (842) | 82.7 (79.9–85.1) | 83.2 (80.6–85.7) | 0.993 (0.972–1.014) | 0.50 | <0.0001 | |
| ≥30 yr | Sensitivity | CIN2+ (41) | 90.2 (76.9–97.3) | 92.7 (80.1–98.5) | 0.974 (0.889–1.066) | 1.00 | 0.0951 |
| Sensitivity | CIN3+ (24) | 95.8 (78.9–99.9) | 95.8 (78.9–99.9) | 1.000 | 1.00 | 0.055 | |
| Specificity | ≤CIN1 (652) | 88.3 (85.6–90.7) | 89.4 (86.8–91.7) | 0.988 (0.968–1.008) | 0.24 | <0.0001 | |
| Aggregated set | |||||||
| All ages | Sensitivity | CIN2+ (180) | 96.1 (92.2–984) | 96.1 (92.2–98.4) | 1.000 (0.978–1.023) | 1.00 | <0.0001 |
| Sensitivity | CIN3+ (102) | 99.0 (94.7–100) | 99.0 (94.7–100) | 1.000 | 1.00 | 0.0004 | |
| Specificity | ≤CIN1 (4,171) | 82.5 (81.3–83.6) | 82.1 (80.9–83.3) | 1.001 (0.992–1.011) | 0.76 | <0.0001 | |
| ≥30 yr | Sensitivity | CIN2+ (68) | 92.6 (837–97.6) | 94.1 (85.6–98.4) | 0.984 (0.931–1.040) | 1.00 | 0.019 |
| Sensitivity | CIN3+ (38) | 97.4 (86.2–99.9) | 97.4 (86.2–99.9) | 1.000 | 1.00 | 0.021 | |
| Specificity | ≤CIN1 (3,206) | 88.1 (86.9–89.2) | 87.5 (86.3–88.6) | 1.006 (0.997–1.016) | 0.18 | <0.0001 | |
a Absolute sensitivities of the tests for CIN2+ or CIN3+ and specificity for ≤CIN1 are presented, as is the relative accuracy of the Xpert HPV compared to the comparator tests. The statistical tests in the last two columns verify differences (P for the McNemar test [PMcN] or noninferiority [Pn.inf]). The upper six rows show accuracy measures according to the VALGENT-2 set where the comparator test was GP5+/6+ EIA. The aggregated data set incorporates VALGENT-2 and data from Cuzick et al. (7) where the comparator test was hc2.