TABLE 3.
Type-specific test concordance and agreement between vaginal and cervical samples
| Na | HPV typeb | +/+c | +/− | −/+ | −/− | Concordance (%) | Kappa (95% CI)d |
|---|---|---|---|---|---|---|---|
| Vaginal (Evalyn + Qvintip) and cervicale | |||||||
| Total population (N = 486) | HrHPV | 249 | 37 | 23 | 177 | 87.65 | 0.748 (0.688–0.807) |
| HPV16 | 63 | 4 | 8 | 411 | 97.53 | 0.899 (0.842–0.955) | |
| HPV18 | 16 | 5 | 2 | 463 | 98.56 | 0.813 (0.678–0.948) | |
| Other hrHPV | 196 | 40 | 25 | 225 | 86.63 | 0.732 (0.671–0.792) | |
| CIN3+ (N = 43) | HrHPV | 38 | 4 | 0 | 1 | 90.70 | 0.306 (−0.160–0.773) |
| HPV16 | 24 | 1 | 0 | 18 | 97.67 | 0.953 (0.861–1.000) | |
| HPV18 | 2 | 0 | 0 | 41 | 100 | 1.000 (1.000–1.000) | |
| Other hrHPV | 18 | 5 | 2 | 18 | 83.72 | 0.676 (0.458–0.894) | |
| CIN2+ (N = 84) | HrHPV | 72 | 6 | 0 | 6 | 92.86 | 0.632 (0.367–0.896) |
| HPV16 | 36 | 2 | 1 | 45 | 96.43 | 0. 928 (0.847–1.000) | |
| HPV18 | 3 | 0 | 0 | 81 | 100 | 1.000 (1.000–1.000) | |
| Other hrHPV | 45 | 7 | 3 | 29 | 88.10 | 0.754 (0.611–0.896) | |
| <CIN2 (N = 402) | HrHPV | 177 | 31 | 23 | 171 | 86.57 | 0.731 (0.665–0.798) |
| HPV16 | 27 | 2 | 7 | 366 | 97.76 | 0.845 (0.746–0.944) | |
| HPV18 | 13 | 5 | 2 | 382 | 98.26 | 0.779 (0.620–0.938) | |
| Other hrHPV | 151 | 33 | 22 | 196 | 86.32 | 0.723 (0.655–0.791) | |
| Evalyn Brush and cervical | |||||||
| Total population (N = 228) | HrHPV | 122 | 18 | 7 | 81 | 89.04 | 0.774 (0.691–0.857) |
| HPV16 | 38 | 2 | 1 | 187 | 98.68 | 0.954 (0.902–1.000) | |
| HPV18 | 12 | 4 | 1 | 211 | 97.81 | 0.816 (0.659–0.973) | |
| Other hrHPV | 86 | 20 | 10 | 228 | 86.84 | 0.734 (0.646–0.822) | |
| CIN3+ (N = 23) | HrHPV | 20 | 2 | 0 | 1 | 91.30 | 0.465 (−0.133–1.000) |
| HPV16 | 17 | 1 | 0 | 5 | 95.65 | 0.881 (0.654–1.000) | |
| HPV18 | 0 | 0 | 0 | 23 | NA | N/A | |
| Other hrHPV | 5 | 3 | 1 | 14 | 82.61 | 0.593 (0.242–0.944) | |
| CIN2+ (N = 47) | HrHPV | 42 | 2 | 0 | 3 | 95.74 | 0.728 (0.374–1.000) |
| HPV16 | 26 | 2 | 0 | 19 | 95.74 | 0.913 (0.796–1.000) | |
| HPV18 | 1 | 0 | 0 | 46 | 100 | 1.000 (1.000–1.000) | |
| Other hrHPV | 21 | 3 | 2 | 21 | 89.36 | 0.787 (0.611–0.963) | |
| <CIN2 (N = 181) | HrHPV | 80 | 16 | 7 | 78 | 87.29 | 0.746 (0.650–0.843) |
| HPV16 | 12 | 0 | 1 | 168 | 99.45 | 0.957 (0.873–1.000) | |
| HPV18 | 11 | 4 | 1 | 165 | 97.24 | 0.800 (0.630–0.970) | |
| Other hrHPV | 65 | 17 | 8 | 91 | 86.19 | 0.719 (0.617–0.820) | |
| Qvintip and cervical | |||||||
| Total population (N = 258) | HrHPV | 127 | 19 | 16 | 96 | 86.43 | 0.725 (0.640–0.809) |
| HPV16 | 25 | 2 | 7 | 224 | 96.51 | 0.828 (0.719–0.937) | |
| HPV18 | 4 | 1 | 1 | 252 | 99.22 | 0.796 (0.520–1.000) | |
| Other hrHPV | 110 | 20 | 15 | 113 | 86.43 | 0.729 (0.645–0.812) | |
| CIN3+ (N = 20) | HrHPV | 18 | 2 | 0 | 0 | 90.00 | NA |
| HPV16 | 7 | 0 | 0 | 13 | 100 | 1.000 (1.000–1.000) | |
| HPV18 | 2 | 0 | 0 | 18 | 100 | 1.000 (1.000–1.000) | |
| Other hrHPV | 13 | 2 | 1 | 4 | 85.00 | 0.625 (0.243–1.000) | |
| CIN2+ (N = 37) | HrHPV | 30 | 4 | 0 | 3 | 89.19 | 0.549 (0.176–0.921) |
| HPV16 | 10 | 0 | 1 | 26 | 97.30 | 0.934 (0.805–1.000) | |
| HPV18 | 2 | 0 | 0 | 35 | 100 | 1.000 (1.000–1.000) | |
| Other hrHPV | 24 | 4 | 1 | 8 | 86.49 | 0.670 (0.409–0.932) | |
| <CIN2 (N = 221) | HrHPV | 97 | 15 | 16 | 93 | 85.97 | 0.719 (0.628–0.811) |
| HPV16 | 15 | 2 | 6 | 198 | 96.38 | 0.770 (0.617–0.923) | |
| HPV18 | 2 | 1 | 1 | 217 | 99.10 | 0.662 (0.222–1.000) | |
| Other hrHPV | 86 | 16 | 14 | 105 | 86.43 | 0.727 (0.636–0.817) | |
a
N, number; CI, 95% confidence interval; CIN, cervical intraepithelial neoplasia; NA, not applicable.
b
Cutoff ≤32 cycle numbers (CN) as predefined by the manufacturer.
c
+/+ positive on vaginal and cervical samples, +/− positive only on cervical samples, −/+ positive only on vaginal samples, −/− negative on both sample types.
d
Kappa concordance between the vaginal and cervical samples was 0 to 0.2, poor; 0.21 to 0.4, fair; 0.41 to 0.6, moderate; 0.61 to 0.8, good; 0.81 to 1.0, excellent.
e
Concordance between vaginal (CN ≤35) and cervical samples (CN ≤32) is presented in Table S2A to C in Supplemental File 1.