TABLE 2.
Relative sensitivity and specificity of the RealTime High Risk HPV assay on vaginal self-samples versus cervical clinician-collected samples
| CN cutoff | CIN2+ sensitivity (95% CI)a | CIN3+ sensitivity (95% CI) | <CIN2 specificity (95% CI) |
|---|---|---|---|
| Women ≥30 yrs old (N = 390), CN ≤ 32b | |||
| Vaginal (E + Q) | 0.91 (0.84–0.99) | 0.91 (0.81–1.01) | 1.05 (0.97–1.14) |
| Evalyn | 0.97 (0.90–1.03) | 0.94 (0.83–1.06) | 1.11 (0.996–1.23) |
| Qvintip | 0.85 (0.72–0.997) | 0.88 (0.73–1.05) | 1.00 (0.89–1.12) |
| Total study population (N = 486), CN ≤ 32b | |||
| Vaginal (E + Q) | 0.92 (0.87–0.98) | 0.90 (0.82–0.998) | 1.04 (0.97–1.12) |
| Evalyn | 0.95 (0.89–1.02) | 0.91 (0.80–1.04) | 1.11 (1.00–1.30) |
| Qvintip | 0.88 (0.78–0.998) | 0.90 (0.78–1.04) | 0.99 (0.90–1.10) |
| Women ≥ 30 yrs old (N = 390), CN ≤ 35c | |||
| Vaginal (E + Q) | 0.95 (0.87–1.03) | 0.91 (0.81–1.01) | 0.95 (0.87–1.03) |
| Evalyn | 0.97 (0.90–1.03) | 0.94 (0.83–1.06) | 1.03 (0.93–1.14) |
| Qvintip | 0.92 (0.79–1.08) | 0.88 (0.73–1.05) | 0.88 (0.77–0.99) |
| Total study population (N = 486), CN ≤ 35c | |||
| Vaginal (E + Q) | 0.91 (0.84–0.99) | 0.91 (0.81–1.01) | 1.05 (0.97–1.14) |
| Evalyn | 0.97 (0.90–1.03) | 0.94 (0.83–1.06) | 1.11 (0.996–1.23) |
| Qvintip | 0.85 (0.72–0.997) | 0.88 (0.73–1.05) | 1.00 (0.89–1.12) |
a
CI, 95% confidence interval; CIN, cervical intraepithelial neoplasia; E+Q, samples collected with Evalyn Brush (E) and Qvintip (Q) combined; N, number.
b
Cutoff ≤ 32 cycle numbers (CN) as predefined by the manufacturer.
c
Exploratory cutoff ≤35 CNs for vaginal samples.