TABLE 2.
Diagnostic test accuracy of the Onclarity hrHPV assay for detection of CIN2+ with different sample types, using the Onclarity CT cutoff value established for provider-collected samples for all sample types
| Sample type and hrHPV assay resulta | No. with histology result of: |
Sensitivity (95% CI) (%) | Specificity (95% CI) (%) | |
|---|---|---|---|---|
| CIN2+ (n = 83) | <CIN2 (n = 224) | |||
| Urine samples | ||||
| Positive | 66 | 138 | 80.0 (70.8–88.2) | 38.4 (32.0–44.8) |
| Negative | 17 | 86 | ||
| Self-collected cervicovaginal samples | ||||
| Positive | 78 | 157 | 94.0 (88.9–99.1) | 30.0 (23.9–35.9) |
| Negative | 5 | 67 | ||
| Provider-collected cervical samples | ||||
| Positive | 78 | 138 | 94.0 (88.9–99.1) | 38.4 (32.0–44.8) |
| Negative | 5 | 86 | ||
a
A CT cutoff value of ≤34.2 was used for all hrHPV subtypes except for HPV-16, for which the CT cutoff value was set at ≤38.3, according to FDA-approved thresholds for provider-collected specimens.