Table 1.
Characteristics of the Study Population and Human Papillomavirus Prevalence by Onclarity-COR, Onclarity-Viper, and GP-EIA
| Onclarity-COR | Onclarity-Viper | GP-EIA Assay | ||
|---|---|---|---|---|
| Total | hrHPV-Positive, No. (%) | hrHPV-Positive, No. (%) | hrHPV-Positive, No. (%) | |
| All | 1,295 | 369 (28.3) | 369 (28.4) | 396 (30.6 ) |
| Age, y | ||||
| 30-39 | 531 | 194 (36.5) | 193 (36.3) | 202 (38.0) |
| 40-49 | 519 | 124 (23.9) | 130 (25.0) | 136 (26.2) |
| 50-59 | 245 | 51 (20.8) | 51 (20.8) | 58 (23.7) |
| Cytology | ||||
| Normal | 947 | 75 (7.9) | 78 (8.2) | 105 (11.1) |
| ASCUS | 106 | 100 (94.3) | 103 (97.2) | 97 (91.5) |
| LSIL | 121 | 88 (72.7) | 88 (72.7) | 88 (72.7) |
| HSIL | 106 | 95 (89.6) | 94 (88.7) | 96 (90.6) |
| AGC/ASCH/AIS | 15 | 11 (73.3) | 11 (73.3) | 10 (66.7) |
| Histologic follow-up | ||||
| No biopsy | 946 | 108 (11.4) | 111 (11.7) | 139 (14.7) |
| NILM | 154 | 80 (51.9) | 82 (53.2) | 78 (50.6) |
| CIN1 | 73 | 66 (90.4) | 67 (91.8) | 66 (90.4) |
| CIN2 | 39 | 35 (89.7) | 34 (87.2) | 35 (89.7) |
| CIN3 | 75 | 72 (96.0) | 72 (96.0) | 70 (93.3) |
| Carcinoma | 8 | 8 (100) | 8 (100) | 8 (100) |
| ≥CIN2 | 122 | 115 (94.3) | 114 (93.4) | 113 (92.6) |
| ≥CIN3 | 83 | 80 (96.4) | 80 (96.4) | 78 (94.0) |
| 2×NILM1 | 887 | 66 (7.4) | 70 (7.9) | 95 (10.7) |
2×NILM, NILM at baseline and 12-24 months prior; AGC, atypical glandular cell; AIS, adenocarcinoma in situ; ASCH, atypical cells—cannot exclude HSIL; ASCUS, abnormal squamous cells of undetermined significance; CIN, cervical intraepithelial neoplasia; GP-EIA, glycoprotein 5–positive/6–positive enzyme immunoassay; hrHPV, high-risk human papillomavirus; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion; NILM, negative for intraepithelial lesions or malignancy; Onclarity-COR, Onclarity HPV Assay on the COR instrument; Onclarity-Viper, Onclarity HPV Assay on the Viper LT instrument.