TABLE 1.
Characteristics of the study population of the VALGENT4 panel and prevalence of hrHPV as assessed by the Onclarity assay and the GP-EIA
| Characteristica | Total | No. (%) hrHPV positive by the: |
|
|---|---|---|---|
| Onclarity assay | GP-EIA | ||
| Group | |||
| All | 1,295 | 368 (28.4) | 396 (30.6) |
| Screening | 998 | 113 (11.3) | 143 (14.3) |
| Enriched | 297 | 255 (85.9) | 253 (85.2) |
| Age (yr) | |||
| 30–39 | 531 | 192 (36.2) | 202 (38.0) |
| 40–49 | 519 | 126 (24.3) | 136 (26.2) |
| 50–59 | 245 | 50 (20.4) | 58 (23.7) |
| Cytology | |||
| Normal | 947 | 73 (7.7) | 105 (11.1) |
| ASCUS | 106 | 103 (97.2) | 97 (91.5) |
| LSIL | 121 | 88 (72.7) | 88 (72.7) |
| HSIL | 106 | 93 (87.7) | 96 (90.6) |
| AGC/ASC-H/AIS | 15 | 1 (73.3) | 0 (66.7) |
| Finding upon histological follow-up | |||
| No follow-up | 946 | 106 (11.2) | 139 (14.7) |
| CIN0 | 154 | 82 (53.2) | 78 (50.6) |
| CIN1 | 73 | 67 (91.8) | 66 (90.4) |
| CIN2 | 39 | 33 (84.6) | 35 (89.7) |
| CIN3 | 75 | 72 (96.0) | 70 (93.3) |
| Cancer | 8 | 8 (100) | 8 (100) |
| ≥CIN2 | 122 | 113 (92.6) | 113 (92.6) |
| 2×NILM | 897 | 66 (7.4) | 97 (10.8) |
a
ASCUS, atypical squamous cells of undetermined significance; LSIL, low-grade squamous intraepithelial lesions; HSIL, high-grade squamous intraepithelial lesions; AGC, atypical glandular cells; ASC-H, atypical squamous cells for which HSIL cannot be excluded; AIS, adenocarcinoma in situ; CIN, cervical intraepithelial neoplasia; ≥CIN2, CIN of grade 2 or worse; NILM, negative for intraepithelial lesions or malignancies; 2×NILM, NILM at both the prior screening round and the index screening.