Table 4.
CLART results for 4,410 primary a samples, by age, screening history, cytology, and HC2 results
| Outcomes on CLART, N (%) | |||||
|---|---|---|---|---|---|
| Any high-risk genotype (%)b | No high-risk genotypes (%)c | Only low-risk genotypes (%)b | Invalid (%) | Total (%) | |
| Total | 1,024 (23.2%) | 3,375 (76.5%) | 528 (12.0%) | 11 (0.2%) | 4,410 (100%) |
| Age (years) | |||||
| 16-22 | 77 (57.0%) | 58 (43.0%) | 18 (13.3%) | 0 (0.0%) | 135 (100%) |
| 23-29 | 485 (37.7%) | 801 (62.2%) | 175 (13.6%) | 1 (0.1%) | 1,287 (100%) |
| 30-39 | 274 (21.1%) | 1,021 (78.6%) | 139 (10.7%) | 4 (0.3%) | 1,299 (100%) |
| 40-49 | 116 (12.8%) | 783 (86.6%) | 104 (11.5%) | 5 (0.6%) | 904 (100%) |
| 50-59 | 45 (9.7%) | 419 (90.1%) | 55 (11.8%) | 1 (0.2%) | 465 (100%) |
| 60-65 | 19 (8.8%) | 196 (91.2%) | 22 (10.2%) | 0 (0.0%) | 215 (100%) |
| >65 | 8 (7.6%) | 97 (92.4%) | 15 (14.3%) | 0 (0.0%) | 105 (100%) |
| Cytology | |||||
| Normal | 847 (20.4%) | 3,290 (79.3%) | 494 (11.9%) | 11 (0.3%) | 4,148 (100%) |
| ASCUS | 49 (57.6%) | 36 (42.4%) | 9 (10.6%) | 0 (0.0%) | 85 (100%) |
| LSIL | 64 (73.6%) | 23 (26.4%) | 20 (23.0%) | 0 (0.0%) | 87 (100%) |
| ≥HSIL | 64 (92.8%) | 5 (7.2%) | 2 (2.9%) | 0 (0.0%) | 69 (100%) |
| ≥ASCUS | 177 (73.4%) | 64 (26.6%) | 31 (12.9%) | 0 (0.0%) | 241 (100%) |
| Inadequate | 0 (0.0%) | 21 (100%) | 3 (14.3%) | 0 (0.0%) | 21 (100%) |
| HC2 d | |||||
| Positive | 693 (84.3%) | 128 (15.6%) | 84 (10.2%) | 1 (0.1%) | 822 (100%) |
| Negative | 330 (9.2%) | 3,245 (90.5%) | 444 (12.4%) | 10 (0.3%) | 3,585 (100%) |
Abbreviations: ASCUS atypical squamous cells of undetermined significance, HC2 Hybrid Capture 2 assay, HPV Human Papillomavirus, ≥HSIL high-grade intraepithelial lesions or worse, LSIL low-grade squamous intraepithelial lesions.
aPredominantly screening samples, including a small proportion of samples taken for indication.
bAccording to classification reported by IARC [2].
cConsidered negative on the CLART assay.
dThree samples were not tested with HC2.