TABLE 1.
Prevalence of high-risk HPV in 4,824 self-taken samples from the CSi pilot, as detected by the Onclarity, CLART, and HC2 assays, by age, screening history, and subsequent cytology test results for HPV-positive women, compared with results for 3,347 women undergoing primary cytological screening in the Horizon study
| Characteristic | No. (%) of self-taken primary screening samples in the CSia |
No. (%) of physician-taken primary screening samples in the Horizon study |
|||||
|---|---|---|---|---|---|---|---|
| Onclarity and CLART |
HC2 |
||||||
| Total tested | HPV positive by Onclarity | HPV positive by CLART | Total tested | HPV positive | Total tested | HPV positive by CLART | |
| Age group (yr) | |||||||
| 27–29 | 383 (100.0) | 98 (25.6) | 82 (21.4) | 63 (100.0) | 15 (23.8) | 478 (100.0) | 165 (34.5) |
| 30–39 | 1,080 (100.0) | 205 (19.0) | 170 (15.7) | 201 (100.0) | 19 (9.5) | 1,295 (100.0) | 273 (21.1) |
| 40–49 | 1,200 (100.0) | 142 (11.8) | 124 (10.3) | 255 (100.0) | 22 (8.6) | 897 (100.0) | 116 (12.9) |
| 50–59 | 1,265 (100.0) | 138 (10.9) | 105 (8.3) | 279 (100.0) | 11 (3.9) | 462 (100.0) | 45 (9.7) |
| 60–65 | 896 (100.0) | 97 (10.8) | 63 (7.0) | 210 (100.0) | 6 (2.9) | 215 (100.0) | 19 (8.8) |
| Total | 4,824 (100.0) | 680 (14.1) | 544 (11.3) | 1,008 (100.0) | 73 (7.2) | 3,347 (100.0) | 618 (18.5) |
| Screening historyb for women aged ≥34 yr | |||||||
| Long-term unscreened | 1,599 (100.0) | 190 (11.9) | 147 (9.2) | 337 (100.0) | 19 (5.6) | 133 (100.0) | 20 (15.0) |
| Intermittently screened | 2,416 (100.0) | 287 (11.9) | 229 (9.5) | 525 (100.0) | 28 (5.3) | 2,158 (100.0) | 287 (13.3) |
| Total | 4,015 (100.0) | 477 (11.9) | 376 (9.4) | 815 (100.0) | 47 (5.8) | 2,291 (100.0) | 307 (13.4) |
| Physician-taken cytology samples from HPV-positive women | |||||||
| Normal | 457 (71.3) | 384 (68.8) | 318 (66.9) | 50 (73.5) | 509 (82.4) | ||
| ≥ASCUS | 182 (28.4) | 172 (30.8) | 156 (32.8) | 18 (26.5) | 109 (17.6) | ||
| Inadequate | 2 (0.3) | 2 (0.4) | 1 (0.2) | 0 (0.0) | 0 (0.0) | ||
| Total | 641 (100.0) | 558 (100.0) | 475 (100.0) | 68 (100.0) | 618 (100.0) | ||
CSi, Copenhagen Self-Sampling Initiative; HC2, Hybrid Capture 2 assay. Invalid test rates were 3.9% (n = 191) and 0.5% (n = 23) for the Onclarity and CLART assays, respectively. By definition, the HC2 assay reports no invalid test results. Three samples (0.1%) were inadequate for HPV testing by both the CLART and Onclarity assays. Because HPV results were required to be reported to women within 10 days of the arrival of the sample in the laboratory, women received their results based on the CLART and HC2 assays only for the 191 samples that were invalid by Onclarity.
Long-term unscreened, no cytology sample registered in the Patobank in ≥10 years; intermittently screened, one or more cytology samples registered within the past 10 years.