Table 1
Number of HPV test results according to “grey zones” proposed by the manufacturer (PreservCyt)I, Seme et al. (STM)II, and the Department of Cytopathology at Institute of Oncology Ljubljana (STM)Ill
| RLU/CO value I | N and % women (Ntot = 594) |
|---|---|
| < 1.0 | 283 (47.6) |
| 1.0–2.5 | 23 (3.9) |
| > 2.5 | 288 (48.5) |
| RLU/CO value II | N and % women (Tot. N = 594) |
|---|---|
| < 0.4 | 253 (42.6) |
| 0.4–0.99 | 30 (5.1) |
| 1.0–3.99 | 34 (5.7) |
| ≥ 4.0 | 277 (46.6) |
| RLU/CO value Ill | N and % women (Tot. N = 594) |
|---|---|
| < 0.7 | 271 (45.6) |
| 0.7–0.99 | 12 (2.0) |
| 1.0–1.99 | 15 (2.5) |
| ≥ 2.0 | 296 (49.8) |
[i] N = number; Ntot = total number
Figure 1
Changes in the RLU/CO values after retesting samples within the 0.4–4.0 RLU/CO range. The red arrow represents the samples with changes in the results from negative to positive, the blue arrows represent samples with changes in the results from positive to negative, and the black arrows represent samples that retained the original result.
Table 2
The distribution of women with a CIN2+/3+ diagnosis and the risk for CIN2+/3+ based on the RLU/CO values of their HPV test results
| RLU/CO value | N and % women (Ntot = 594) | N and % CIN2+ (Ntot = 162) | Risk for CIN2+ (%) | N and % CIN3+ (Ntot = 114) | Risk for CIN3+ (%) |
|---|---|---|---|---|---|
| RLU/CO < 0.4 | 253 (42.6) | 8 (4.9) | 3.2 | 2 (1.8) | 0.8 |
| 0.4 ≤ RLU/CO < 0.7 | 18 (3.0) | 1 (0.6) | 5.6 | 1 (0.9) | 5.6 |
| 0.7 ≤ RLU/CO < 1.0 | 12 (2.0) | 1 (0.6) | 8.3 | 1 (0.9) | 8.3 |
| 1.0 ≤ RLU/CO ≤ 2.0 | 15 (2.5) | 1 (0.6) | 6.7 | 1 (0.9) | 6.7 |
| 2.0 < RLU/CO ≤ 2.5 | 8 (1.3) | 3 (1.9) | 37.5 | 2 (1.8) | 25.0 |
| 2.5 < RLU/CO ≤ 4.0 | 11 (1.9) | 3 (1.9) | 27.3 | 2 (1.8) | 18.2 |
| 4.0 < RLU/CO ≤ 10.0 | 26 (4.4) | 7 (4.3) | 26.9 | 6 (5.3) | 23.1 |
| 10.0 < RLU/CO ≤ 100 | 112 (18.9) | 48 (29.6) | 42.9 | 33 (28.9) | 29.5 |
| 100 < RLU/CO ≤ 1000 | 105 (17.7) | 68 (42.0) | 64.8 | 53 (46.5) | 50.5 |
| 1000 < RLU/CO | 34 (5.7) | 22 (13.6) | 64.7 | 13 (11.4) | 38.2 |
[i] CIN2+ = cervical intraepithelial neoplasia grade 2 or greater; CIN3+ = cervical intraepithelial neoplasia grade 3 or greater; N = number; Ntot = total number
Figure 2
ROC curve demonstrating the sensitivity and specificity of the HC2 test for CIN2+ with marked RLU/CO cutoff values that represent the lower and upper borders of the “grey zone” ranges.