Table 2.
Urine versus vaginal self-samples: Concordance and agreement for hrHPV positivity and analytical accuracy of urine using vaginal self-samples as comparator test
| hrHPV result | Assay (total) |
Vaginal positive |
Vaginal negative |
Kappad (95%CI) |
Agreemente (%)(95%CI) |
Sensitivity (%)(95%CI) |
Specificity (%)(95%CI) |
|
|---|---|---|---|---|---|---|---|---|
| Any hrHPVa (14 types) |
Cobas (n = 150) |
Urine positive | 26 | 1 | ||||
| Urine negative | 18 | 105 | 0.66 (0.52–0.79) | 87.3 (80.9–92.2) | 59.1 (43.2–73.7) | 99.1 (94.9–99.7) | ||
|
Clart (n = 150) |
Urine positive | 20 | 5 | |||||
| Urine negative | 15 | 110 | 0.59 (0.43–0.75) | 86.7 (80.2–91.7) | 57.1 (39.4–73.7) | 95.7 (90.1–98.6) | ||
| HPV16/18b,f |
Cobas (n = 150) |
Urine positive | 6 | 0 | ||||
| Urine negative | 11 | 133 | 0.49 (0.23–0.74) | 92.7 (87.3–96.3) | 35.3 (14.2–61.7) | 100.0 (97.3–100.0) | ||
|
Clart (n = 150) |
Urine positive | 4 | 0 | |||||
| Urine negative | 5 | 141 | 0.60 (0.29–0.92) | 96.7 (92.4–98.9) | 44.4 (13.7–78.8) | 100 (97.4–100.0) | ||
| hrHPV otherc,f (12 types) |
Cobas (n = 150) |
Urine positive | 23 | 1 | ||||
| Urine negative | 15 | 111 | 0.68 (0.54–0.82) | 89.3 (83.3–93.8) | 60.5 (43.4–75.9) | 99.1 (95.1–99.9) | ||
|
Clart (n = 150) |
Urine positive | 16 | 5 | |||||
| Urine negative | 15 | 114 | 0.54 (0.36–0.71) | 86.7 (80.2–91.7) | 51.6 (33.1–69.8) | 95.8 (90.5–98.6) |
a Any hrHPV: HPV16 and/or HPV18 and/or HPV31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
b HPV16/18: HPV16 and/or HPV18 including co-infections with hrHPV of other types
c HrHPV other: HPV31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 including co-infections with HPV16/18
d Cohens Kappa. “Poor” (κ ≤ 0.20), “fair” (0.21 ≤ κ ≤ 0.40), “moderate” (0.41 ≤ κ ≤ 0.60), “good” (0.61 ≤ κ ≤ 0.80), or “very good” (κ ≥ 0.81) [25]
e Percentage of all samples that give concordant results
f Women with co-infections with HPV16/18 and hrHPV of other types appear in both sub-analyses