Table 3.
Urine versus cervical-samples: Concordance and agreement for hrHPV positivity and analytical accuracy of urine using cervical samples as comparator test
| hrHPV result | Assay (total) |
Cervical positive |
Cervical negative |
Kappad (95%CI) |
Agreemente (%)(95%CI) |
Sensitivity (%)(95%CI) |
Specificity (%)(95%CI) |
|
|---|---|---|---|---|---|---|---|---|
| Any hrHPVa (14 types) |
Cobas (n = 150) |
Urine positive | 23 | 4 | ||||
| Urine negative | 13 | 110 | 0.66 (0.51–0.81) | 88.7 (82.5–93.3) | 63.9 (46.2–79.2) | 96.5 (91.3–99.0) | ||
|
Clart (n = 150) |
Urine positive | 16 | 9 | |||||
| Urine negative | 15 | 110 | 0.47 (0.30–0.65) | 84.0 (77.1–89.5) | 51.6 (33.0–69.8) | 92.4 (86.1–96.5) | ||
| HPV16/18b,f |
Cobas (n = 150) |
Urine positive | 4 | 2 | ||||
| Urine negative | 11 | 133 | 0.34 (0.08–0.61) | 91.3 (85.6–95.3) | 26.7 (0.07–55.1) | 98.5 (94.8–99.8) | ||
|
Clart (n = 150) |
Urine positive | 4 | 0 | |||||
| Urine negative | 4 | 142 | 0.65 (0.34–0.97) | 97.3 (93.3–99.3) | 50.0 (15.7–84.3) | 100.0 (97.4–100.0) | ||
| hrHPV otherc,f (12 types) |
Cobas (n = 150) |
Urine positive | 20 | 4 | ||||
| Urine negative | 9 | 117 | 0.70 (0.55–0.85) | 91.3 (85.6–95.3) | 69.0 (49.2–84.7) | 96.7 (91.8–99.1) | ||
|
Clart (n = 150) |
Urine positive | 12 | 9 | |||||
| Urine negative | 17 | 112 | 0.38 (0.19–0.57) | 82.7 (75.6–88.4) | 41.4 (23.5–61.1) | 92.6 (86.3–96.5) |
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