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Table 3 Urine versus cervical-samples: Concordance and agreement for hrHPV positivity and analytical accuracy of urine using cervical samples as comparator test

From: Urine collection in cervical cancer screening – analytical comparison of two HPV DNA assays

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)
  1. Any hrHPV: HPV16 and/or HPV18 and/or HPV31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
  2. b HPV16/18: HPV16 and/or HPV18 including co-infections with hrHPV of other types
  3. c HrHPV other: HPV31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 including co-infections with HPV16/18
  4. 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]
  5. e Percentage of all samples that give concordant results
  6. f  Women with co-infections with HPV16/18 and hrHPV of other types appear in both sub-analyses