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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

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

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)
  1. a 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. 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]
  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