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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