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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