Skip to main content

Table 4 Rounds 1 and 2 pathology stratified by baseline Digene HC2 and Roche COBAS results

From: Comparison of the Roche cobas® 4800 and Digene Hybrid Capture® 2 HPV tests for primary cervical cancer screening in the HPV FOCAL trial

Baseline HC2/COBAS

Round 1 (Baseline + 12 months follow-up)

Round 2 (24 months)

Cytology

N

Colpo Referred/Completed

CIN2

CIN3+

Cytology

N

Colpo Referred/Completed

CIN2

CIN3+

N

Ratea (95 % CI)

N

Ratea (95 % CI)

N

Ratea (95 % CI)

N

Ratea (95 % CI)

Pos/Pos

UNSAT

1

1/1

    

UNSAT

1

0/0

    

NILM

260

152/143

22

 

16

 

NILM

208

0/0

    

ASCUS

35

35/33

6

 

2

 

ASCUS

4

3/3

    

LSIL

68

68/63

9

 

4

 

LSIL

6

6/6

    

ASCH

18

18/15

4

 

5

 

ASCH

2

2/2

    

HSIL

28

28/25

7

 

13

 

HSIL

1

1/1

    

Total

410

302/280

48

7.8 (5.6 – 10.0)

40

6.5 (4.5 – 8.5)

Total

222

13/13

0

0

Pos/Neg

UNSAT

0

0/0

    

UNSAT

1

0/0

    

NILM

81

27/23

4

   

NILM

75

0/0

    

ASCUS

10

10/9

1

   

ASCUS

2

1/1

    

LSIL

13

13/12

    

LSIL

4

4/4

    

ASCH

2

2/2

  

1

 

ASCH

0

0/0

    

HSIL

0

0/0

    

HSIL

0

0/0

    

Total

106

52/46

5b

0.8 (0.1 – 1.5)

1c

0.2 (0.0 – 0.5)

Total

82

5/5

0

0

Neg/Pos

UNSAT

3

     

UNSAT

1

0/0

    

NILM

123

     

NILM

117

0/0

    

ASCUS

1

     

ASCUS

0

0/0

    

LSIL

5

     

LSIL

2

2/2

    

ASCH

0

     

ASCH

0

0/0

    

HSIL

0

     

HSIL

1

1/1

1

   

Total

132

     

Total

121

3/3

1d

0.2 (0.0 – 0.5)

0

-

Neg/Neg

UNSAT

12

     

UNSAT

24

6/5

    

Not done

4901

            

NILM

585

     

NILM

4957

1/0

    

ASCUS

17

     

ASCUS

31

2/2

    

Other atypia

0

     

Other atypia

6

6/6

    

LSIL

8

     

LSIL

38

38/36

2

   

ASCH

1

     

ASCH

4

4/4

    

HSIL

0

     

HSIL

5

5/5

1

 

2

 

Total

5524

     

Total

5065

62/58

3e

0.6 (0.0 – 1.3)

2f

0.4 (0.0 – 0.9)

Total

 

6172

354/326

53

8.6 (6.3 – 10.9)

41

6.6 (4.6 – 8.7)

Total

5490

83/79

4

0.7 (0.0 – 1.4)

2

0.4 (0.0 – 0.9)

  1. aRate per 1,000 women screened. bBy Linear Array, two were HPV 52 positive, one HPV 56 positive, one HPV 66 positive and one HPV negative. cLinear Array was HPV negative; a LEEP one month later showed CIN2. dLinear Array was HPV 16 and HPV 51 positive at both baseline and 24 months. eBy Linear Array, two were HPV negative at baseline; at 24 months one was HPV 66 positive and the second was HPV 35 and HPV 58 positive. The third case was HPV 66 positive at baseline and HPV 16, HPV 18 and HPV 66 positive at 24 months. fBy Linear Array, one was HPV 16 and HPV 52 positive at baseline and HPV 52 positive at 24 months; the second was HPV 16 positive at both baseline and 24 months
  2. Abbreviations: HC2 Digene Hybrid Capture® 2 high-risk HPV DNA test®, COBAS Roche cobas® 4800 HPV test, UNSAT smear unsatisfactory; NILM negative for intraepithelial lesions and malignancy, ASCUS atypical squamous cells undetermined significance, ASCH atypical squamous cells, cannot rule out high-grade, LSIL low-grade squamous intraepithelial lesion, HSIL high-grade squamous intraepithelial lesion, CIN cervical intraepithelial neoplasia, LEEP loop electrosurgical excision procedure