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Table 1 Description of the 401 women included in the study

From: Comparison of analytical and clinical performance of CLART HPV2 genotyping assay to Linear Array and Hybrid Capture 2: a split-sample study

 

Total

CLART

LA

HC2

P

  

High-risk genotypes

Low-risk genotypes

No HPV genotypesc

High-risk genotypes

Low-risk genotypes

No HPV genotypesc

Positive test result

Negative test result

CLART vs. LA

CLART vs. HC2

Total

401 (100%)

311 (78%)

54 (13%)

36 (9%)

326 (81%)

54 (13%)

21 (5%)

355 (89%)

46 (11%)

  

Age (years)

           

<30

215 (100%)

180 (84%)

21 (10%)

14 (7%)

184 (86%)

21 (10%)

10 (5%)

192 (89%)

23 (11%)

0.701

0.090

30-39

96 (100%)

74 (77%)

16 (17%)

6 (6%)

80 (83%)

13 (14%)

3 (3%)

86 (90%)

10 (10%)

0.462

0.020

≥40

90 (100%)

57 (63%)

17 (19%)

16 (18%)

62 (69%)

20 (22%)

8 (9%)

77 (86%)

13 (14%)

0.210

0.001

P

 

0.001

0.012

0.602

  

Cytology

           

ASCUS

103 (100%)

78 (76%)

11 (11%)

14 (14%)

82 (80%)

10 (10%)

11 (11%)

88 (85%)

15 (15%)

0.776

0.078

LSIL

161 (100%)

113 (70%)

37 (23%)

11 (7%)

119 (74%)

38 (24%)

4 (2%)

140 (87%)

21 (13%)

0.180

<0.001

≥HSILa

137 (100%)

120 (88%)

6 (4%)

11 (8%)

125 (91%)

6 (4%)

6 (4%)

127 (93%)

10 (7%)

0.455

0.156

P

 

<0.001

<0.001

0.156

  

Worst follow-up outcome

           

No follow-up

17 (100%)

14 (82%)

2 (12%)

1 (6%)

14 (82%)

3 (18%)

0 (0%)

16 (94%)

1 (6%)

0.549

0.287

Normal cytology or negative HPV test

75 (100%)

56 (75%)

8 (11%)

11 (15%)

60 (80%)

6 (8%)

9 (12%)

60 (80%)

15 (20%)

0.732

0.435

Abnormal cytology or positive HPV test

10 (100%)

7 (70%)

2 (20%)

1 (10%)

8 (80%)

2 (20%)

0 (0%)

8 (80%)

2 (20%)

0.587

0.605

Inadequate histology

9 (100%)

3 (33%)

3 (33%)

3 (33%)

3 (33%)

3 (33%)

3 (33%)

6 (67%)

3 (33%)

1.000

0.157

CIN0

98 (100%)

57 (58%)

29 (30%)

12 (12%)

61 (62%)

31 (32%)

6 (6%)

77 (79%)

21 (21%)

0.333

0.002

CIN1b

67 (100%)

58 (87%)

5 (7%)

4 (6%)

60 (90%)

5 (7%)

2 (3%)

65 (97%)

2 (3%)

0.704

0.028

CIN2

35 (100%)

32 (91%)

2 (6%)

1 (3%)

33 (94%)

2 (6%)

0 (0%)

34 (97%)

1 (3%)

0.602

0.303

CIN3

86 (100%)

81 (94%)

3 (3%)

2 (2%)

83 (97%)

2 (2%)

1 (1%)

85 (99%)

1 (1%)

0.757

0.096

Cervical cancer

4 (100%)

3 (75%)

0 (0%)

1 (25%)

4 (100%)

0 (0%)

0 (0%)

4 (100%)

0 (0%)

0.285

0.285

P

 

<0.001

<0.001

<0.001

  
  1. Abbreviations:ASCUS atypical squamous cells of undetermined significance, CIN cervical intraepithelial neoplasia, HPV human papillomavirus, HSIL high-grade squamous intraepithelial lesions, LSIL low-grade squamous intraepithelial lesions.
  2. aIncluding atypical squamous cells – cannot exclude HSIL, adenocarcinoma in situ, atypical glandular cells, cytological signs of carcinoma.
  3. bIncluding histological atypia and CIN not otherwise specified.
  4. cOr HPV genotypes not detectable by both CLART and LA (CLART: 43, 44, 85, 89; LA: 55, 64, 67, 69, IS39, CP6108).
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BMC Cancer

ISSN: 1471-2407

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