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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).