Background
Methods
HPV testing
Statistical analyses
Ethical approval
Results
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 |
Detection of HPV genotypes
Genotype | Prevalence | Agreement | |||||||
---|---|---|---|---|---|---|---|---|---|
CLART, N (%) | LA, N (%) | Relative prevalence CLART vs. LA (95% CI) | CLART+/LA+ | CLART+/LA- | CLART-/LA+ | CLART-/LA- | Total agreement (95% CI) | Positive agreement (95% CI) | |
High-risk
| |||||||||
16 | 121 (30%) | 126 (31%) | 0.96 (0.78-1.18) | 120 (30%) | 1 (0%) | 6 (1%) | 274 (68%) | 98% (96-99) | 94% (89-98) |
18 | 45 (11%) | 53 (13%) | 0.85 (0.59-1.23) | 45 (11%) | 0 (0%) | 8 (2%) | 348 (87%) | 98% (96-99) | 85% (72-93) |
31 | 64 (16%) | 61 (15%) | 1.05 (0.76-1.45) | 61 (15%) | 3 (1%) | 0 (0%) | 337 (84%) | 99% (98-100) | 95% (87-99) |
33 | 42 (10%) | 40 (10%) | 1.05 (0.70-1.58) | 39 (10%) | 3 (1%) | 1 (0%) | 358 (89%) | 99% (97-100) | 91% (78-97) |
35 | 19 (5%) | 16 (4%) | 1.19 (0.62-2.28) | 16 (4%) | 3 (1%) | 0 (0%) | 382 (95%) | 99% (98-100) | 84% (60-97) |
39 | 22 (5%) | 48 (12%) | 0.46 (0.28-0.74) | 22 (5%) | 0 (0%) | 26 (6%) | 353 (88%) | 94% (91-96) | 46% (31-61) |
45 | 16 (4%) | 35 (9%) | 0.46 (0.26-0.81) | 16 (4%) | 0 (0%) | 19 (5%) | 366 (91%) | 95% (93-97) | 46% (29-63) |
51 | 47 (12%) | 50 (12%) | 0.94 (0.65-1.37) | 46 (11%) | 1 (0%) | 4 (1%) | 350 (87%) | 99% (97-100) | 90% (79-97) |
52 | 49 (12%) | 40 (10%) | 1.23 (0.83-1.82) | 33 (8%) | 16 (4%) | 7 (2%) | 345 (86%) | 94% (92-96) | 59% (45-72) |
56 | 30 (7%) | 39 (10%) | 0.77 (0.49-1.21) | 27 (7%) | 3 (1%) | 12 (3%) | 359 (90%) | 96% (94-98) | 64% (48-78) |
58 | 59 (15%) | 40 (10%) | 1.48 (1.01-2.15) | 38 (9%) | 21 (5%) | 2 (0%) | 340 (85%) | 94% (92-96) | 62% (49-74) |
59 | 27 (7%) | 29 (7%) | 0.93 (0.56-1.54) | 20 (5%) | 7 (2%) | 9 (2%) | 365 (91%) | 96% (94-98) | 56% (38-72) |
68 | 25 (6%) | 16 (4%) | 1.56 (0.85-2.88) | 6 (1%) | 19 (5%) | 10 (2%) | 366 (91%) | 93% (90-95) | 17% (7-34) |
Low-risk
| |||||||||
6 | 15 (4%) | 13 (3%) | 1.15 (0.56-2.39) | 12 (3%) | 3 (1%) | 1 (0%) | 385 (96%) | 99% (97-100) | 75% (48-93) |
11 | 4 (1%) | 4 (1%) | 1.00 (0.25-3.97) | 4 (1%) | 0 (0%) | 0 (0%) | 397 (99%) | 100% (99-100) | 100% (40-100) |
26 | 3 (1%) | 3 (1%) | 1.00 (0.20-4.93) | 3 (1%) | 0 (0%) | 0 (0%) | 398 (99%) | 100% (99-100) | 100% (29-100) |
40 | 5 (1%) | 6 (1%) | 0.83 (0.26-2.71) | 5 (1%) | 0 (0%) | 1 (0%) | 395 (99%) | 100% (99-100) | 83% (36-100) |
42 | 20 (5%) | 28 (7%) | 0.71 (0.41-1.25) | 20 (5%) | 0 (0%) | 8 (2%) | 373 (93%) | 98% (96-99) | 71% (51-87) |
53 | 50 (12%) | 52 (13%) | 0.96 (0.67-1.38) | 48 (12%) | 2 (0%) | 4 (1%) | 347 (87%) | 99% (97-99) | 89% (77-96) |
54 | 15 (4%) | 36 (9%) | 0.42 (0.23-0.75) | 14 (3%) | 1 (0%) | 22 (5%) | 364 (91%) | 94% (92-96) | 38% (22-55) |
61 | 34 (8%) | 44 (11%) | 0.77 (0.50-1.18) | 34 (8%) | 0 (0%) | 10 (2%) | 357 (89%) | 98% (95-99) | 77% (62-89) |
62 | 12 (3%) | 30 (7%) | 0.40 (0.21-0.77) | 12 (3%) | 0 (0%) | 18 (4%) | 371 (93%) | 96% (93-97) | 40% (23-59) |
66 | 44 (11%) | 40 (10%) | 1.10 (0.73-1.65) | 37 (9%) | 7 (2%) | 3 (1%) | 354 (88%) | 98% (95-99) | 79% (64-89) |
70 | 28 (7%) | 24 (6%) | 1.17 (0.69-1.98) | 24 (6%) | 4 (1%) | 0 (0%) | 373 (93%) | 99% (97-100) | 86% (67-96) |
71 | 1 (0% | 2 (0%) | 0.50 (0.05-5.49) | 0 (0%) | 1 (0%) | 2 (0%) | 398 (99%) | 99% (98-100) | 0% (0-71) |
72 | 1 (0%) | 1 (0%) | 1.00 (0.06-15.93) | 1 (0%) | 0 (0%) | 0 (0%) | 400 (100%) | 100% (99-100) | 100% (3-100) |
73 | 11 (3%) | 31 (8%) | 0.35 (0.18-0.70) | 11 (3%) | 0 (0%) | 20 (5%) | 370 (92%) | 95% (92-97) | 35% (19-55) |
81 | 12 (3%) | 14 (3%) | 0.86 (0.40-1.83) | 12 (3%) | 0 (0%) | 2 (0%) | 387 (97%) | 100% (98-100) | 86% (57-98) |
82 | 47 (12%) | 21 (5%) | 2.24 (1.36-3.67) | 20 (5%) | 27 (7%) | 1 (0%) | 353 (88%) | 93% (90-95) | 42% (28-57) |
83 | 15 (4%) | 14 (3%) | 1.07 (0.52-2.19) | 12 (3%) | 3 (1%) | 2 (0%) | 384 (96%) | 99% (97-100) | 71% (44-90) |
84 | 15 (4%) | 26 (6%) | 0.58 (0.31-1.07) | 15 (4%) | 0 (0%) | 11 (3%) | 375 (94%) | 97% (95-99) | 58% (37-77) |
High-risk genotype | Prevalence | Agreement | |||||||
---|---|---|---|---|---|---|---|---|---|
CLART, N (%) | LA, N (%) | Relative prevalence CLART vs. LA (95% CI) | CLART+/LA+ | CLART+/LA- | CLART-/LA+ | CLART-/LA- | Total agreement (95% CI) | Positive agreement (95% CI) | |
16 | 55 (44%) | 57 (46%) | 0.96 (0.73-1.27) | 55 (44%) | 0 (0%) | 2 (2%) | 68 (54%) | 98% (94-100) | 96% (88-100) |
18 | 18 (14%) | 18 (14%) | 1.00 (0.55-1.83) | 18 (14%) | 0 (0%) | 0 (0%) | 107 (86%) | 100% (97-100) | 100% (81-100) |
31 | 30 (24%) | 30 (24%) | 1.00 (0.64-1.55) | 30 (24%) | 0 (0%) | 0 (0%) | 95 (76%) | 100% (97-100) | 100% (88-100) |
33 | 21 (17%) | 22 (18%) | 0.95 (0.55-1.64) | 21 (17%) | 0 (0%) | 1 (1%) | 103 (82%) | 99% (96-100) | 95% (77-100) |
35 | 7 (6%) | 6 (5%) | 1.17 (0.40-3.37) | 6 (5%) | 1 (1%) | 0 (0%) | 118 (94%) | 99% (96-100) | 86% (42-100) |
39 | 4 (3%) | 12 (10%) | 0.33 (0.11-1.01) | 4 (3%) | 0 (0%) | 8 (6%) | 113 (90%) | 94% (88-97) | 33% (10-65) |
45 | 6 (5%) | 17 (14%) | 0.35 (0.14-0.87) | 6 (5%) | 0 (0%) | 11 (9%) | 108 (86%) | 91% (85-96) | 35% (14-62) |
51 | 15 (12%) | 17 (14%) | 0.88 (0.46-1.69) | 15 (12%) | 0 (0%) | 2 (2%) | 108 (86%) | 98% (94-100) | 88% (64-99) |
52 | 17 (14%) | 15 (12%) | 1.13 (0.59-2.17) | 11 (9%) | 6 (5%) | 4 (3%) | 104 (83%) | 92% (86-96) | 52% (30-74) |
56 | 6 (5%) | 9 (7%) | 0.67 (0.24-1.82) | 5 (4%) | 1 (1%) | 4 (3%) | 115 (92%) | 96% (91-99) | 50% (19-81) |
58 | 19 (15%) | 10 (8%) | 1.90 (0.92-3.92) | 10 (8%) | 9 (7%) | 0 (0%) | 106 (85%) | 93% (87-97) | 53% (29-76) |
59 | 9 (7%) | 10 (8%) | 0.90 (0.38-2.14) | 8 (6%) | 1 (1%) | 2 (2%) | 114 (91%) | 98% (93-100) | 73% (39-94) |
68 | 7 (6%) | 3 (2%) | 2.33 (0.62-8.82) | 0 (0%) | 7 (6%) | 3 (2%) | 115 (92%) | 92% (86-96) | 0% (0-31) |
LA | CLART | Total | ||
---|---|---|---|---|
Single infection | Multiple infection | No HPV genotypea | ||
Single infection
| 89 | 19 | 13 | 121 (30%) |
Multiple infection
| 40 | 216 | 3 | 259 (65%) |
No HPV genotype
a
| 1 | 0 | 20 | 21 (5%) |
Total
| 130 (32%) | 235 (59%) | 36 (9%) | 401 (100%) |
LA | CLART | Total | ||
---|---|---|---|---|
High-risk genotypes | Low-risk genotypes | No genotypesa | ||
High-risk genotypes
| 306 | 12 | 8 | 326 (81%) |
Low-risk genotypes
| 5 | 41 | 8 | 54 (13%) |
No genotypes
a
| 0 | 1 | 20 | 21 (5%) |
Total
| 311 (78%) | 54 (13%) | 36 (9%) | 401 (100%) |
Genotyping assay | Assay+/HC2+ | Assay+/HC2- | Assay-/HC2+ | Assay-/HC2- |
---|---|---|---|---|
401 women with abnormal cytology
| ||||
CLART | 301 (75%) | 10 (2%) | 54 (13%) | 36 (9%) |
LA | 315 (79%) | 11 (3%) | 40 (10%) | 35 (9%) |
125 women with ≥ CIN2
| ||||
CLART | 116 (93%) | 0 (0%) | 7 (6%) | 2 (2%) |
LA | 120 (96%) | 0 (0%) | 3 (2%) | 2 (2%) |
Detection of cervical lesions
CLART | LA | HC2 | |
---|---|---|---|
Endpoint: ≥CIN2
| |||
Sensitivity (95% CI) | 0.93 (0.87-0.97) | 0.96 (0.91-0.99) | 0.98 (0.94-1.00) |
Relative sensitivity vs. LA | 0.97 (0.91-1.03) | 1.0 (ref) | 1.03 (0.98-1.07) |
Relative sensitivity vs. HC2 | 0.94 (0.89-1.00) | 0.98 (0.94-1.02) | 1.0 (ref) |
Specificity | 0.30 (0.25-0.36) | 0.26 (0.21-0.32) | 0.17 (0.12-0.22) |
Relative Specificity vs. LA | 1.16 (0.88-1.54) | 1.0 (ref) | 0.64 (0.46-0.90) |
Relative Specificity vs. HC2 | 1.81 (1.30-2.52) | 1.56 (1.11-2.19) | 1.0 (ref) |
Endpoint ≥ CIN3
| |||
Sensitivity (95% CI) | 0.93 (0.86-0.98) | 0.97 (0.91-0.99) | 0.99 (0.94-1.00) |
Relative sensitivity vs. LA | 0.97 (0.90-1.03) | 1.0 (ref) | 1.02 (0.98-1.07) |
Relative sensitivity vs. HC2 | 0.94 (0.89-1.00) | 0.98 (0.94-1.02) | 1.0 (ref) |
Specificity | 0.28 (0.23-0.33) | 0.23 (0.19-0.29) | 0.15 (0.11-0.20) |
Relative Specificity vs. LA | 1.17 (0.89-1.55) | 1.0 (ref) | 0.64 (0.45-0.90) |
Relative Specificity vs. HC2 | 1.84 (1.32-2.56) | 1.57 (1.11-2.21) | 1.0 (ref) |