Table 2.
Comparison of and agreement between Amplicor and hc2 for the detection of carcinogenic HPV for all paired tests stratified by the enrollment cytology result and HPV risk group as detected by Linear Array (LA) and/or Line Blot Assay (LBA) for women referred into ALTS for an atypical squamous cell of undetermined significance (ASCUS) Pap at two Amplicor cutoffs (0.2 and 1.5)
| AMP 0.2/hc2, Cytology stratification | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Group | N | hc2+ (%) | Amp+ (%) | hc2+/AMP+ (%) | hc2+/AMP− (%) | hc2-/AMP+ (%) | hc2-/AMP− (%) | Kappa | Agreement (%) | p |
| All | 3,277 | 1,742 (53.16) | 2,102 (64.14) | 1,561 (47.64) | 181 (5.52) | 541 (16.51) | 994 (30.33) | 0.55 | 77.97 | <0.001 |
| ASC-US | 819 | 455 (55.56) | 534 (65.20) | 408 (49.82) | 47 (5.74) | 126 (15.38) | 238 (29.06) | 0.56 | 78.88 | <0.001 |
| LSIL | 576 | 530 (92.01) | 501 (86.98) | 485 (84.20) | 45 (7.81) | 16 (2.78) | 30 (5.21) | 0.44 | 89.41 | <0.001 |
| ASC-H | 128 | 104 (81.25) | 107 (83.59) | 97 (75.78) | 7 (5.47) | 10 (7.81) | 14 (10.94) | 0.54 | 86.72 | 0.47 |
| HSIL | 176 | 171 (97.16) | 172 (97.73) | 169 (96.02) | 2 (1.14) | 3 (1.70) | 2 (1.14) | 0.43 | 97.16 | 0.65 |
| AMP 0.2/hc2, HPV stratification | ||||||||||
| Group | N | hc2+ (%) | Amp+ (%) | hc2+/AMP+ (%) | hc2+/AMP− (%) | hc2-/AMP+ (%) | hc2-/AMP− (%) | Kappa | Agreement (%) | p |
| HPV16 | 577 | 501 (86.83) | 549 (95.15) | 496 (85.96) | 5 (0.87) | 53 (9.19) | 23 (3.99) | 0.40 | 89.95 | <0.001 |
| HPV18 | 160 | 124 (77.50) | 152 (95.00) | 121 (75.63) | 3 (1.88) | 31 (19.38) | 5 (3.13) | 0.16 | 78.75 | <0.001 |
| HR11 | 1056 | 842 (79.73) | 997 (94.41) | 831 (78.69) | 11 (1.04) | 166 (15.72) | 48 (4.55) | 0.29 | 83.24 | <0.001 |
| NonHR | 476 | 151 (31.72) | 120 (25.21) | 40 (8.40) | 111 (23.32) | 80 (16.81) | 245 (51.47) | 0.02 | 59.87 | 0.025 |
| Neg | 898 | 51 (5.68) | 206 (22.94) | 9 (1.00) | 42 (4.68) | 197 (21.94) | 650 (72.38) | −0.02 | 73.39 | <0.001 |
| AMP 1.5/hc2, Cytology stratification | ||||||||||
| Group | N | hc2+ (%) | Amp+ (%) | hc2+/AMP+ (%) | hc2+/AMP− (%) | hc2-/AMP+ (%) | hc2-/AMP− (%) | Kappa | Agreement (%) | p |
| All | 3,277 | 1742 (53.16) | 1,834 (55.97) | 1,470 (44.86) | 272 (8.30) | 364 (11.11) | 1171 (35.73) | 0.61 | 80.59 | <0.001 |
| ASC-US | 819 | 455 (55.56) | 464 (56.65) | 383 (46.76) | 72 (8.79) | 81 (9.89) | 283 (34.55) | 0.62 | 81.32 | 0.47 |
| LSIL | 576 | 530 (92.01) | 466 (80.90) | 454 (78.82) | 76 (13.19) | 12 (2.08) | 34 (5.90) | 0.36 | 84.72 | <0.001 |
| ASC-H | 128 | 104 (81.25) | 102 (79.69) | 95 (74.22) | 9 (7.03) | 7 (5.47) | 17 (13.28) | 0.60 | 87.50 | 0.62 |
| HSIL | 176 | 171 (97.16) | 166 (94.32) | 164 (93.18) | 7 (3.98) | 2 (1.14) | 3 (1.70) | 0.38 | 94.89 | 0.10 |
| AMP 1.5/hc2, HPV stratification | ||||||||||
| Group | N | hc2+ (%) | Amp+ (%) | hc2+/AMP+ (%) | hc2+/AMP− (%) | hc2-/AMP+ (%) | hc2-/AMP− (%) | Kappa | Agreement (%) | p |
| HPV16 | 577 | 501 (86.83) | 530 (91.85) | 483 (83.71) | 18 (3.12) | 47 (8.15) | 29 (5.03) | 0.41 | 88.73 | <0.001 |
| HPV18 | 160 | 124 (77.50) | 148 (92.50) | 119 (74.38) | 5 (3.13) | 29 (18.13) | 7 (4.38) | 0.20 | 78.75 | <0.001 |
| HR11 | 1056 | 842 (79.73) | 917 (86.84) | 790 (74.81) | 52 (4.92) | 127 (12.03) | 87 (8.24) | 0.40 | 83.05 | <0.001 |
| NonHR | 476 | 151 (31.72) | 58 (12.18) | 13 (2.73) | 138 (28.99) | 45 (9.45) | 280 (58.82) | −0.06 | 61.55 | <0.001 |
| Neg | 898 | 51 (5.68) | 112 (12.47) | 4 (0.45) | 47 (5.23) | 108 (12.03) | 739 (82.29) | −0.03 | 82.74 | <0.001 |
hc2: Hybrid Capture 2; AMP: Amplicor. HPV risk groups are determined by the presence of the respective type in LA or LBA. HR11: All targeted carcinogenic types without HPV16 and HPV18; NonHR: All HPV types except targeted carcinogenic types; Neg: negative for HPV by LA or LBA. Differences were tested for statistical significance using an exact McNemar’s χ2 test.