Table 4.
Agreement (concordance and κ values) between the INNO-LiPA and the Linear Array for overall hrHPV positivity and for 29 individual HPV types common to both assays in the total study population.
| HPV Type | I+/L+ | I+/L− | I−/L+ | I−/L− | Concordance | κ (95% CI) | p mcn a |
|---|---|---|---|---|---|---|---|
| 13 hrHPV b | 318 | 103 | 9 | 1166 | 93.0% | 0.805 (0.757–0.854) | <0.001 |
| HPV16 | 112 | 16 | 2 | 1466 | 99.0% | 0.920 (0.871–0.969) | 0.001 |
| HPV18 | 31 | 6 | 3 | 1556 | 99.4% | 0.870 (0.822–0.920) | 0.3173 |
| HPV31 | 68 | 50 | 1 | 1417 | 96.8% | 0.712 (0.664–0.759) | <0.001 |
| HPV33 | 24 | 13 | 1 | 1558 | 99.2% | 0.770 (0.722–0.818) | 0.0013 |
| HPV35 | 5 | 0 | 0 | 1591 | 100.0% | 1.000 (0.951–1.049) | 1.0000 |
| HPV39 | 15 | 9 | 2 | 1570 | 99.1% | 0.728 (0.680–0.777) | 0.0348 |
| HPV45 | 14 | 6 | 0 | 1576 | 99.6% | 0.822 (0.774–0.870) | 0.0143 |
| HPV51 | 33 | 16 | 1 | 1546 | 98.9% | 0.790 (0.742–0.838) | <0.001 |
| HPV52 | 30 | 26 | 2 | 1538 | 94.6% | 0.674 (0.633–0.714) | 0.8840 |
| HPV56 | 16 | 9 | 7 | 1564 | 99.0% | 0.662 (0.613–0.712) | 0.6171 |
| HPV58 | 19 | 5 | 0 | 1572 | 99.7% | 0.882 (0.833–0.931) | 0.0253 |
| HPV59 | 17 | 2 | 2 | 1575 | 99.8% | 0.894 (0.845–0.943) | 1.0000 |
| HPV68 | 7 | 26 | 0 | 1563 | 98.4% | 0.345 (0.308–0.382) | <0.001 |
| HPV26 c | 0 | 0 | 0 | 1596 | 100.0% | - | 1.0000 |
| HPV53 | 43 | 23 | 1 | 1529 | 98.5% | 0.774 (0.726–0.822) | <0.001 |
| HPV66 | 29 | 16 | 1 | 1550 | 98.9% | 0.768 (0.720–0.816) | <0.001 |
| HPV70 | 11 | 10 | 0 | 1575 | 99.4% | 0.685 (0.638–0.731) | 0.0016 |
| HPV73 | 19 | 7 | 2 | 1570 | 99.4% | 0.788 (0.739–0.837) | 0.0956 |
| HPV82 | 5 | 4 | 1 | 1586 | 99.7% | 0.665 (0.617–0.713) | 0.1797 |
| HPV06 | 7 | 14 | 1 | 1574 | 99.1% | 0.479 (0.435–0.523) | 0.0008 |
| HPV11 | 2 | 3 | 0 | 1591 | 99.8% | 0.571 (0.526–0.615) | 0.0833 |
| HPV40 | 1 | 4 | 0 | 1591 | 99.8% | 0.333 (0.296–0.369) | 0.0455 |
| HPV42 | 3 | 5 | 9 | 1579 | 99.1% | 0.296 (0.248–0.344) | 0.2850 |
| HPV54 | 10 | 14 | 12 | 1560 | 98.4% | 0.427 (0.378–0.476) | 0.6949 |
| HPV61 | 16 | 17 | 6 | 1557 | 98.6% | 0.575 (0.527–0.623) | 0.0218 |
| HPV62 | 15 | 12 | 9 | 1560 | 98.7% | 0.582 (0.533–0.632) | 0.5127 |
| HPV67 | 3 | 5 | 1 | 1587 | 99.6% | 0.498 (0.452–0.543) | 0.1025 |
| HPV81 | 3 | 3 | 1 | 1589 | 99.8% | 0.599 (0.551–0.647) | 0.3173 |
| HPV83 | 0 | 6 | 3 | 1587 | 99.4% | −0.003 (−0.049–0.044) | 0.3173 |
I+ = INNO-LiPA positive; I− = INNO-LiPA negative; L+ = Linear Array positive; L− = Linear Array negative. Color legend (adapted from Landis and Koch for the levels of agreement [25]): dark green (1.00 ≥ κ >0.80): excellent; light green (0.80 ≥ κ > 0.60): good; yellow (0.60 ≥ κ > 0.40): moderate; orange (0.40 ≥ κ > 0.20): fair; red (0.20 ≥ κ > 0.00): poor. a p for the McNemar test for a difference between matched proportions and pmcn < 0.05 indicates that the HPV positivity detected by INNO-LiPA is significantly different from that of the Linear Array. b 13 hrHPV types: HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59 and HPV68. c No HPV26 positive cases detected by both assays, κ value not applicable.