TABLE 5.
Clinical performance of carcinogenic HPV detection by LA and LBA for 2-year cumulative CIN3 or worse as diagnosed by QC pathology and CIN2 or more as diagnosed by clinical center pathologistsa
| Parameter | LA
|
LBA
|
P | ||
|---|---|---|---|---|---|
| Estimate (%) | 95% CI (%) | Estimate (%) | 95% CI (%) | ||
| QC pathology CIN3 or worse | |||||
| Sensitivity | 92.3 | 88.6-95.1 | 87.1 | 82.7-90.8 | 0.003 |
| Specificity | 48.2 | 46.4-50.0 | 54.0 | 52.2-55.8 | <0.0001 |
| PPV | 14.4 | 12.8-16.1 | 15.1 | 13.4-17.0 | 0.0004 |
| NPV | 98.52 | 97.77-99.07 | 97.80 | 96.98-98.45 | 0.04 |
| Referral | 55.3 | 53.6-57.0 | 49.5 | 47.8-51.2 | <0.0001 |
| Clinical-center pathology CIN2 or worseb | |||||
| Sensitivity | 87.5 | 83.5-90.8 | 84.3 | 80.0-88.0 | 0.09 |
| Specificity | 50.7 | 48.4-53.0 | 56.6 | 54.3-58.8 | <0.0001 |
| PPV | 24.6 | 22.2-27.1 | 26.2 | 23.7-28.9 | <0.0001 |
| NPV | 95.67 | 94.22-96.85 | 95.16 | 93.73-96.34 | 0.8 |
| Referral | 55.2 | 53.1-57.3 | 49.8 | 47.7-51.9 | <0.0001 |
a
Differences in sensitivity, specificity, and referral were tested for statistical significance using an exact McNemar's χ2 test. Statistical differences in PPV and NPV were tested for statistical significance using a method developed by Leisenring et al. (31), a score statistic derived from a marginal regression model that bears some relation to McNemar's statistic.
b
Included only the 2,225 women in the immediate-colposcopy and HPV study arms of ALTS.