Table 2.
Clinical performance of carcinogenic HPV detection by Linear Array (LA) and Hybrid Capture 2 (hc2) for enrollment ≥CIN3 as diagnosed by QC pathology and ≥CIN2 as diagnosed by clinical center pathologists in women referred into ALTS for an ASCUS Pap and restricted to women participating in the IC arm (n = 1,089). Differences in sensitivity, specificity, and referral were tested for statistical significance using an exact McNemar's χ2 test. Statistical differences in positive (PPV) and negative (NPV) predictive values were a method developed by Leisenring et al. (36), a score statistic derived from a marginal regression model and bears some relation to McNemar's statistic.
| Linear Array | hc2 | ||||
|---|---|---|---|---|---|
| Estimate | 95%CI | Estimate | 95%CI | P | |
| QC Pathology ≥CIN3 (n = 55) | |||||
| Sensitivity | 89.1% | 77.8%-95.9% | 90.9% | 80.0%-97.0% | 1 |
| Specificity | 46.5% | 43.4%-49.6% | 47.8% | 44.7%- 50.9% | 0.3 |
| PPV | 8.1% | 6.1%-10.6% | 8.5% | 6.4%-11.0% | 0.0009 |
| NPV | 98.77% | 97.34%-99.55% | 99.00% | 97.68%-99.67% | 0.8 |
| Referral | 55.3% | 52.3%-58.3% | 54.2% | 51.2%-57.2% | 0.4 |
| CC Pathology ≥CIN2 (n = 113) | |||||
| Sensitivity | 87.6% | 80.1%-93.1% | 89.5% | 82.3%-94.4% | 0.8 |
| Specificity | 48.2% | 45.0%-51.3% | 50.0% | 46.8%-53.2% | 0.3 |
| PPV | 16.3% | 13.4%-19.5% | 17.3% | 14.3%-20.6% | <0.0001 |
| NPV | 97.12% | 95.22%-98.42% | 97.60% | 95.84%-98.75% | 0.8 |
| Referral | 55.5% | 52.5%-58.5% | 54.1% | 51.1%-57.1% | 0.4 |