Table 2.
Clinical performance of dual stain and Pap cytology for detection of cervical precancer among 1509 HPV-positive women*
| Statistical measures | p16/Ki-67 dual stain 1+ (95% CI) |
Liquid-based cytology ASCUS+ (95% CI) | P |
|---|---|---|---|
| Positivity | 694 (46.0% [43.5% to 48.5%]) | 806 (53.4% [50.9% to 55.9%]) | <.001 |
| Detection of CIN2+ (n = 175) | |||
| Sensitivity | 83.4% (77.1% to 88.6%) | 76.6% (69.6% to 82.6%) | .1 |
| Specificity | 58.9% (56.2% to 61.6%) | 49.6% (46.9% to 52.3%) | <.001 |
| PPV | 21.0% (18.1% to 24.3%) | 16.6% (14.1% to 19.4%) | <.001 |
| NPV | 96.4% (94.9% to 97.6%) | 94.2% (92.2% to 95.8%) | .01 |
| LR+ | 2.0 (1.9 to 2.2) | 1.5 (1.4 to 1.7) | |
| LR- | 0.3 (0.2 to 0.4) | 0.5 (0.4 to 0.6) | |
| OR | 7.2 (4.8 to 11.0) | 3.2 (2.2 to 4.6) | |
| Detection of CIN3+ (n = 99) | |||
| Sensitivity | 86.9% (78.6% to 92.8%) | 83.8% (75.1% to 90.5%) | .7 |
| Specificity | 56.9% (54.2% to 59.5%) | 48.7% (46.1% to 51.4%) | <.001 |
| PPV | 12.4% (10.0% to 15.1%) | 10.3% (8.3% to 12.6%) | .002 |
| NPV | 98.4% (97.3% to 99.1%) | 97.7% (96.3% to 98.7%) | .3 |
| LR+ | 2.0 (1.8 to 2.2) | 1.6 (1.5 to 1.8) | |
| LR- | 0.2 (0.1 to 0.4) | 0.3 (0.2 to 0.5) | |
| OR | 8.7 (4.9 to 15.7) | 4.9 (2.9 to 8.5) | |
* P values for positivity, sensitivity, and specificity are based on McNemar’s Chi-square test. P values for positive predictive value and negative predictive value are based on the method developed by Leisenring and Pepe (14). All statistical tests were two-sided. LR+ = likelihood ratio–positive; LR- = likelihood ratio–negative; NPV = negative predictive value; PPV = positive predictive value; OR = odds ratio.