Table 2.
Accuracy for cervical precancer based on Pap cytology and manual and automated detection of DS-positive cells on SurePath slides in the Kaiser Validation Study (N = 3095)
| Evaluation | Colposcopy referral, No. (%) | P a (cytology/manual DS) | Sensitivity, % (95% CI) | P a (cytology/manual DS) | Specificity, % (95% CI) | P a (cytology/manual DS) | PPV, % (95% CI) | P b (cytology/ manual DS) | NPV, % (95% CI) | P b (cytology/manual DS) | Colposcopies per CIN3+ detected, No. (95% CI) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pap cytology (188 CIN3+) | 1860 (60.1) | Ref | 85.8 (81.2 to 90.5) | Ref | 41.9 (40.1 to 43.7) | Ref | 10.1 (8.7 to 11.5) | Ref | 97.5 (96.6 to 98.3) | Ref | 9.9 (8.7 to 11.3) |
| Manual DS (197 CIN3+) | 1536 (49.6) | <.001/ Ref | 90.0 (86.0 to 93.9) | .2/Ref | 52.6 (50.8 to 54.5) | <.001/ Ref | 12.6 (11.0 to 14.3) | <.001/ Ref | 98.6 (98.0 to 99.2) | .02/Ref | 7.8 (6.8 to 8.9) |
| Automated DS (2 cells) (192 CIN3+) | 1298 (41.9) | <.001/ <.001 | 88.1 (82.5 to 91.7) | .6/.4 | 61.5 (59.7 to 63.3) | <.001/ <.001 | 14.8 (12.9 to 16.8) | <.001/ <.001 | 98.5 (97.8 to 99.0) | .03/.8 | 6.8 (5.9 to 7.7) |
| Automated DS (1 cell) (201 CIN3+) | 1741 (56.3) | .007/ <.001 | 91.8 (87.3 to 95.1) | .05/.5 | 46.5 (44.6 to 48.3) | .06/ <.001 | 11.5 (10.1 to 13.1) | .002/ <.001 | 98.7 (97.9 to 99.2) | .01/.5 | 8.7 (7.6 to 9.9) |
a
Two-sided McNemar’s test. CIN3+ = cervical intraepithelial neoplasia grade 3 or worse; DS = dual stain; NPV = negative predictive value; PPV = positive predictive value; Ref = referent.
b
Two-sided generalized score statistic.