Table 3.

Clinical performance of carcinogenic HPV detection by LA and hc2 for 2-year cumulative ≥CIN3 as diagnosed by QC Pathology (n = 3,289) and ≥CIN2 as diagnosed by clinical center pathologists (n = 2,189, restricted to women in the IC and HPV arms) referred into ALTS for an ASCUS Pap

LA
hc2
P
Estimate (%)95% CIEstimate (%)95% CI
QC Pathology ≥CIN3 (n = 285)
    Sensitivity93.389.8-95.992.689.0-95.41
    Specificity48.146.3-49.950.648.8-52.40.05
    PPV14.613.0-16.315.113.4-16.9<0.0001
    NPV98.7097.98-99.2298.6497.92-99.150.4
    Referral55.553.7-57.253.251.5-54.90.001
CC Pathology ≥CIN2 (n = 354)
    Sensitivity87.883.9-91.191.087.5-93.80.09
    Specificity50.448.1-52.753.150.8-55.40.007
    PPV24.822.4-27.326.524.0-29.2<0.0001
    NPV95.6894.20-96.8796.9395.67-97.910.8
    Referral55.653.5-57.753.951.7-56.00.04
  • NOTE: 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 determined by 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.