Table 2.

Clinical performance of carcinogenic HPV detection by LA and 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)

LA
hc2
P
Estimate (%)95% CIEstimate (%)95% CI
QC Pathology ≥CIN3 (n = 55)
    Sensitivity89.177.8-95.990.980.0-97.01
    Specificity46.543.4-49.647.844.7-50.90.3
    PPV8.16.1-10.68.56.4-11.00.0009
    NPV98.7797.34-99.5599.0097.68-99.670.8
    Referral55.352.3-58.354.251.2-57.20.4
CC Pathology ≥CIN2 (n = 113)
    Sensitivity87.680.1-93.189.582.3-94.40.8
    Specificity48.245.0-51.350.046.8-53.20.3
    PPV16.313.4-19.517.314.3-20.6<0.0001
    NPV97.1295.22-98.4297.6095.84-98.750.8
    Referral55.552.5-58.554.151.1-57.10.4
  • 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.