Table 3

Clinical accuracy of the Papilloplex HPV test for detection of CIN2+ and CIN3+ compared with to GP5+/6+EIA

Papilloplex HR HPVGp5+/6+Relative accuracyPMcNPni
PositiveNegativeTotal
Sensitivity
≥CIN2
Positive11131141.018 (0.98–1.05)0.6250.0001
Negative145
Total1127119
Sensitivity
≥CIN3
Positive782801.026 (0.99–1.06)0.5000.0005
Negative022
Total78482
Specificity
≤CIN1
Positive6229911.003 (0.98–1.02)0.8970.0167
Negative31712743
Total93741834
  • Sensitivity for histologically confirmed ≥CIN2 (n=119) or ≥CIN3 (n=82), specificity for ≤CIN1 considering women with two consecutive negative cytology (at enrolment and at previous screening) as free of ≥CIN2 (n=834). PMcN=McNemar χ2 test; Pni=matched non-inferiority test.

  • CIN2, cervical intraepithelial neoplasia grade 2; EIA, enzyme immunoassay; HPV, human papillomavirus.