Table 3.

Performance of Onclarity vs HC2 for Detection of High-Grade CIN in Patients 30 Years or Older With NILM Cytology^a

	Unadjusted, % (95% CI)		Adjusted, % (95% CI)
Characteristic	Onclarity	HC2	Onclarity	HC2
≥CIN2
Sensitivity	87.5 (78.5-93.1) (n = 70/80)	82.5 (72.7-89.3) (n = 66/80)	44.1 (27.7-77.8)	40.3 (25.2-69.0)
Specificity	48.6 (46.7-50.6) (n = 1,220/2,508)	52.3 (50.4-54.3) (n = 1,312/2,508)	92.4 (92.1-92.8)	93.4 (93.1-93.8)
PPV	5.2 (4.6-5.5) (n = 70/1,358)	5.2 (4.6-5.7) (n = 66/1,262)	5.0 (3.9-6.1)	5.3 (4.1-6.5)
NPV	99.2 (98.6-99.5) (n = 1,220/1,230)	98.9 (98.4-99.4) (n = 1,312/1,326)	99.5 (98.9-99.9)	99.4 (98.9-99.8)
PLR	1.7 (1.5-1.8)	1.7 (1.5-1.9)	5.8 (3.7-10.2)	6.1 (3.8-10.6)
NLR	0.3 (0.1-0.4)	0.3 (0.2-0.5)	0.6 (0.2-0.8)	0.6 (0.3-0.8)
Prevalence		3.1 (n = 80/2,588)		0.9
≥CIN3
Sensitivity	93.5 (82.5-97.8) (n = 43/46)	87.0 (74.3-93.9) (n = 40/46)	69.5 (42.8-100)	63.3 (38.7-94.9)
Specificity	48.3 (46.3-50.2) (n = 1,227/2,542)	51.9 (50.0-53.9) (n = 1,320/2,542)	92.3 (92.0-92.7)	93.3 (93.0-93.7)
PPV	3.2 (2.8-3.4) (n = 43/1,358)	3.2 (2.7-3.5) (n = 40/1,262)	3.0 (2.2-4.0)	3.2 (2.3-4.2)
NPV	99.8 (99.3-99.9) (n = 1,227/1,230)	99.5 (99.1-99.8) (n = 1,320/1,326)	99.9 (99.7-100)	99.9 (99.7-100)
PLR	1.8 (1.6-1.9)	1.8 (1.5-2.0)	9.1 (5.5-13.2)	9.5 (5.8-14.4)
NLR	0.1 (0.1-0.4)	0.3 (0.1-0.5)	0.3 (0.0-0.6)	0.4 (0.1-0.7)
Prevalence		1.8 (n = 46/2,588)		0.3

CI, confidence interval; CIN2, cervical intraepithelial neoplasia grade 2; CIN3, cervical intraepithelial neoplasia grade 3; HC2, digene Hybrid Capture 2 assay; NILM, negative for intraepithelial lesion or malignancies; NLR, negative likelihood ratio NPV, negative predictive value; PLR, positive likelihood ratio; PPV, positive predictive value.

^aResults represent p16^INK4A immunostain-assisted adjudicated histology with HPV results by Onclarity and HC2 assays (paired analysis).