Table 5.

Comparison of Different Regulatory Trials Involving Women With NILM Cytology (≥30 Years of Age)^a

Characteristic	Aptimab,38,39	Cobasc,29,40	Onclarity
Cytology media	ThinPrep	ThinPrep	SurePath
No. of patients	10,871	32,260	22,284
Mean age, y	44.2	44.9	43.9
HPV+, %	5.0	6.7	7.9
HPV 16+, %	0.4d	1.0	1.5
HPV 18+, %	NR	0.5	0.4
HPV 16/18+, %	NR	1.5	1.9
HPV 45+, %	NR	NR	0.5
HPV 18/45+, %	0.4d	NR	0.9
CIN2, No.	9	51e	34
≥CIN3, No.	11	80e	46
No. of cancer cases	3	NR	5f
For ≥CIN2, % (95% CI)
Sensitivity	75.0 (53.1-88.8)	83.2 (75.9-88.6)e	87.5 (78.5-93.1)
Specificity	62.6 (59.2-65.9)	60.4 (58.9-61.9)e	48.6 (46.7-50.6)
For ≥CIN3, % (95% CI)
Sensitivity	90.9 (62.3-98.4)	90.0 (81.5-94.8)e	93.5 (82.5-97.8)
Specificity	62.4 (59.0-65.7)	60.0 (58.5-61.5)e	48.3 (46.3-50.2)

CI, confidence interval; CIN2, cervical intraepithelial neoplasia grade 2; CIN3, cervical intraepithelial neoplasia grade 3; HPV, human papillomavirus; NILM, negative for intraepithelial lesion or malignancies; NR, not reported.

^aBaseline data unless otherwise indicated.

^bData obtained from Aptima package insert unless otherwise noted.

^cData obtained from Wright et al²⁹ unless otherwise noted.

^dBased on Aptima 16, 18/45 package insert (n = 10,846).

^eData obtained from cobas package insert.

^fIndicates adenocarcinoma in situ cases.