Table 3.

Relative sensitivities for detection of CIN2+ and CIN3+ and relative specificity for detection of ≤CIN1 of INNO-LiPA versus HC2. Analysis was performed separately for the total study population and for women ≥30 years old.

INNO-LiPA vs. HC2	Relative Sensitivity	Relative Specificity	p mcn a	p n.inf b
Total study population
CIN2+	1.01 (0.97–1.04)		0.6547	0.0002
CIN3+	1.01 (0.97–1.06)		0.5637	0.001
≤CIN1		0.95 (0.93–0.97)	<0.001	0.9998
Women > 30 years old
CIN2+	1.01 (0.96–1.06)		0.6547	0.001
CIN3+	1.02 (0.96–1.07)		0.5637	0.003
≤CIN1		0.95 (0.93–0.97)	<0.001	0.999

^ap for the McNemar test for a difference between matched proportions and p_mcn > 0.05 indicates that the sensitivity or specificity of the INNO-LiPA assay are not significantly different from that of the HC2. ^b p for the test for non-inferiority. A sensitivity threshold of at least 90% and a specificity threshold of at least 98% relative to that of the HC2 were applied in a non-inferiority score test. p_n.inf < 0.05 means that the sensitivity or specificity of the INNO-LiPa is not significantly lower than that of the HC2.