Clinical validation of full HR-HPV genotyping HPV Selfy assay according to the international guidelines for HPV test requirements for cervical cancer screening on clinician-collected and self-collected samples

Table 4 Clinical validation of HPV Selfy for self-collection according to VALHUDES indications. Results of HPV Selfy assay performed on self-collected vaginal specimen vs ThinPrep cervical samples, performed on 910 paired samples from population-based screening stratified by case–control status

Controls		HPV Selfy (clinician-collected cervical samples)		Total
		Negative	Positive
HPV Selfy (self-collected vaginal samples)	Negative	708	16	724
HPV Selfy (self-collected vaginal samples)	Positive	37	30	67
	Total	745	46	791

CIN2+
HPV Selfy (self-collected vaginal samples)	Negative	18	13	31
HPV Selfy (self-collected vaginal samples)	Positive	5	83	88
	Total	23	96	119

ISSN: 1479-5876