TABLE 5.

Comparison of HPV-Risk assay results for self-collected vaginal brush specimens and concomitantly clinician-obtained cervical scraping specimens, stratified for CIN2+

Histology result	HPV-Risk assay result for self-collected brush specimen	No. of clinician-obtained cervical scraping specimens with HPV-Risk assay resulta				No. of self-collected brush specimens with GP5+/6+ PCR resultb
		Invalid	Negative	Positive	Total	Negative	Positive	Total
≤CIN1	Negative	5	31	4	40	36	4	40
	Positive		2	36	38	2	36	38
	Total	5	33	40	78	38	40	78
CIN2+	Negative		2	1	3	2	1	3
	Positive		2	29	31	1	30	31
	Total		4	30	34	3	31	34
Overall	Negative	5	33	5	43	38	5	43
	Positive		4	65	69	3	66	69
	Total	5	37	70	112	41	71	112

^aAgreement between HPV-Risk assay results for self-collected and clinician-collected specimens was as follows: ≤CIN1, 92% (95% CI, 83 to 96%), 67/73 samples, kappa = 0.84; CIN2+, 91% (95% CI, 76 to 97%), 31/34 samples, kappa = 0.52; overall, 92% (95% CI, 85 to 96%), 98/107 samples, kappa = 0.82.

^bAgreement between HPV-Risk assay and GP5+/6+ PCR assay results was as follows: ≤CIN1, 92% (95% CI, 84 to 97%), 72/78 samples, kappa = 0.86; CIN2+, 94% (95% CI, 79 to 97%), 32/34 samples, kappa = 0.63; overall, 93% (95% CI, 86 to 96%), 104/112 samples, kappa = 0.86.