Table 2.

The Concordance Between the RDLA and E1 Assay for Detection of Vaccine and Non-Vaccine HPV Types by Case Status

HPV Groups	Case Status	Number of Study Participants	HR-HPV Results (RDLA/E1)				Crude Concordance	Gwet’s AC1 Agreement
			+/+	-/-	+/-	-/+
Any HR-HPV	<CIN 1	83	32	28	18	5	0.72 (0.63–0.82)	0.45 (0.25–0.64)
	CIN 1	273	144	65	50	14	0.76 (0.71–0.80)	0.54 (0.45–0.63)
	CIN 2	93	80	4	7	2	0.90 (0.84–0.96)	0.88 (0.80–0.96)
	CIN 3	74	60	1	11	2	0.82 (0.74–0.91)	0.79 (0.66–0.91)
HPV 16 or 18 positive	<CIN 1	46	9	28	4	5	0.80 (0.69–0.92)	0.67 (0.44–0.89)
	CIN 1	119	32	65	8	14	0.82 (0.75–0.89)	0.66 (0.52–0.78)
	CIN 2	21	13	4	2	2	0.81 (0.63–0.99)	0.68 (0.34–1.0)
	CIN 3	26	20	1	3	2	0.81 (0.65–97)	0.75 (0.51–0.99)
HPV 16 or 18 negative	< CIN 1	63	17	28	13	5	0.71 (0.60–0.83)	0.45 (0.22–0.68)
	CIN 1	189	70	65	40	14	0.71 (0.65–0.78)	0.43 (0.30–0.56)
	CIN 2	53	42	4	5	2	0.87 (0.78–0.96)	0.83 (0.69–0.96)
	CIN 3	28	20	1	5	2	0.75 (0.58–0.92)	0.66 (0.38–0.94)
Positive for 9 valent HPV types	< CIN 1	62	19	28	10	5	0.76 (0.65–0.87)	0.53 (0.31–0.74)
	CIN 1	184	76	65	29	14	0.77 (0.71–0.83)	0.53 (0.41–0.66))
	CIN 2	48	37	4	5	2	0.85 (0.75–0.96)	0.80 (0.65–0.96)
	CIN 3	47	35	1	9	2	0.77 (0.64–0.89)	0.69 (0.49–0.89)
Negative for 9 valent HPV types	< CIN1	42	4	28	5	5	0.76 (0.63–0.90)	0.64 (0.40–0.88)
	CIN 1	118	28	65	11	14	0.79 (0.71–0.86)	0.61 (0.47–0.76)
	CIN 2	24	16	4	2	2	0.83 (0.68–0.99)	0.73 (0.45–1.0)
	CIN 3	12	8	1	1	2	0.75 (0.48–1.0)	0.63 (0.13–1.0)

Notes: Degree of agreement categorization <0-no agreement, 0.01–0.2 slight agreement, 0.21–0.40 fair agreement, 0.41–0.60 moderate agreement, 0.61 to 0.80 substantial agreement and 0.8–1.0 almost perfect agreement.

Abbreviations: RDLA, Roche Diagnostics Linear Array; HR-HPV, high-risk human papillomavirus; CIN 1, 2, 3, cervical intraepithelial neoplasia grades.