Clinical validation of full genotyping CLART® HPV4S assay on SurePath and ThinPrep collected screening samples according to the international guidelines for human papillomavirus test requirements for cervical screening

Table 5 Intra-laboratory reproducibility and inter-laboratory agreement of individual genotype findings in SurePath screening samples

Assessment and Hr-HPV type	No. of genotype findings per run or laboratory			No. negative for both runs	Kappa Value	95% Confidence Interval
Assessment and Hr-HPV type	Combined results	First run	Second run	No. negative for both runs	Kappa Value	Lower	Upper
Intra-laboratory reproducibility
16	20	21	21	518	0.95	0.88	1.00
18	3	4	3	536	0.86	0.58	1.00
31	17	20	18	519	0.89	0.79	1.00
33	4	5	5	534	0.80	0.52	1.00
35	5	5	8	532	0.77	0.51	1.00
39	12	14	15	523	0.82	0.67	0.98
45	18	19	19	520	0.95	0.87	1.00
51	7	11	8	528	0.73	0.51	0.96
52	15	15	18	522	0.91	0.80	1.00
56	12	12	12	528	1.00	1.00	1.00
58	8	9	9	530	0.89	0.73	1.00
59	9	9	11	529	0.90	0.76	1.00
66	7	7	11	529	0.77	0.56	0.99
68	1	3	1	537	0.50	−0.1	1.00
Inter-laboratory agreement
16	17	21	18	518	0.87	0.75	0.98
18	3	4	4	536	0.86	0.58	1.00
31	15	20	16	519	0.83	0.69	0.96
33	4	5	5	534	0.80	0.52	1.00
35	5	5	7	533	0.83	0.60	1.00
39	5	14	7	524	0.47	0.20	0.73
45	13	19	13	520	0.78	0.62	0.94
51	1	11	3	527	0.14	−0.11	0.38
52	9	15	9	525	0.75	0.55	0.94
56	3	12	4	527	0.37	0.07	0.67
58	5	9	5	531	0.71	0.44	0.98
59	3	9	4	530	0.46	0.12	0.80
66	3	7	5	531	0.50	0.15	0.84
68	1	3	2	536	0.40	−0.15	0.94

ISSN: 1471-2407