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 4 Intra-laboratory reproducibility and inter-laboratory agreement of the CLART4S assay using SurePath screening samples

Assessment and site	HPV status	Copenhagen Laboratory Result 1		Total	Kappa	Lower bound
Assessment and site	HPV status	Hr-HPV positive	Hr-HPV negative	Total	Kappa	Lower bound
Intra-laboratory Reproducibility
Copenhagen laboratory result 2	Hr-HPV positive	125	13	138	0.87	0.93
	Hr-HPV negative	14	388	402
	Total	139	401	540
Inter-laboratory Agreement
Edinburgh Laboratory result	Hr-HPV positive	88	6	94	0.69	0.87
	Hr-HPV negative	51	395	446
	Total	139	401	540

ISSN: 1471-2407