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 6 Intra-laboratory reproducibility and inter-laboratory agreement of the CLART4S assay using ThinPrep screening samples

Assessment and site	HPV status	Stockholm 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
Stockholm laboratory result 2	Hr-HPV positive	56	4	60	0.70	0.90
	Hr-HPV negative	34	397	431
	Total	90	401	491
Inter-laboratory Agreement
Edinburgh Laboratory result	Hr-HPV positive	73	10	83	0.81	0.93
	Hr-HPV negative	17	395	412
	Total	90	405	495

ISSN: 1471-2407