BMC Cancer

Table 2 Genomica CLART4S findings among control screening samples without ≥CIN2 follow-up and case samples with confirmed ≥CIN2 histology collected in SurePath and ThinPrep, respectively, with MGP-PCR as comparator assay

From: 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

	MGP-PCR			Non-inferior test
CLART4S	HPV pos^a	HPV neg	Total	Statistics
Control (<CIN2)^b
SurePath
HPV pos^a	84	26	110	P = 0.008
HPV neg	22	1052	1074
Total	106	1078	1184
ThinPrep
HPV pos	69	4	73	P = 0.000
HPV neg	87	1009	1096
Total	156	1013	1169
Case (≥CIN2)^c
SurePath
Hr-HPV pos	71	4	75	P = 0.002
Hr-HPV neg	2	4	6
Total	73	8	81
ThinPrep
Hr-HPV pos	78	0	78	P = 0.013
Hr-HPV neg	2	0	2
Total	80	0	80

^aHPV positive for 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68, ^bControl population defined as women with 2 x NILM and no confirmed CIN2 histology, ^cCase group defined as women with confirmed CIN2 or more histology

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ISSN: 1471-2407

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