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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 posa HPV neg Total Statistics
Control (<CIN2)b
 SurePath
  HPV posa 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
  1. 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