title: Comparison of three human papillomavirus DNA assays and one mRNA assay in women with abnormal cytology.
abstract: OBJECTIVE
  To compare the clinical characteristics of four human papillomavirus (HPV) assays: hybrid capture 2 (HC2), cobas, CLART, and APTIMA in Danish women with abnormal cytology.
  
  
  METHODS
  SurePath samples from 367 consecutive women from Copenhagen, with atypical squamous cells of undetermined significance or worse, were tested with the four assays. These women were routinely recommended for repeated testing or were referred for colposcopy. Their worst histological diagnosis in 29 months from baseline was retrieved from the Danish National Pathology Data Bank.
  
  
  RESULTS
  Of the 367 women, 16 (4%) had no follow-up, 232 (63%) had <CIN2, 35 (10%) had CIN2, 81 (22%) had CIN3, and 3 (1%) had cervical cancer. The sensitivity for ≥CIN3 was 95% (95% CI: 88-99) for HC2, 94% (95% CI: 87-98) for cobas, 93% (95% CI: 85-97) for CLART, and 87% (95% CI: 78-93) for APTIMA. In women of age above 30 years, the sensitivities were 98% (95% CI: 87-100), 93% (95% CI: 80-98), 90% (95% CI: 77-97), and 93% (95% CI: 80-98), respectively. One woman with cervical cancer tested negative on CLART and one on cobas; HC2 and APTIMA were positive in all three cancer cases. The specificity for <CIN3 was low for all assays and varied between 22% and 35%. Similar results were seen for ≥CIN2.
  
  
  CONCLUSIONS
  Small differences in clinical characteristics were found for the four HPV assays in Danish women with abnormal cytology aged ≥30 years. At younger ages, APTIMA was somewhat less sensitive for high-grade CIN than the three HPV DNA assays.
authors.affiliation: Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014 Copenhagen K, Denmark. Electronic address: matejka.rebolj@regionh.dk.
authors.forename: Matejka
authors.initials: M
authors.lastname: Rebolj
authors.affiliation: Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014 Copenhagen K, Denmark.
authors.forename: Elsebeth
authors.initials: E
authors.lastname: Lynge
authors.affiliation: Department of Pathology, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, 2650 Hvidovre, Denmark.
authors.forename: Ditte
authors.initials: D
authors.lastname: Ejegod
authors.affiliation: Department of Pathology, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, 2650 Hvidovre, Denmark; Clinical Research Center, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, 2650 Hvidovre, Denmark.
authors.forename: Sarah
authors.initials: S
authors.lastname: Preisler
authors.affiliation: Department of Pathology, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, 2650 Hvidovre, Denmark.
authors.forename: Carsten
authors.initials: C
authors.lastname: Rygaard
authors.affiliation: Department of Pathology, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, 2650 Hvidovre, Denmark; Clinical Research Center, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, 2650 Hvidovre, Denmark.
authors.forename: Jesper
authors.initials: J
authors.lastname: Bonde
mesh_terms: D000328:Adult; D002584:Cervix Uteri / Q000166:cytology* / Q000473:pathology / Q000821:virology*; D004279:DNA, Viral / Q000032:analysis* / Q000235:genetics; D055088:Early Detection of Cancer; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000821:virology*; D012333:RNA, Messenger / Q000235:genetics*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000473:pathology / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000821:virology; D014626:Vaginal Smears; D055815:Young Adult
chemical_list: D004279:DNA, Viral; D012333:RNA, Messenger
keywords: Cervical cancer; Human papillomavirus; Human papillomavirus assays; Screening; Sensitivity; Specificity