title: Comparison of the clinical performance of an HPV mRNA test and an HPV DNA test in triage of atypical squamous cells of undetermined significance (ASC-US).
abstract: OBJECTIVE
  The effect of triaging women with atypical squamous cells of undetermined significance (ASC-US) with human papillomavirus (HPV) DNA testing has been well documented. New tests detecting HPV E6/E7 mRNA are emerging, claiming to be more specific for detecting high-grade disease. We evaluated the clinical performance of two HPV tests: the Linear Array HPV genotyping test (LA) detecting HPV DNA from 37 oncogenic and non-oncogenic HPV types and the Aptima HPV assay detecting E6/E7 mRNA from 14 oncogenic HPV types.
  
  
  METHODS
  We identified 369 consecutive PreservCyt samples diagnosed with ASC-US tested for HPV DNA using the LA test. The Aptima HPV test was performed on residual material in the same vial. Follow-up of 325 women was available. The gold standard used was histologically confirmed cervical intraepithelial neoplasia (CIN) grade 2+ or 3+.
  
  
  RESULTS
  LA and Aptima HPV assays were positive in 44.3% and 31.7% of the cases, respectively. The concordance was 81.2%. The two tests had identical sensitivity for detecting CIN3+ [92.6% (95% CI, 75.7-99.1)] but the Aptima HPV assay showed a significantly better specificity of 73.8% (95% CI, 68.5-78.7) versus 60.1% (95% CI, 54.3-65.7) for LA for detecting CIN3+. When using CIN2+ as the gold standard the sensitivity for LA was higher than for the Aptima HPV assay [93.8% (95% CI, 82.8-98.7) versus 87.5% (95% CI, 74.8-95.3)], but the specificity was higher for the Aptima HPV assay: 78.0% (95% CI, 72.6-82.7) versus 64.3% (95% CI, 58.3-69.9).
  
  
  CONCLUSIONS
  Both tests showed good and equal clinical sensitivities for detecting CIN3+, but the Aptima HPV assay had significantly higher specificity for detecting CIN2+ and CIN3+ in women aged 30 years or older with ASC-US.
authors.affiliation: Department of Pathology, Vejle Hospital, Kabbeltoft, Vejle, Denmark. marianne.waldstroem@slb.regionsyddanmark.dk
authors.forename: M
authors.initials: M
authors.lastname: Waldstrom
authors.forename: D
authors.initials: D
authors.lastname: Ornskov
mesh_terms: D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000473:pathology / Q000821:virology*; D016001:Confidence Intervals; D004279:DNA, Viral / Q000235:genetics*; D005260:Female; D005500:Follow-Up Studies; D061809:Human Papillomavirus DNA Tests / Q000379:methods* / Q000592:standards*; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D012333:RNA, Messenger / Q000235:genetics; D012367:RNA, Viral / Q000235:genetics*; D012680:Sensitivity and Specificity; D014218:Triage; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000821:virology*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000473:pathology / Q000821:virology
chemical_list: D004279:DNA, Viral; D012333:RNA, Messenger; D012367:RNA, Viral