title: Comparison of the performance of HPV tests in women with abnormal cytology: results of a study within the NHS cervical screening programme.
abstract: OBJECTIVE
  The use of testing for human papillomavirus (HPV) is now recognized as an efficient means of triaging women with low-grade cytological abnormalities to either immediate referral to colposcopy or return to routine recall. We aimed to determine the sensitivity and specificity of each of four newer tests for HPV relative to the Qiagen Hybrid Capture 2 (HC2) assay in order to determine whether they could be approved for use in triage in the NHS cervical screening programme.
  
  
  METHODS
  We compared the performance of each of four different HPV assays (Abbott M2000, Roche Cobas, Hologic Cervista and Gen-Probe APTIMA) with that of HC2 in order to determine the sensitivity and specificity of each test relative to HC2 for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse, using routine cytology samples reported as borderline (atypical squamous cells) or mild dyskaryosis (low-grade squamous intraepithelial lesion) from six laboratories in England. All women who were found to be HPV positive on any test were referred to colposcopy.
  
  
  RESULTS
  Between 2072 and 4217 tests were performed with each assay. All four assays were shown to have a relative sensitivity of no worse than 95% compared with HC2 when a cut-off of 2 relative light units (RLU) was used. All assays had higher relative specificity than HC2 for both borderline and mild cytology referrals (1.06-1.61).
  
  
  CONCLUSIONS
  All assays tested met the criteria required. Consequently, all have now been approved for use in HPV triage in the NHS cervical screening programme.
authors.affiliation: Centre for Cancer Prevention, Queen Mary University of London, London, UK.
authors.forename: S M
authors.initials: SM
authors.lastname: Moss
authors.affiliation: Public Health Laboratory, Manchester, UK.
authors.forename: A
authors.initials: A
authors.lastname: Bailey
authors.affiliation: Scottish HPV Reference Laboratory, Edinburgh, UK.
authors.forename: H
authors.initials: H
authors.lastname: Cubie
authors.affiliation: North Bristol NHS Trust, Bristol, UK.
authors.forename: K
authors.initials: K
authors.lastname: Denton
authors.affiliation: Public Health Laboratory, Manchester, UK.
authors.forename: A
authors.initials: A
authors.lastname: Sargent
authors.affiliation: Public Health Laboratory, Public Health England, Bristol, UK.
authors.forename: P
authors.initials: P
authors.lastname: Muir
authors.affiliation: Public Health Laboratory, Public Health England, Bristol, UK.
authors.forename: I B
authors.initials: IB
authors.lastname: Vipond
authors.affiliation: NHS Cancer Screening Programmes, Sheffield, UK.
authors.forename: R
authors.initials: R
authors.lastname: Winder
authors.affiliation: Institute of Cancer Sciences, University of Manchester, Manchester Academic Health Centre, UK.
authors.forename: H
authors.initials: H
authors.lastname: Kitchener
mesh_terms: D000328:Adult; D065309:Atypical Squamous Cells of the Cervix / Q000473:pathology; D003127:Colposcopy; D004279:DNA, Viral / Q000302:isolation & purification; D055088:Early Detection of Cancer; D004739:England; D005260:Female; D006801:Humans; D009693:Nucleic Acid Hybridization / Q000379:methods*; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000473:pathology* / Q000821:virology; D012367:RNA, Viral / Q000302:isolation & purification; D012680:Sensitivity and Specificity; D065310:Squamous Intraepithelial Lesions of the Cervix / Q000473:pathology* / Q000821:virology; D014218:Triage; D002583:Uterine Cervical Neoplasms / Q000473:pathology* / Q000821:virology; D002578:Uterine Cervical Dysplasia / Q000473:pathology* / Q000821:virology
chemical_list: D004279:DNA, Viral; D012367:RNA, Viral
keywords: Papanicolaou test; cervical cancer; human papillomavirus assay; triage