title: Evaluation of commercial HPV assays in the context of post-treatment follow-up: Scottish Test of Cure Study (STOCS-H).
abstract: OBJECTIVE
  Human papillomavirus (HPV) testing is more sensitive than cytology for detection of residual/recurrent cervical disease after lesion treatment. Several HPV test comparison studies have been performed within triage and screening populations, but data on their comparative performance in a test of cure context is lacking. This study aims to address this gap.
  
  
  METHODS
  We compared the technical and clinical performance of Abbott RealTime High risk (HR)-HPV, Genprobe Aptima PV, Hologic Cervista HPV-HR, Qiagen Hybrid Capture 2 and Roche cobas HPV in the Early Implementation phase of a 'test of cure' service within the Scottish Cervical Screening Programme.
  
  
  RESULTS
  Valid results with all five HPV Tests from 1020 first samples taken ∼6 months post-treatment showed HPV positivity ranging from 17.84% to 26.96%. There was perfect agreement in 74%, and greatest variation between assays was observed in cytologically negative samples. Clinical performance was judged on cumulative incidence of cervical intraepithelial neoplasia 2+ (CIN2+) during follow-up (mean: 13.2 months). There were 23 cases of CIN2+ of which 14 were CIN3+. All assays, including cytology, were 100% sensitive for detection of CIN3+. Of the nine cases of residual CIN2, three assays detected all, one assay missed one and one assay missed two cases. Specificity ranged from 75% to 84% according to assay.
  
  
  CONCLUSIONS
  All assays were sensitive for detection of CIN2+ at 6 months post-treatment. The range of positivity equated to a 50% increase between assays with the lowest and highest positivity rates. The relevance of HPV positivity in the absence of cytological abnormalities requires longer follow-up to determine whether additional tools for risk stratification are required.
authors.affiliation: HPV Research Group, University of Edinburgh MRC Centre for Reproductive Health, Queen's Medical Research Institute, Edinburgh, UK.
authors.forename: H A
authors.initials: HA
authors.lastname: Cubie
authors.affiliation: HPV Research Group, University of Edinburgh MRC Centre for Reproductive Health, Queen's Medical Research Institute, Edinburgh, UK.
authors.forename: M
authors.initials: M
authors.lastname: Canham
authors.affiliation: Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, Edinburgh, UK.
authors.forename: C
authors.initials: C
authors.lastname: Moore
authors.affiliation: HPV Research Group, University of Edinburgh MRC Centre for Reproductive Health, Queen's Medical Research Institute, Edinburgh, UK.
authors.forename: J
authors.initials: J
authors.lastname: Pedraza
authors.affiliation: Wellcome Trust Clinical Research Facility, University of Edinburgh, Western General Hospital, Edinburgh, UK.
authors.forename: C
authors.initials: C
authors.lastname: Graham
authors.affiliation: Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, Edinburgh, UK.
authors.forename: K
authors.initials: K
authors.lastname: Cuschieri
mesh_terms: D004279:DNA, Viral / Q000032:analysis*; D005260:Female; D061809:Human Papillomavirus DNA Tests; D006801:Humans; D015994:Incidence; D015588:Observer Variation; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000628:therapy / Q000821:virology; D011237:Predictive Value of Tests; D015995:Prevalence; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012307:Risk Factors; D012606:Scotland / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000628:therapy / Q000821:virology; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000453:epidemiology / Q000628:therapy / Q000821:virology
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: HPV; CIN; assay performance;; post-treatment follow-up