title: HPV prevalence and genotype distribution in a population-based split-sample study of well-screened women using CLART HPV2 human papillomavirus genotype microarray system.
abstract: BACKGROUND
  Human papillomavirus (HPV) genotyping assays are becoming increasingly attractive for use in mass screening, as they offer a possibility to integrate HPV screening with HPV vaccine monitoring, thereby generating a synergy between the two main modes of cervical cancer prevention. The Genomica CLART HPV2 assay is a semi-automated PCR-based microarray assay detecting 35 high-risk and low-risk HPV genotypes. However, few reports have described this assay in cervical screening. An aim of the present study, Horizon, was to assess the prevalence of high-risk HPV infections in Copenhagen, Denmark, an area with a high background risk of cervical cancer where women aged 23-65 years are targeted for organized screening.
  
  
  METHODS
  Material from 5,068 SurePath samples of women participating in routine screening and clinical follow-up of cervical abnormalities was tested using liquid based cytology, CLART HPV2 and Hybrid Capture 2 (HC2).
  
  
  RESULTS
  At least one of the 35 defined genotypes was detected by CLART in 1,896 (37%) samples. The most frequent high-risk genotypes were HPV 16 (7%), HPV 52 (5%), and HPV 31 (4%). The most frequent low-risk genotypes were HPV 53 (5%), HPV 61 (4%), and HPV 66 (3%). Among 4,793 women targeted by the screening program (23-65 years), 1,166 (24%) tested positive for one or more of the 13 high-risk genotypes. This proportion decreased from 40% at age 23-29 years to 10% at age 60-65 years. On HC2, 1,035 (20%) samples were positive for any high-risk and thus CLART showed a higher analytical sensitivity for 13 high-risk HPV genotypes than HC2, and this was found in all age-groups and in women normal cytology.
  
  
  CONCLUSIONS
  CLART performed well with a positive reproducibility for high-risk genotypes of 86%, and a negative reproducibility of 97%. This report furthermore updates the genotype distribution in Denmark prior to the inclusion of the HPV-vaccinated cohorts into the screening program, and as such represents a valuable baseline for future vaccine impact assessment.
authors: Department of Pathology, Copenhagen University Hospital, Hvidovre, Kettegård Allé 30, 2650 Hvidovre, Denmark. jesper.hansen.bonde@regionh.dk.
authors: Jesper
authors: J
authors: Bonde
authors: Matejka
authors: M
authors: Rebolj
authors: Ditte Møller
authors: DM
authors: Ejegod
authors: Sarah
authors: S
authors: Preisler
authors: Elsebeth
authors: E
authors: Lynge
authors: Carsten
authors: C
authors: Rygaard
mesh_terms: D000328:Adult; D000368:Aged; D052685:Alphapapillomavirus / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification; D003718:Denmark / Q000453:epidemiology; D005260:Female; D005838:Genotype; D006801:Humans; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D020411:Oligonucleotide Array Sequence Analysis / Q000379:methods*; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000453:epidemiology / Q000821:virology*; D016133:Polymerase Chain Reaction / Q000379:methods*; D011159:Population Surveillance; D015995:Prevalence; D015203:Reproducibility of Results; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000453:epidemiology / Q000821:virology*; D055815:Young Adult