Open Access Highly Accessed Research article

HPV prevalence and genotype distribution in a population-based split-sample study of well-screened women using CLART HPV2 Human Papillomavirus genotype microarray system

Jesper Bonde12*, Matejka Rebolj3, Ditte Møller Ejegod12, Sarah Preisler12, Elsebeth Lynge3 and Carsten Rygaard1

Author Affiliations

1 Department of Pathology, Copenhagen University Hospital, Hvidovre, Kettegård Allé 30, 2650 Hvidovre, Denmark

2 Clinical Research Center, Copenhagen University Hospital, Hvidovre, Kettegård Allé 30, 2650 Hvidovre, Denmark

3 Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014 Copenhagen K, Denmark

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BMC Infectious Diseases 2014, 14:413  doi:10.1186/1471-2334-14-413

Published: 26 July 2014

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.

Keywords:
Human papillomavirus; Cervical cancer; Genotyping; Screening; Assay; CLART; HC2; Vaccine monitoring