HPV Prevalence in the Dutch cervical cancer screening population (DuSC study): HPV testing using automated HC2, cobas and Aptima workflows

Abstract

BackgroundPrimary high risk (hr)HPV screening will be introduced in The Netherlands in January 2017. Our aim was to determine the hrHPV prevalence in the Dutch cervical cancer screening population (DuSC study).MethodsA total of 12,113 residual PreservCyt cervical samples from the Dutch population based cytology screening program were rendered anonymous, randomized and tested for hrHPV using 3 HPV assays on their respective automated platforms: QIAGEN’s digene® HC2 HPV DNA Test® (HC2, signal amplification), Roche Cobas® HPV test (DNA amplification) and Hologic Aptima® HPV Test (RNA amplification). To determine the agreement between results generated using the different assays, pair wise comparison of the systems was performed by determining kappa coefficients.ResultsThe selected samples were representative for the population based screening program with respect to age distribution and cytology classification.HrHPV prevalences found were: 8.5% for HC2 (n = 959), 8.1% for cobas (n = 919) and 7.5% for Aptima (n = 849), resulting in a mean hrHPV prevalence of 8.0 ± 0.5%. Although the hrHPV prevalences of the different assays are in the range of 8%, there was a significant difference in prevalence for the HC2 vs. Aptima assay (p-value = 0.007).A clear age dependency was found, with an hrHPV prevalence ranging from 18.7 ± 1.2% in women 29-33 years of age to 4.2 ± 0.2% in women 59–63 years of age. Furthermore, a correlation between hrHPV prevalence and severity of cytology was observed, ranging from 5.5 ± 0.4% in normal cytology to 95.2 ± 1.7% in severe dysplasia.Indeed, kappa coefficients of 0.77, 0.71 and 0.72 (HC2 vs cobas, cobas vs Aptima and Aptima vs HC2, respectively) indicated substantial agreement between the results generated by the different systems. However, looking at the hrHPV positive samples, only 48% of the samples tested positive with all 3 assays.ConclusionsA hrHPV prevalence of 8% was found in this unselected population based screening cohort independently of using HC2, Aptima or cobas. This prevalence is higher than the previously reported 4–5% (POBASCAM and VUSA-Screen trials). Furthermore, the complete automated hrHPV detection workflow solutions from QIAGEN, Roche, and Hologic were successfully used and will be valuable for reliably implementing high throughput hrHPV testing in cervical cancer screening.

Human papillomaviruses other than 16, 18 and 45 are the major high risk HPV genotypes amongst women with abnormal cervical smear cytology residing in Kuwait: Implications for future vaccination strategies

“…Apart from these types 58, 31, 35 and 68 are more common than type 45. Meanwhile in another study from the Netherland, although HPV 16 was the most prevalent genotype amongst women with abnormal cervical cytology, most of the cases belonged to the non‐16, 18/45 group. In that study, the Aptima assay was one of the two assays used for HPV detection and genotyping.…”

“…In a previously published study, it was seen that amongst women residing in Kuwait, with epithelial abnormalities in cervical smears cytology, the HPV type 16 is the most common genotype . Similarly in another recent large population based study from the Netherlands, HPV 16 was found to be the most common HPV genotype amongst women with cervical smear abnormalities . However, in both these studies, although HPV 16 was the most common genotype, most of the high risk HPVs belonged to genotypes other than types 16 and 18.…”

“…9 Similarly in another recent large population based study from the Netherlands, HPV 16 was found to be the most common HPV genotype amongst women with cervical smear abnormalities. 10 However, in both these studies, although HPV 16 was the most common genotype, most of the high risk HPVs belonged to genotypes other than types 16 and 18. The two initial vaccines which have been approved by the FDA, Cervarix and Gardasil targets types the high risk HPV types 16 and 18.…”

Clinical performance of the Cobas 4800 HPV test and the Aptima HPV assay in the management of women referred to colposcopy with minor cytological abnormalities

“…Recently, a number of studies have also evaluated the clinical performance of the Cobas 4800 HPV test, the Aptima HPV assay, and HC2 in population‐based primary cervical screening setting …”

“…[22][23][24] Recently, a number of studies have also evaluated the clinical performance of the Cobas 4800 HPV test, the Aptima HPV assay, and HC2 in population-based primary cervical screening setting. [25][26][27] In Ireland, the National Cervical Screening Program CervicalCheck offers cytology-based screening to all women aged 25-60 y. Since May 2015, CervicalCheck has incorporated HPV testing for the triage of women with minor abnormalities and both the Cobas 4800 HPV test and the Aptima HPV assay are being employed.…”