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Cervical cancer screening at crossroads.

https://arctichealth.org/en/permalink/ahliterature257093
Source
APMIS. 2014 Aug;122(8):667-73
Publication Type
Article
Date
Aug-2014
Author
Elsebeth Lynge
Carsten Rygaard
Miguel Vazquez-Prada Baillet
Pierre-Antoine Dugué
Bente Braad Sander
Jesper Bonde
Matejka Rebolj
Author Affiliation
Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Source
APMIS. 2014 Aug;122(8):667-73
Date
Aug-2014
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Cervical Intraepithelial Neoplasia - pathology - surgery
Denmark - epidemiology
Early Detection of Cancer
Female
Humans
Mass Screening
Middle Aged
Papillomaviridae
Papillomavirus Infections - diagnosis - prevention & control
Papillomavirus Vaccines
Uterine Cervical Neoplasms - epidemiology - pathology - surgery
Vaccination
Vaginal Smears
Young Adult
Abstract
Cervical screening has been one of the most successful public health prevention programmes. For 50 years, cytology formed the basis for screening, and detected cervical intraepithelial lesions (CIN) were treated surgically to prevent progression to cancer. In a high-risk country as Denmark, screening decreased the incidence of cervical cancer from 34 to 11 per 100,000, age-standardized rate (World Standard Population). Screening is, however, also expensive; Denmark (population: 5.6 million) undertakes close to half a million tests per year, and has 6-8 CIN-treated women for each prevented cancer case. The discovery of human papillomavirus (HPV) as the cause of cervical cancer dramatically changed perspectives for disease control. Screening with HPV testing was launched around 1990, and preventive HPV vaccination was licensed in 2006. Long-term randomized controlled trials (RCT) demonstrated that HPV testing provides better protection against cervical cancer than cytology, but it requires extra repeated testing. HPV vaccination RCTs, furthermore, have proved that HPV vaccination protects against vaccine-type high-grade CIN in women vaccinated prior to sexual activity, but less so in women vaccinated later. The challenge now is therefore to find an algorithm for screening of a heterogeneous population including non-vaccinated women; women vaccinated prior to start of sexual activity; and women vaccinated later.
PubMed ID
25046198 View in PubMed
Less detail

Cervical cancer screening in the Faroe Islands.

https://arctichealth.org/en/permalink/ahliterature258623
Source
Acta Oncol. 2014 Dec 15;:1-7
Publication Type
Article
Date
Dec-15-2014
Author
Turið Hammer
Elsebeth Lynge
Gisela W Djurhuus
John E Joensen
Jóanis E Køtlum
Sæunn Ó Hansen
Bente B Sander
Ole Mogensen
Matejka Rebolj
Source
Acta Oncol. 2014 Dec 15;:1-7
Date
Dec-15-2014
Language
English
Publication Type
Article
Abstract
Background. The Faroe Islands have had nationally organised cervical cancer screening since 1995. Women aged 25-60 years are invited every third year. Participation is free of charge. Although several European overviews on cervical screening are available, none have included the Faroe Islands. Our aim was to provide the first description of cervical cancer screening, and to determine the screening history of women diagnosed with cervical cancer in the Faroe Islands. Material and methods. Screening data from 1996 to 2012 were obtained from the Diagnostic Centre at the National Hospital of the Faroe Islands. They included information on cytology and HPV testing whereas information on histology was not registered consistently. Process indicators were calculated, including coverage rate, excess smears, proportion of abnormal cytological samples, and frequency of HPV testing. Data on cervical cancer cases were obtained from the Faroese Ministry of Health Affairs. The analysis of the screening history was undertaken for cases diagnosed in 2000-2010. Results. A total of 52 457 samples were taken in 1996-2012. Coverage varied between 67% and 81% and was 71% in 2012. Excess smears decreased after 1999. At present, 7.0% of samples have abnormal cytology. Of all ASCUS samples, 76-95% were tested for HPV. A total of 58% of women diagnosed with cervical cancer did not participate in screening prior to their diagnosis, and 32% had normal cytology in the previous four years. Conclusion. Despite the difficult geographical setting, the organised cervical cancer screening programme in the Faroe Islands has achieved a relatively high coverage rate. Nevertheless, challenges, e.g. consistent histology registration and sending reminders, still exist.
PubMed ID
25495570 View in PubMed
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Cervical histology after routine ThinPrep or SurePath liquid-based cytology and computer-assisted reading in Denmark.

https://arctichealth.org/en/permalink/ahliterature269983
Source
Br J Cancer. 2015 Nov 3;113(9):1259-74
Publication Type
Article
Date
Nov-3-2015
Author
Matejka Rebolj
Johanne Rask
Marjolein van Ballegooijen
Benny Kirschner
Kirsten Rozemeijer
Jesper Bonde
Carsten Rygaard
Elsebeth Lynge
Source
Br J Cancer. 2015 Nov 3;113(9):1259-74
Date
Nov-3-2015
Language
English
Publication Type
Article
Keywords
Adult
Cervical Intraepithelial Neoplasia - diagnosis - pathology
Cervix Uteri - pathology
Cytodiagnosis - methods
Denmark
False Positive Reactions
Female
Humans
Middle Aged
Sensitivity and specificity
Uterine Cervical Neoplasms - diagnosis - pathology
Vaginal Smears - methods
Young Adult
Abstract
We compared the sensitivity and specificity of liquid-based cytology (LBC) and computer-assisted reading for SurePath/FocalPoint and ThinPrep with those of manually read conventional cytology in routine cervical screening in four Danish laboratories.
Using data from five nationwide registers, technological phases were identified by slide preparation, reading technique, and triage of borderline cytology. Trends in the detection of cervical intraepithelial neoplasia (CIN) were an indicator of the technology's relative sensitivity, and trends in false-positive tests an indicator of relative specificity.
At 23-29 years, SurePath/FocalPoint statistically significantly increased the detection of ?CIN3 by 85% compared with manually read conventional cytology. The 11% increase with ThinPrep was not significant. At 30-44 years, the increase with SurePath/FocalPoint was 58%; the 16% increase with ThinPrep was not significant. At 45-59 years, both technologies led to nonsignificant decreases in the detection. SurePath/FocalPoint doubled the frequency of false-positive tests at any age. With ThinPrep, these proportions remained the same at 23-29 years, but decreased by two-thirds at 45-59 years. In a fourth laboratory with continuous use of manually read conventional cytology, no such trends were seen.
The sensitivity and specificity of modern LBC and computer-assisted reading technologies may be brand- and age-dependent.
PubMed ID
26448176 View in PubMed
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Comparison of analytical and clinical performance of CLART HPV2 genotyping assay to Linear Array and Hybrid Capture 2: a split-sample study.

https://arctichealth.org/en/permalink/ahliterature269066
Source
BMC Cancer. 2015;15:216
Publication Type
Article
Date
2015
Author
Ditte Møller Ejegod
Matejka Rebolj
Jesper Bonde
Source
BMC Cancer. 2015;15:216
Date
2015
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Aged
Cervical Intraepithelial Neoplasia - diagnosis - epidemiology - etiology
DNA, Viral - genetics
Denmark
Early Detection of Cancer
Female
Follow-Up Studies
Genotype
Genotyping Techniques - methods - standards
Humans
Middle Aged
Neoplasm Staging
Papillomaviridae - genetics
Papillomavirus Infections - complications - epidemiology - virology
Reagent kits, diagnostic
Reproducibility of Results
Sensitivity and specificity
Uterine Cervical Neoplasms - diagnosis - epidemiology - etiology
Young Adult
Abstract
Human Papillomavirus (HPV) genotyping has an increasingly important role in cervical cancer screening and vaccination monitoring, however, without an internationally agreed standard reference assay. The test results from the most widely used genotyping assays are read manually and hence prone to inter-observer variability. The reading of test results on the CLART HPV2 genotyping assay is, on the other hand, automated. The aim of our study was to directly compare the detection of HPV genotypes and high-grade cervical intraepithelial neoplasia (CIN) by CLART, Linear Array (LA), and Hybrid Capture 2 (HC2) using samples stored in SurePath.
Residual material from 401 routine samples from women with abnormal cytology was tested by CLART, LA, and HC2 (ClinicalTrial.gov: NCT01671462, Ethical Committee approval: H-2012-070). Histological outcomes were ascertained by linkage to the Danish nation-wide Pathology Data Bank. For comparison of CLART and LA in terms of genotype detection, we calculated ?-coefficients, and proportions of overall and positive agreement. For comparison of CIN detection between CLART, LA, and HC2, we calculated the relative sensitivity and specificity for high-grade CIN.
The ?-coefficient for agreement in detection of genotypes 16, 18, 31, 33, 35, and 51 was =0.90 (overall agreement: 98-99%, positive agreement: 84-95%). The values were slightly lower, but still in the "substantial" range for genotypes 39, 45, 52, 56, 58, 59, and several low-risk genotypes. The relative sensitivity of CLART for?=?CIN2 and?=?CIN3 was not significantly lower than that of LA and HC2, although CLART showed a higher specificity than HC2.
In Danish women with abnormal SurePath cytology, CLART and LA were highly comparable for detection of most high-risk and low-risk genotypes; and CLART's sensitivity for high-grade CIN was comparable to that of both LA and HC2.
Notes
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Cites: J Pathol. 1999 Sep;189(1):12-910451482
PubMed ID
25886410 View in PubMed
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Cross-reactivity profiles of hybrid capture II, cobas, and APTIMA human papillomavirus assays: split-sample study.

https://arctichealth.org/en/permalink/ahliterature286345
Source
BMC Cancer. 2016 Jul 20;16:510
Publication Type
Article
Date
Jul-20-2016
Author
Sarah Preisler
Matejka Rebolj
Ditte Møller Ejegod
Elsebeth Lynge
Carsten Rygaard
Jesper Bonde
Source
BMC Cancer. 2016 Jul 20;16:510
Date
Jul-20-2016
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Aged
Aged, 80 and over
Cervical Intraepithelial Neoplasia - diagnosis - virology
Cross Reactions
Cytodiagnosis - methods
Denmark
Early Detection of Cancer - methods
False Positive Reactions
Female
Genotype
Host-Pathogen Interactions
Humans
Mass Screening - methods
Middle Aged
Papillomaviridae - genetics - physiology
Papillomavirus Infections - diagnosis - virology
Reproducibility of Results
Sensitivity and specificity
Uterine Cervical Neoplasms - diagnosis - virology
Young Adult
Abstract
High-risk Human Papillomavirus (HPV) testing is replacing cytology in cervical cancer screening as it is more sensitive for preinvasive cervical lesions. However, the bottleneck of HPV testing is the many false positive test results (positive tests without cervical lesions). Here, we evaluated to what extent these can be explained by cross-reactivity, i.e. positive test results without evidence of high-risk HPV genotypes. The patterns of cross-reactivity have been thoroughly studied for hybrid capture II (HC2) but not yet for newer HPV assays although the manufacturers claimed no or limited frequency of cross-reactivity. In this independent study we evaluated the frequency of cross-reactivity for HC2, cobas, and APTIMA assays.
Consecutive routine cervical screening samples from 5022 Danish women, including 2859 from women attending primary screening, were tested with the three evaluated DNA and mRNA HPV assays. Genotyping was undertaken using CLART HPV2 assay, individually detecting 35 genotypes. The presence or absence of cervical lesions was determined with histological examinations; women with abnormal cytology were managed as per routine recommendations; those with normal cytology and positive high-risk HPV test results were invited for repeated testing in 18 months.
Cross-reactivity to low-risk genotypes was detected in 109 (2.2 %) out of 5022 samples on HC2, 62 (1.2 %) on cobas, and 35 (0.7 %) on APTIMA with only 10 of the samples cross-reacting on all 3 assays. None of the 35 genotypes was detected in 49 (1.0 %), 162 (3.2 %), and 56 (1.1 %) samples, respectively. In primary screening at age 30 to 65 years (n?=?2859), samples of 72 (25 %) out of 289 with high-risk infections on HC2 and?
Notes
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PubMed ID
27439470 View in PubMed
Less detail
Source
Scand J Public Health. 2011 Jul;39(7 Suppl):30-3
Publication Type
Article
Date
Jul-2011
Author
Elsebeth Lynge
Jakob Lynge Sandegaard
Matejka Rebolj
Author Affiliation
Institute of Public Health, University of Copenhagen, Copenhagen, Denmark. elsebeth@pubhealth.ku.dk
Source
Scand J Public Health. 2011 Jul;39(7 Suppl):30-3
Date
Jul-2011
Language
English
Publication Type
Article
Keywords
Denmark - epidemiology
General Practice - organization & administration
Health Services Administration
Health Services Research
Humans
Patient Care Management
Patients - classification
Primary Health Care - organization & administration
Registries
Abstract
The Danish National Patient Register (NPR) was established in 1977, and it is considered to be the finest of its kind internationally.
At the onset the register included information on inpatient in somatic wards. The content of the register has gradually been expanded, and since 2007 the register has included information on all patients in Danish hospitals.
Although the NPR is overall a sound data source, both the content and the definitions of single variables have changed over time. Changes in the organisation and provision of health services may affect both the type and the completeness of registrations.
The NPR is a unique data source. Researchers using the data should carefully consider potential fallacies in the data before drawing conclusions.
PubMed ID
21775347 View in PubMed
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Disagreement between human papillomavirus assays: an unexpected challenge for the choice of an assay in primary cervical screening.

https://arctichealth.org/en/permalink/ahliterature105158
Source
PLoS One. 2014;9(1):e86835
Publication Type
Article
Date
2014
Author
Matejka Rebolj
Sarah Preisler
Ditte Møller Ejegod
Carsten Rygaard
Elsebeth Lynge
Jesper Bonde
Author Affiliation
Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Source
PLoS One. 2014;9(1):e86835
Date
2014
Language
English
Publication Type
Article
Keywords
Adult
Aged
Biological Assay - methods
Denmark
Early Detection of Cancer - methods
Female
Humans
Mass Screening - methods
Middle Aged
Papillomaviridae - chemistry
Papillomavirus Infections - diagnosis
Young Adult
Abstract
We aimed to determine the disagreement in primary cervical screening between four human papillomavirus assays: Hybrid Capture 2, cobas, CLART, and APTIMA. Material from 5,064 SurePath samples of women participating in routine cervical screening in Copenhagen, Denmark, was tested with the four assays. Positive agreement between the assays was measured as the conditional probability that the results of all compared assays were positive given that at least one assay returned a positive result. Of all 5,064 samples, 1,679 (33.2%) tested positive on at least one of the assays. Among these, 41% tested positive on all four. Agreement was lower in women aged = 30 years (30%, vs. 49% at
Notes
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PubMed ID
24466262 View in PubMed
Less detail

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

https://arctichealth.org/en/permalink/ahliterature257091
Source
BMC Infect Dis. 2014;14:413
Publication Type
Article
Date
2014
Author
Jesper Bonde
Matejka Rebolj
Ditte Møller Ejegod
Sarah Preisler
Elsebeth Lynge
Carsten Rygaard
Author Affiliation
Department of Pathology, Copenhagen University Hospital, Hvidovre, Kettegård Allé 30, 2650 Hvidovre, Denmark. jesper.hansen.bonde@regionh.dk.
Source
BMC Infect Dis. 2014;14:413
Date
2014
Language
English
Publication Type
Article
Keywords
Adult
Aged
Alphapapillomavirus - classification - genetics - isolation & purification
Denmark - epidemiology
Female
Genotype
Humans
Mass Screening - methods
Middle Aged
Oligonucleotide Array Sequence Analysis - methods
Papillomavirus Infections - diagnosis - epidemiology - virology
Polymerase Chain Reaction - methods
Population Surveillance
Prevalence
Reproducibility of Results
Uterine Cervical Neoplasms - diagnosis - epidemiology - virology
Young Adult
Abstract
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.
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).
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.
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.
Notes
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Cites: PLoS One. 2013;8(3):e5976523533648
Cites: J Pathol. 1999 Sep;189(1):12-910451482
PubMed ID
25064473 View in PubMed
Less detail

Human Papillomavirus Assays and Cytology in Primary Cervical Screening of Women Aged 30 Years and Above.

https://arctichealth.org/en/permalink/ahliterature275174
Source
PLoS One. 2016;11(1):e0147326
Publication Type
Article
Date
2016
Author
Matejka Rebolj
Jesper Bonde
Sarah Preisler
Ditte Ejegod
Carsten Rygaard
Elsebeth Lynge
Source
PLoS One. 2016;11(1):e0147326
Date
2016
Language
English
Publication Type
Article
Keywords
Adult
Aged
Biological Assay - methods
Cervical Intraepithelial Neoplasia - diagnosis - epidemiology - virology
Colposcopy
Cytodiagnosis
DNA, Viral - genetics
Denmark - epidemiology
Early Detection of Cancer
Female
Humans
Middle Aged
Papillomaviridae - isolation & purification
Papillomavirus Infections - diagnosis - epidemiology - virology
Uterine Cervical Neoplasms - diagnosis - epidemiology - virology
Vaginal Smears
Abstract
In women aged = 30 years, Human Papillomavirus testing will replace cytology for primary cervical screening. We compared Hybrid Capture 2 (HC2), cobas, CLART, and APTIMA HPV assays with cytology on 2869 SurePath samples from women undergoing routine screening at 30-65 years in Copenhagen, Denmark. Women with cytological abnormalities were managed according to routine recommendations, with 92% completeness. Those with cytology-normal/HPV-positive samples (on any of the four assays) were invited for repeated cytology and HPV testing in 1.5 year, and 58% had additional testing. HPV testing detected more = CIN3 than cytology (HC2: 35, cobas, CLART: 37, APTIMA: 34, cytology: 31), although statistically the differences were not significant. Cobas and CLART detected significantly more = CIN2 than cytology (cobas, CLART: 49, cytology: 39). The proportion of women with false-positive test results (positive test results without = CIN3) varied between 3.3% with cytology and 14.9% with cobas. All HPV assays led to significantly more false-positive tests, whereas compared to HC2 cobas and CLART were associated with a significantly higher and APTIMA with a significantly lower proportion. Detection of CIN1 was particularly increased for the three DNA assays. With APTIMA combined with cytological triage, about 20% more women were referred for colposcopy than with cytology screening. With the three DNA assays, the increase was = 50%. The number of women with repeated testing was twice as high with APTIMA and almost five times as high with cobas compared to cytology. To our knowledge, Horizon was the only study set in routine practice that compared more than two HPV assays in the same women while also ascertaining the histological status of women with normal cytology/HPV-positive test results. HPV-based screening of Danish women aged 30-65 detected more high-grade CIN but decreased the screening specificity, and increased the demand for additional testing.
Notes
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PubMed ID
26789267 View in PubMed
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Human papillomavirus self-sampling for screening nonattenders: Opt-in pilot implementation with electronic communication platforms.

https://arctichealth.org/en/permalink/ahliterature282423
Source
Int J Cancer. 2017 May 15;140(10):2212-2219
Publication Type
Article
Date
May-15-2017
Author
Janni Uyen Hoa Lam
Matejka Rebolj
Ditte Møller Ejegod
Helle Pedersen
Carsten Rygaard
Elsebeth Lynge
Louise Thirstrup Thomsen
Susanne Krüger Kjaer
Jesper Bonde
Source
Int J Cancer. 2017 May 15;140(10):2212-2219
Date
May-15-2017
Language
English
Publication Type
Article
Keywords
Adult
Aged
Denmark
Diagnostic Self Evaluation
Early Detection of Cancer - methods
Female
Follow-Up Studies
Humans
Middle Aged
Neoplasm Staging
Papillomaviridae - isolation & purification
Papillomavirus Infections - diagnosis - virology
Patient Acceptance of Health Care
Pilot Projects
Prognosis
Self Care - methods
Specimen Handling
Surveys and Questionnaires
Uterine Cervical Neoplasms - diagnosis - virology
Vaginal Smears
Young Adult
Abstract
In organized cervical screening programs, typically 25% of the invited women do not attend. The Copenhagen Self-sampling Initiative (CSi) aimed to gain experiences on participation among screening nonattenders in the Capital Region of Denmark. Here, we report on the effectiveness of different communication platforms used in the pilot with suggestions for strategies prior to a full-implementation. Moreover, an innovative approach using self-sampling brushes with unique radio frequency identification chips allowed for unprecedented levels patient identification safety. Nonattenders from the capital region of Denmark were identified via the organized national invitation module. Screening history was obtained via the nationwide pathology registry. Twenty-four thousand women were invited, and as an alternative to the regular communication platforms (letter and phone), women could request a home test via a mobile-friendly webpage. Instruction material and video-animation in several languages were made available online. Chi-square test was used to test differences. Out of all invited, 31.7% requested a home test, and 20% returned it to the laboratory. In addition, 10% were screened at the physician after receiving the invitation. Stratified by screening history, long-term unscreened women were less likely to participate than intermittently screened women (28% vs. 16%, p?
PubMed ID
28195317 View in PubMed
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