scholarly journals Audit Of Laboratory Sensitivity Of Human Papillomavirus And Cytology Testing In A Cervical Screening Program

Author(s):  
Maria Hortlund ◽  
Laila Sara Arroyo Mühr ◽  
Camilla Lagheden ◽  
Anders Hjerpe ◽  
Joakim Dillner
2020 ◽  
Vol 26 (5) ◽  
pp. 410
Author(s):  
Sally Sweeney ◽  
Yan Cheng ◽  
Jessica R. Botfield ◽  
Deborah Bateson

From 1 December 2017, the National Cervical Screening Program was renewed in Australia, with updated national cervical screening guidelines released. This study was performed to determine clinicians’ familiarity with the updated guidelines and explore their views and attitudes towards the renewed program. Clinicians providing cervical screening in New South Wales, Australia, were invited to complete an online survey in 2018. Of the 241 clinicians who responded, 91.5% supported the change to 5-yearly human papillomavirus screening from the age of 25 years. However, nearly 13% indicated they did not know where to access the renewed guidelines and 37% had never or rarely accessed them. Open-ended responses highlighted clinicians’ concerns about missed cancers and missed opportunities for health checks. Those raising these concerns accessed the guidelines less frequently. The findings highlight important areas for additional education and support for clinicians in translating guidelines into practice to ensure successful delivery of the renewed program.


PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0247291
Author(s):  
Karin Sundström ◽  
Helena Lamin ◽  
Joakim Dillner

Evaluation of Human Papillomavirus (HPV) testing systems suitable for large-scale organized cervical screening programs is required. We evaluated the cobas 6800 HPV test system for detection of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) when nested in an organized primary HPV screening program, using the cobas 4800 test as comparator. The Karolinska University Hospital Cervical Cytology Biobank, containing frozen cervical samples from >700,000 women participating in organized cervical screening, was linked to the Swedish national cervical screening registry to identify 470 stored cervical samples taken <180 days before histopathological diagnosis of CIN3+. Two controls per case, with no abnormal results for 2 screening rounds, matched for age and sampling time were also retrieved. Aliquots from 1406 women were retrieved and re-tested on the cobas 4800 system and tested on the cobas 6800 system. There was high reproducibility between the original cobas 4800 HPV test results, and the cobas 4800 HPV re-testing performed on the samples retrieved from biobank storage. 462/464 biobanked samples from women with CIN3+ tested HPV-positive on the cobas 6800 system, corresponding to a relative sensitivity of 99.6%. 925/932 biobanked samples from control women tested HPV-negative on the cobas 6800 platform, corresponding to a relative specificity of 99.2%. By conventional criteria, the cobas 6800 was non-inferior both regarding relative sensitivity of >90% (non-inferiority p-value <0.0001) and relative specificity of >98% (non-inferiority p-value 0.006). We conclude that the cobas 6800 HPV test system had similar, high performance as the cobas 4800 such, when evaluated using cervical samples taken before CIN3+ in a real-life primary HPV screening program.


PLoS Medicine ◽  
2021 ◽  
Vol 18 (8) ◽  
pp. e1003748
Author(s):  
K. Miriam Elfström ◽  
Carina Eklund ◽  
Helena Lamin ◽  
Daniel Öhman ◽  
Maria Hortlund ◽  
...  

Background Clinical trials in the research setting have demonstrated that primary human papillomavirus (HPV)-based screening results in greater protection against cervical cancer compared with cytology, but evidence from real-life implementation was missing. To evaluate the effectiveness of HPV-based cervical screening within a real-life screening program, the organized, population-based cervical screening program in the capital region of Sweden offered either HPV- or cytology-based screening in a randomized manner through a randomized healthcare policy (RHP). Methods and findings A total of 395,725 women aged 30 to 64 years that were invited for their routine cervical screening visit were randomized without blinding to either cytology-based screening with HPV triage (n = 183,309) or HPV-based screening, with cytology triage (n = 212,416 women) between September 1, 2014 and September 30, 2016 and follow-up through June 30, 2017. The main outcome was non-inferior detection rate of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Secondary outcomes included superiority in CIN2+ detection, screening attendance, and referral to histology. In total, 120,240 had a cervical screening sample on record in the study period in the HPV arm and 99,340 in the cytology arm and were followed for the outcomes of interest. In per-protocol (PP) analyses, the detection rate of CIN2+ was 1.03% (95% confidence interval (CI) 0.98 to 1.10) in the HPV arm and 0.93% (0.87 to 0.99) in the cytology arm (p for non-inferiority <0.0001; odds ratio (OR) 1.11 (95% CI 1.02 to 1.22)). There were 46 cervical cancers detected in the HPV arm (0.04% (0.03 to 0.06)) and 48 cancers detected in the cytology arm (0.05% (0.04 to 0.07)) (p for non-inferiority <0.0001; OR 0.79 (0.53 to 1.18)). Intention-to-screen (ITS) analyses found few differences. In the HPV arm, there was a modestly increased attendance after new invitations (68.56% (68.31 to 68.80) vs. 67.71% (67.43 to 67.98); OR 1.02 (1.00 to 1.03)) and increased rate of referral with completed biopsy (3.89% (3.79 to 4.00) vs. 3.53% (3.42 to 3.65); OR 1.10 (1.05 to 1.15)). The main limitations of this analysis are that only the baseline results are presented, and there was an imbalance in invitations between the study arms. Conclusions In this study, we observed that a real-life RHP of primary HPV-based screening was acceptable and effective when evaluated against cytology-based screening, as indicated by comparable participation, referral, and detection rates. Trial registration ClinicalTrials.gov NCT01511328


2011 ◽  
Vol 130 (5) ◽  
pp. 1128-1135 ◽  
Author(s):  
Murat Gök ◽  
Folkert J. van Kemenade ◽  
Daniëlle A.M. Heideman ◽  
Johannes Berkhof ◽  
Lawrence Rozendaal ◽  
...  

Sexual Health ◽  
2010 ◽  
Vol 7 (3) ◽  
pp. 359 ◽  
Author(s):  
Karen Canfell

Epidemiologic and economic evaluation using simulation modelling can support complex policy decisions, and is an important tool in predicting the future interaction between human papillomavirus vaccination and cervical screening. Several categories of screening program evaluation are of interest, including: (1) changes to screening considered over the short term, over which the effects of vaccination should be confined to the youngest age groups (<30 years old); (2) the medium and long-term effect of vaccination on the screening program; and (3) changes to screening in context of vaccination. This review considers some of the policy questions in each category and discusses the modelling implications, with particular focus on the Australian context.


Vaccine ◽  
2013 ◽  
Vol 31 (43) ◽  
pp. 4935-4939 ◽  
Author(s):  
Veronika Učakar ◽  
Mateja M. Jelen ◽  
Helena Faust ◽  
Mario Poljak ◽  
Joakim Dillner ◽  
...  

Sexual Health ◽  
2010 ◽  
Vol 7 (3) ◽  
pp. 328 ◽  
Author(s):  
Alison C. Budd ◽  
Christine J. Sturrock

Cytological and cancer surveillance will provide the most effective indications of short-term effects and long-term outcomes of the introduction of the human papillomavirus (HPV) vaccine in Australia. This article outlines how this surveillance is proposed to occur through the established national monitoring mechanisms of the National Cervical Screening Program in the annual Australian Institute of Health and Welfare (AIHW) publication ‘Cervical screening in Australia’. Cytological surveillance will be possible principally through cytology data provided annually by the state and territory cervical cytology registers, and it is expected that these data will provide the earliest and most comprehensive indications of effects from the HPV vaccine. Some potential issues in interpreting these data are also discussed, including the potentially confounding effects of the introduction of new National Health and Medical Research Council guidelines ‘Screening to prevent cervical cancer: guidelines for the management of asymptomatic women with screen-detected abnormalities’ some 9 months before the introduction of the vaccine. Cancer surveillance over the long term will be possible using cervical cancer incidence data reported annually for the National Cervical Screening Program in ‘Cervical screening in Australia’ using data sourced from the Australian Cancer Database. In a final discourse, the HPV vaccine and cervical screening are discussed concurrently, and the importance of continued cervical screening in the HPV vaccine era emphasised.


2016 ◽  
Vol 54 (9) ◽  
pp. 2337-2342 ◽  
Author(s):  
Kate Cuschieri ◽  
Daan Geraets ◽  
Jack Cuzick ◽  
Louise Cadman ◽  
Catherine Moore ◽  
...  

The Validation of Human Papillomavirus (HPV) Genotyping Tests (VALGENT) studies offer an opportunity to clinically validate HPV assays for use in primary screening for cervical cancer and also provide a framework for the comparison of analytical and type-specific performance. Through VALGENT, we assessed the performance of the cartridge-based Xpert HPV assay (Xpert HPV), which detects 14 high-risk (HR) types and resolves HPV16 and HPV18/45. Samples from women attending the United Kingdom cervical screening program enriched with cytologically abnormal samples were collated. All had been previously tested by a clinically validated standard comparator test (SCT), the GP5+/6+ enzyme immunoassay (EIA). The clinical sensitivity and specificity of the Xpert HPV for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) and CIN3+ relative to those of the SCT were assessed as were the inter- and intralaboratory reproducibilities according to international criteria for test validation. Type concordance for HPV16 and HPV18/45 between the Xpert HPV and the SCT was also analyzed. The Xpert HPV detected 94% of CIN2+ and 98% of CIN3+ lesions among all screened women and 90% of CIN2+ and 96% of CIN3+ lesions in women 30 years and older. The specificity for CIN1 or less (≤CIN1) was 83% (95% confidence interval [CI], 80 to 85%) in all women and 88% (95% CI, 86 to 91%) in women 30 years and older. Inter- and intralaboratory agreements for the Xpert HPV were 98% and 97%, respectively. The kappa agreements for HPV16 and HPV18/45 between the clinically validated reference test (GP5+/6+ LMNX) and the Xpert HPV were 0.92 and 0.91, respectively. The clinical performance and reproducibility of the Xpert HPV are comparable to those of well-established HPV assays and fulfill the criteria for use in primary cervical cancer screening.


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