Marc Arbyn

• Institute of Public Health

In this report, the clinical performance of Liferiver HarmoniaHPV and Liferiver VenusHPV was evaluated under the VALHUDES framework. Five hundred and twenty‐three women collected first‐void urine (FVU) with Colli‐Pee and vaginal samples with Evalyn Brush or Qvintip. Cervical samples were taken with the Cervex Brush by a clinician. Both vaginal and...

Of the 12 HPV genotypes classified as carcinogenic to humans (Group 1), over 95% of HPV‐positive cervical cancers are linked to eight genotypes (HPV16/18/31/33/35/45/52/58). Screening programmes may consider HPV tests incorporating only these genotypes to improve screening efficiency and reduce programmatic costs. Validation of such tests requires...

The introduction of self‐sampling in cervical cancer screening has raised the importance of HPV test validation on self‐collected samples. This study aimed to evaluate the clinical accuracy of the OncoPredict HPV Screening (SCR) assay on self‐collected vaginal and first‐void urine (FVU) samples, relative to cervical specimens, using the VALHUDES Fr...

Cervical cancer screening is a cornerstone of cervical cancer elimination. Detection of high‐risk human papillomavirus (hrHPV) is recommended as the first step in screening provided that the assay used has been adequately validated. The Sansure® Human Papillomavirus DNA Diagnostic Kit is a new assay designed to detect HPV16, HPV18 and 13 other HPV...

This study assessed the relative clinical sensitivity and specificity, as well as reproducibility, for high-risk HPV types of the Roche cobas HPV test when processed using the Roche cobas 5800 system. The results from this study demonstrate that the cobas HPV test using the cobas 5800 system fulfils the Meijer criteria for use in population-based c...

While HC2 and GP5+/6+ PCR‐EIA were pivotal in test validation of new HPV assays, they represent the first generation of comparator tests based upon technologies that are not in widespread use anymore. In the current guideline, criteria for second‐generation comparator tests are presented that include more detailed resolution of HPV genotypes. Secon...

Clinically validated human papillomavirus (HPV) assays are crucial in cervical cancer screening. In this study, we evaluated the Allplex HPV HR Detection assay (Seegene, SouthKorea) for its clinical accuracy and reproducibility according to the international criteria, using the RealTime High Risk HPV m2000 assay (Abbott, USA) as standard comparator...

Objective To assess the clinical values of extended human papillomavirus (HPV) genotyping in triage of high‐risk HPV‐positive women, focusing on the trade‐off between cervical precancer detections and colposcopy referrals. Methods A bivariate random‐effects model was used to estimate the diagnostic accuracy of primary HPV screening with following...

To meet the screening goal of WHO's 90‐70‐90 strategy aimed at eliminating cervical cancer (CC) by 2030, clinical validation of human papillomavirus (HPV) assays is essential to provide accurate and valid results through fulfilling three criteria of the international validation guidelines (IVGs). Previously, the clinical accuracy of the AmpFire® HP...

Cervical cancer (CC) was diagnosed in 3159 women in France in 2023, and 1117 died from it. Organized screening for cervical cancer is potentially very effective for participating women. However, reaching under-screened populations remains a major challenge. The present qualitative study explored women's opinions on what discourages or encourages th...

Objective To determine whether knowledge of cytology affects the colposcopist’s diagnostic accuracy in the identification of cervical intraepithelial neoplasia grade 2 and worse (≥ CIN2). Method In this cross-over study, healthcare professionals interpreted colposcopy images from 80 patient cases with known histological diagnoses. For each case, 2...

This study assessed the accuracy of high-risk human papillomavirus testing of BD Onclarity HPV (Onclarity) assay on vaginal self-collected FLOQSwab versus cervical samples to ensure similar accuracy to detect cervical intraepithelial neoplasia. Testing was performed on two automated platforms, BD Viper LT and BD COR, to evaluate the effect of machi...

Background Despite the widespread interest in meta-analysis of proportions, its rationale, certain theoretical and methodological concepts are poorly understood. The generalized linear models framework is well-established and provides a natural and optimal model for meta-analysis, network meta-analysis, and meta-regression of proportions. Nonethele...

The coronavirus disease 2019 (COVID-19) pandemic demonstrated the need for accurate diagnostic testing for the early detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although the pandemic has ended, accurate assays are still needed to monitor viral spread at national levels and beyond through population and wastewater surv...

More evidence from population-based cohort studies is required to confirm the application of methylation-based biomarkers in real-world settings. The cross-sectional and 24-month cumulative triage performance of a novel methylation assay targeting the host gene EPB41LE and HPV16/18 DNA L1/L2 regions among hrHPV-positive women was evaluated based on...

To support a strategy to eliminate cervical cancer as a public health problem, the World Health Organisation (WHO) reviewed its guidelines for screening and treatment of cervical pre-cancerous lesions in 2021. Women living with HIV have 6-times the risk of cervical cancer compared to women in the general population, and we harnessed a model platfor...

In 2020, the World Health Organization (WHO) launched a strategy to eliminate cervical cancer as a public health problem. To support the strategy, the WHO published updated cervical screening guidelines in 2021. To inform this update, we used an established modeling platform, Policy1-Cervix, to evaluate the impact of seven primary screening scenari...

Background An Organised Cervical Cancer Screening Programme (OCCSP) was started in Poland in 2006/2007. Each woman aged 25 to 59 is eligible for a free Pap test every 3 years in OCCSP. Despite implementation of the OCCSP, the age-standardised cervical cancer (CC) incidence and mortality rates in 2019 were 7.3/100 000 and 3.9/100 000 respectively an...

Background Cervical carcinogenesis is mediated by the HPV-E6 and E7 oncoproteins, considered as biomarkers usable in managing screen-positive women. Methods We conducted a systematic review and meta-analysis assessing the accuracy of HPV-E6/E7-oncoprotein tests to detect underlying cervical-precancer and cancer. We included studies reporting data...

Self-sampling may improve participation in cervical cancer secondary prevention programs by women who do not respond or respond irregularly when invited to contact a health professional for the collection of a cervical specimen. It could also help resolve access problems in areas with a low physician density. The present qualitative study examined...

Clinical validation of human papillomavirus (HPV) assays according to international criteria is prerequisite for their implementation in cervical cancer screening. OncoPredict HPV Quantitative Typing (QT) assay (Hiantis Srl, Milan, Italy) is a novel full‐genotyping multiplex real‐time PCR quantitative assay targeting E6/E7 genes, allowing individua...

Introduction/Background Cervical cancer is the fourth most common malignancy in women worldwide. Current cervical screening programmes use a primary screening test of high-risk HPV (hr-HPV) testing or cytology to identify at risk women. hrHPV testing has a high sensitivity but low specificity for high-grade CIN and Cancer. As a result, DNA methylat...

The implementation of cervical screening based on human papillomavirus (HPV) continues to progress rapidly across countries. Evidence has shown that assays detecting high‐risk human papillomavirus (hrHPV) deoxyribonucleic acid (DNA) are more effective than cytology‐based screening. Validation of new hrHPV DNA assays requires both noninferior clinic...

Background: The epidemiology of human papillomavirus (HPV) in women has been well documented. Less is known about the epidemiology of HPV in men. We aim to provide updated global and regional pooled overall, type-specific, and age-specific prevalence estimates of genital HPV infection in men. Methods: We conducted a systematic review and meta-an...

This study assessed the accuracy of hrHPV testing of BD Onclarity™ HPV (Onclarity) assay on vaginal self-collected FLOQSwab® versus cervical samples to ensure similar accuracy to detect cervical intraepithelial neoplasia. Testing was performed on two automated platforms, BD Viper™ and BD COR™, to evaluate the effect of machine and using two vaginal...

Introduction Human papillomavirus (HPV) is necessary but not sufficient for cervical cancer development. During cervical carcinogenesis, methylation levels increase across host and HPV DNA. DNA methylation has been proposed as a test to diagnose cervical intraepithelial neoplasia (CIN); we present a protocol to evaluate the accuracy of methylation...

The accuracy of hrHPV testing with the Xpert HPV assay on vaginal self-samples was compared with clinician-taken samples within the VALHUDES framework. We recruited 523 women in five Belgian colposcopy clinics, of which 483 (median age 40 years; IQR 31-49) were included in the main analysis (226 collected with Evalyn Brush and 257 with Qvintip). Ce...

Background Globally, cervical cancer is a major public health problem, with about 604,000 new cases and over 340,000 deaths in 2020. In Kenya, it is the leading cause of cancer deaths, with over 3,000 women dying in 2020 alone. Both the Kenyan cancer screening guidelines and the World Health Organization’s Global Cervical Cancer Elimination Strateg...

Background The COVID-19 pandemic highlighted the importance of diagnostic testing against curbing the spread of SARS-CoV-2. The urgent need and scale for diagnostic tools resulted in manufacturers of SARS-CoV-2 assays receiving emergency authorization that lacked robust analytical or clinical evaluation. As it is highly likely that testing for SARS...

In 2017, cervical cancer screening in the Netherlands switched from cytology to human papillomavirus (HPV) testing using the validated PCR-based cobas 4800. Women could order and subsequently received a free self-sampling kit (Evalyn Brush) at their home address instead of clinician sampling. In the laboratory, the shipped brush was placed into 20...

The WHO strategy for the elimination of cervical cancer sets 2030 targets for the scale-up of HPV vaccination, cervical screening, and pre-cancer and invasive cancer treatment. Screening and treatment of precancerous disease will be critical to reduce mortality in the short term, particularly in high HIV burden settings, due to the increased risk o...

A strategy for the elimination of cervical cancer as a public health problem, through the scale-up of human papillomavirus (HPV) vaccination, cervical screening and precancer/cancer treatment, was launched by the World Health Organisation (WHO) in November 2020. To support the strategy, WHO published updated cervical screening and treatment guideli...

We advise that only clinically validated HPV assays which have fulfilled internationally accepted performance criteria be used for primary cervical screening. Further, assays should be demonstrated to be fit for purpose in the laboratory in which they will ultimately be performed, and quality materials manuals and frameworks will be helpful in this...

Background Tracking progress and providing timely evidence is a fundamental step forward for countries to remain aligned with the targets set by WHO to eliminate cervical cancer as a public health problem (ie, to reduce the incidence of the disease below a threshold of 4 cases per 100 000 women-years). We aimed to assess the extent of global inequa...

Objectives Human papillomavirus (HPV) assays used in cervical cancer screening should be clinically validated according to international criteria. OncoPredict HPV® Screening (SCR) is a partial genotyping multiplex real-time PCR assay targeting E6/E7 genes of 13 high-risk (hr) HPVs. OncoPredict HPV® SCR (index assay) identifies HPV-16 and HPV-18 sep...

Background: We systematically reviewed the diagnostic accuracy of cervical cancer screening and triage strategies in women living with HIV (WLHIV). Methods: Cochrane Library, Embase, Global Health and Medline were searched for randomised controlled trials, prospective or cross-sectional studies published from database inception to 15 July 2022 r...

Background: Despite the widespread use of meta-analysis of proportions, its rationale, certain theoretical and methodological concepts are poorly understood.The framework of logistic regression is well-established and provides a natural and optimal model for meta-analysis, network meta-analysis, and meta-regressionof proportions. Nonetheless, class...

Background: Methylation-based biomarkers show promise in triaging hrHPV positive women, however, more evidence from population-based prospective studies is required to confirm its utility in real-world settings. Methods: 2000 women from Xinjiang, China were screened for cervical cancer in 2018 and annually followed-up until 2020. Swab samples of ba...

Background: In this study, we evaluated accuracy of HPV testing on self-samples versus clinician-taken samples through the VALHUDES protocol. VALHUDES was designed as a diagnostic test accuracy study, where women referred to colposcopy collected self-samples followed by clinician-taken cervical samples. Methods: Four hundred eighty-five women re...

Self-samples are becoming a crucial part of HPV-based cervical cancer screening programs to reach nonattendee women and increase screening coverage. Therefore, the VALHUDES framework was established to validate and evaluate HPV tests and devices on self-samples.

Background: Cervical cancer is the leading cause of cancer mortality in Kenya, with an estimated 3,200 deaths in 2020. Kenya has implemented cervical cancer interventions for more than a decade. We describe the evolution of the cervical cancer programme over the last 20 years and assess its performance. Methods: We searched the Ministry of Healt...

Background The incidence of high-risk human papillomavirus (hrHPV)-driven head and neck squamous cell carcinoma, in particular oropharyngeal cancers (OPC), is increasing in high-resource countries. Patients with HPV-induced cancer respond better to treatment and consequently have lower case-fatality rates than patients with HPV-unrelated OPC. These...

Local cervical treatment for squamous intraepithelial lesion (SIL) or cervical intraepithelial neoplasia (CIN) removes or ablates a cone-shaped or dome-shaped part of the cervix that contains abnormal cells. This Series paper introduces the 2022 terminology for cone dimensions after local conservative treatment for SIL, CIN, or early invasive cervi...

Objective We assessed the longitudinal risk of developing cervical intraepithelial neoplasia (CINs) with self-sampling human papillomavirus (HPV) tests, based on polymerase chain reaction (PCR) and signal amplification (careHPV), to explore the appropriate intervals for cervical cancer screening. Methods A prospective study was conducted in China...

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer worldwide with an increasing trend of its incidence. Alcohol consumption, smoking, and viral infections, such as the mucosal high-risk (HR) human papillomaviruses (HPVs) are major risk factors for HNSCC development. In particular, HR HPVs are mainly associated with a subs...

Background : Urine collection is a non-invasive self-sampling method offering the prospect of reaching women un(der)-screened for cervical cancer. The VALHUDES research framework was designed to address the lack of clinical accuracy data for high-risk (hr)HPV testing using urine samples. Objectives : Here, we report on the analytical and clinical...

Background The trade-off between comparative effectiveness and reproductive morbidity of different treatment methods for cervical intraepithelial neoplasia (CIN) remains unclear. We aimed to determine the risks of treatment failure and preterm birth associated with various treatment techniques. Methods In this systematic review and network meta-an...

Background Cervical cancer screening tests that identify DNA of the main causal agent, high-risk human papillomavirus (HPV) types, are more protective than cervical cytology. We systematically reviewed the literature to assess whether tests targeting high-risk HPV (hrHPV) mRNA are as accurate and effective as HPV DNA-based screening tests. Methods...

Background: We evaluated the longitudinal performance of three options: HPV16/18 genotyping (HPV16/18), cytology (LBC) and p16/Ki-67 Dual Stain cytology (DS) for the triage of Hr-HPV positive (Hr-HPV+) women within the cervical screening programme in Scotland. Methods: Data were derived from a cohort of Hr-HPV+ women (n=385) who participated in...

Objective To review the first two years of the primary human papillomavirus (HPV) cervical screening programme in an HPV vaccinated population. Design Observational study. Setting Australia. Participants 3 745 318 women with a primary HPV test between 1 December 2017 and 31 December 2019; most women aged <40 years had previously been offered vac...

Background High variability in the definition and interpretation of organized cancer screening needs to be addressed systematically. Moreover, the relevance of the current practice of categorizing screening programmes dichotomously into organized or non-organized needs to be revisited in the context of considerable heterogeneity that exists in the...

We conducted a meta‐analysis of test agreement/concordance between human papillomavirus (HPV) testing in self‐collected vs clinician‐collected samples in 26 studies (10 071 participants) updating a previous meta‐analysis on accuracy for cervical precancer. Pooled overall agreement was 88.7% (95% CI: 86.3%‐90.9%), positive agreement was 84.6% (95% C...

Background: Testing for SARS-CoV-2, together with vaccination, is one of the most vital strategies in curbing the current COVID-19 pandemic. The pandemic has led to an unprecedented need for diagnostic testing and the rapid emergence of an abundance of commercial assays on the market. Due to the nature of the pandemic and in the interest of health...

Objectives: The cervical cancer screening coverage remains moderate (60%) in France. The aim of the study is to evaluate the efficacy of two experimental invitation strategies (offer of urine or vaginal self-sampling kits) to reach under-screened populations and compare them with the current invitation strategy in rural departments (low medical den...

The clinical performance evaluation of the novel MassARRAY HPV assay (MA-HPV) was performed using Danish SurePath cervical cancer screening samples under the fourth VALGENT framework. The MA-HPV assay is a mass-array based assay, which individually detects 14 oncogenic HPV genotypes and five non-oncogenic types. The MA-HPV was validated using the V...

Self‐sampling provides a powerful means to engage women in cervical screening. In the original Papillomavirus Dumfries and Galloway study (PaVDaG), we demonstrated cross‐sectional similarity of high‐risk human papillomavirus (Hr‐HPV) testing on self‐taken vaginal vs clinician‐taken samples for the detection of cervical intraepithelial neoplasia 2 o...

Abstract Background Interventions to reach women who do not participate regularly in screening may reduce the risk of cervical cancer. Self-collection of a vaginal specimen has been shown to increase participation. The relative clinical accuracy of human papillomavirus (HPV) testing on first-void urine (with Colli-Pee) and on vaginal self-samples v...

Meta-analyses of survival studies aim to reveal the variation of an effect measure of interest over different studies and present a meaningful summary. They must address between study heterogeneity in several dimensions and eliminate spurious sources of variation. Forest plots of the usual (adjusted) hazard ratios are fraught with difficulties from...

(Abstracted from N Engl J Med 2021;385:1908–1918) In May 2018, the World Health Organization (WHO) called for the elimination of global cervical cancer as a major public health priority, with a 2-pronged approach focusing on effective vaccination against human papillomavirus (HPV) and the screening for and treatment of early cervical cancer. Cervic...

Aim The Papilloplex high-risk human papillomavirus (hrHPV) test (Genefirst, Oxford, UK) is a single tube real-time HPV test which provides multiplex detection and separate identification of 14 hrHPV types. Here, we present the clinical validation of the test in SurePath samples in comparison to a clinically validated reference test, the GP5+/6+Enzy...

Background High-risk human papillomavirus (hrHPV) types represent the aetiological agents in a major proportion of anal squamous cell carcinomas (ASCC). Several studies have suggested a prognostic relevance of HPV-related markers, particularly hrHPV DNA and p16INK4a (p16) protein expression, in patients with ASCC. However, broader evaluation of the...

BACKGROUND The incidence of high-risk human papillomavirus (hrHPV)-driven head and neck squamous cell carcinoma, in particular oropharyngeal cancers (OPC), is increasing in high-resource countries. Patients with HPV-induced cancer respond better to treatment and consequently have lower case-fatality rates than patients with HPV-unrelated OPC. These...

While the benefits of human papillomavirus (HPV) vaccination relating to cervical cancer prevention have been widely documented, recent published evidence is suggestive of an impact on adverse pregnancy outcomes (APOs) in vaccinated mothers and their infants, including a reduction in rates of preterm births and small for gestational age infants. In...

Objectives This study presents the clinical assessment of the Onclarity HPV Assay (Becton Dickinson) on the novel COR high-throughput instrument (Becton Dickinson) using the international guidelines in a routine setting. Methods Screening samples collected in BD SurePath from women aged 30 years and older were used in this validation. Noninferiori...

Nasopharyngeal swabs are considered the preferential collection method for SARS-CoV-2 diagnostics. Alternative sampling procedures that are less invasive and do not require a healthcare professional, such as saliva collection, would be more preferable. We compared saliva specimens and nasopharyngeal (NP) swabs with respect to sensitivity in detecti...

Purpose The aim of this study is to present a single department’s experience on cervical cancer cases following previous excision of cervical intraepithelial neoplasia (CIN) and to discuss potential pathogenesis. Methods Nine cervical cancer cases meeting the inclusion criteria, with available pathological and follow-up data, were considered eligi...

Background The comparative performance of saliva and nasopharyngeal samples for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by reverse transcriptase polymerase chain reaction (RT-PCR) in children remains unclear. As schools reopen around the world, there is an interest in the use of saliva samples for det...

Background The main risk factors for head and neck cancer (HNC) are tobacco and alcohol use. However, an important fraction of oropharyngeal cancer (OPC) is caused by human papillomaviruses (HPV), a subgroup with increasing incidence in several western countries. Methods As part of the HPV-AHEAD study, we assessed the role of HPV infection in 772...

Objective Urine self-sampling has gained increasing interest for cervical cancer screening. In contrast to analytical performance, little information is available regarding the clinical accuracy for high-risk Human Papillomavirus (hrHPV) testing on urine. Methods VALHUDES is a diagnostic test accuracy study comparing clinical accuracy to detect hi...

Only clinically validated human papillomavirus (HPV) tests should be used in cervical cancer screening. VALGENT provides a framework to validate new HPV tests. In the VALGENT-3 study, the clinical accuracy of the recently launched Abbott Alinity m HR HPV assay (Alinity m) to detect cervical precancerous lesions was assessed against the standard com...