Clinical and Analytical Performance of the BD Onclarity HPV Assay with SurePath Screening Samples from the Danish Cervical Screening Program Using the VALGENT Framework

Bonde, Jesper; Pedersen, Helle; Quint, Wim; Xu, Lan; Arbyn, Marc; Ejegod, Ditte Møller

doi:10.1128/jcm.01518-19

Cited by 26 publications

(29 citation statements)

References 30 publications

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“…The list includes but is not limited to HC2, HPV DNA Test (Qiagen), cobas 4800 HPV Test (Roche), APTIMA HPV Assay (Hologic), and BD Onclarity HPV Assay (Becton Dickinson) [ 41 ]. In Table 1 , a selection of HPV tests is presented that are used in primary HPV screening and triage testing, as well as tests used as comparator tests for validation purposes, indicating their technical characteristics, the category they are assigned to, their validation, and intended use [ 24 , 35 , 38 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 ].…”

Section: Hpv Testing: Methodologies and Implementation In Screeninmentioning

confidence: 99%

Methodologies of Primary HPV Testing Currently Applied for Cervical Cancer Screening

Chrysostomou

Kostrikis

2020

Life

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The human papillomavirus is one of the most common sexually transmitted viruses, and an infection from this virus may become persistent, leading to diseases such as cervical cancer. In the past, cytology-based methods such as the Papanicolaou (Pap) test were imperative to identify the disease at a stage where it can be treated. However, since the 1980s where the etiological association of HPV and cervical cancer was identified, new tests began emerging directed towards identifying the virus. Furthermore, as the biology of HPV along with the relationships with its host are elucidated, these tests and treatments further advance. Recently in Europe, there is a movement towards the implementation of HPV testing methodologies in national screening programs to precede cytological testing. These screening strategies are recommended by the European guidelines and the World Health Organization. This review presents the current HPV testing methodologies, their application in organized population-based cervical cancer screening programs based on the most recent European guidelines, and their implementation status in countries in Europe.

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Section: Hpv Testing: Methodologies and Implementation In Screeninmentioning

confidence: 99%

Methodologies of Primary HPV Testing Currently Applied for Cervical Cancer Screening

Chrysostomou

Kostrikis

2020

Life

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“…The BD Onclarity ™ HPV test provides results for six individual high-risk HPV genotypes (16,18,31,45, 51 and 52), with the remaining eight high-risk genotypes reported in three small groups: (33,58), (35,39,68) and (56, 59, 66). The Onclarity ™ assay fulfills requirements for HPV tests in the context of cervical cancer screening [24,25]. Negative results will be sent to the woman, her GP and the CRCDC.…”

Section: Laboratory Testing and Gynaecological Follow-upmentioning

confidence: 99%

Study Protocol: Randomised Controlled Trial Assessing the Efficacy of Strategies Involving Self-Sampling in Cervical Cancer Screening

Lefeuvre

Pauw²,

Banaszuk

et al. 2022

Int J Public Health

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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 density and low participation rate) in France.Methods: The study is a randomised controlled trial with three arms: a control arm (conventional invitation letter) and two experimental arms (mailing of a urine or vaginal self-sampling kit). The target population includes women aged 30–65 years, who had no screening test recorded since more than 4 years and who did not respond to an invitation letter within 12 months before. The primary outcome measure is the participation rate in each arm. A team of psychologists will also investigate attitudes and experiences by semi-structured/focus-group interviews with voluntary CapU4 participants and with health professionals.Result and conclusion: CapU4 will identify effective strategies to reach women not responding to current screening invitations and will generate information about acceptance of self-sampling among women and health professionals.

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“…The higher concordance between HPV assays in women with disease has previously been observed in other studies. 29,30,37 The observation is that HPV16 and HPV35 has the best concordance between the MA-HPV test and the comparator assay, whereas HPV68 has the poorest concordance. In addition, HPV68 is close to inconsequential in cervical cancer screening with respect to cancer risk despite being included on the International Agency for Research on Cancer high-risk list.…”

Section: Discussionmentioning

confidence: 99%

Clinical Performance of the Full Genotyping Agena MassARRAY HPV Assay Using SurePath Screening Samples within the VALGENT4 Framework

Pedersen

Ejegod

Quint

et al. 2022

The Journal of Molecular Diagnostics

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The clinical performance evaluation of the novel MassARRAY human papillomavirus (MA-HPV) assay was performed using Danish SurePath cervical cancer screening samples under the fourth Validation of HPV Genotyping Tests (VALGENT) framework. The MA-HPV assay is a mass arrayebased assay that individually detects 14 oncogenic HPV genotypes and five nononcogenic types. The MA-HPV assay was validated using the VALGENT4 panel, which constitutes 997 consecutive samples from a screening population in addition to 297 disease-enriched samples with abnormal cytologic findings. The clinical accuracy of the MA-HPV assay for sensitivity and specificity was assessed relative to that of the general primer 5þ/6þ PCR enzyme immunoassay (GP-EIA), by a noninferiority test. The type-specific concordance of the MA-HPV assay with the GP5þ/6þ PCR with Luminex (GP-LMNX) genotyping was assessed as well. The relative sensitivity of the MA-HPV assay for cervical intraepithelial neoplasia 2 or 3 was 1.02 (95% CI, 0.98e1.05) and 1.01 (95% CI, 0.99e1.04), respectively. The sensitivity of the MA-HPV was noninferior to that of the GP-EIA (P Z 0.0001), whereas the specificity of the MA-HPV was inferior (0.89; 95% CI, 0.85e0.91; P > 0.99). The genotype concordance between the MA-HPV and GP-LMNX was good for most oncogenic types. The MA-HPV assay is a clinical sensitive assay with a lower clinical specificity compared with the GP-EIA. The assay in its current form seems more suited to play a role in settings where specificity is of lesser importance but where high sensitivity is paramount. Q6

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Clinical and Analytical Performance of the BD Onclarity HPV Assay with SurePath Screening Samples from the Danish Cervical Screening Program Using the VALGENT Framework

Cited by 26 publications

References 30 publications

Methodologies of Primary HPV Testing Currently Applied for Cervical Cancer Screening

Methodologies of Primary HPV Testing Currently Applied for Cervical Cancer Screening

Study Protocol: Randomised Controlled Trial Assessing the Efficacy of Strategies Involving Self-Sampling in Cervical Cancer Screening

Clinical Performance of the Full Genotyping Agena MassARRAY HPV Assay Using SurePath Screening Samples within the VALGENT4 Framework

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