Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples

Ejegod, Ditte Møller; Junge, Jette; Franzmann, Maria‐Benedicte; Kirschner, Benny; Bottari, Fabio; Sideri, Mario; Sandri, Maria Teresa; Bonde, Jesper

doi:10.1016/j.pvr.2016.01.003

Cited by 32 publications

(44 citation statements)

References 25 publications

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“…Our study comprises 655 cases with HPV testing with extended genotyping and concurrent cytology from both SurePath collected and ThinPrep collected samples and histologically follow up. 18,19 Our data demonstrate large variations in the risk associated with the detection of different hrHPV genotypes where HPV16, HPV18, HPV31 and HPV33/HPV58 confers the highest risk of underlying disease. At the other end of the spectrum, the combined detection of HPV56/HPV59/HPV66 is associated with low risk of disease (Fig.…”

Section: Discussionmentioning

confidence: 77%

“…Here, we present data from a European study demonstrating that risk of CIN2 and ≥CIN3 is genotype specific in a colposcopy referral population of women ≥30 years of age. Our study comprises 655 cases with HPV testing with extended genotyping and concurrent cytology from both SurePath collected and ThinPrep collected samples and histologically follow up . Our data demonstrate large variations in the risk associated with the detection of different hrHPV genotypes where HPV16, HPV18, HPV31 and HPV33/HPV58 confers the highest risk of underlying disease.…”

Section: Discussionmentioning

confidence: 89%

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Bayesian analysis of baseline risk of CIN2 and ≥CIN3 by HPV genotype in a European referral cohort

Bonde

Bottari

Parvu

et al. 2019

Intl Journal of Cancer

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Whereas HPV16 and HPV18 have been the focus in current risk‐based cervical cancer screening algorithms using HPV genotype information, mounting evidence suggests that oncogenic HPV types such as HPV31, 33, 52 and 58 pose a ≥CIN3 risk equivalent to or greater than that of HPV18, and the combined risk of HPV31 and HPV33 rivals even HPV16 in women above 30 years of age. Here, we evaluate the baseline risk of CIN2 and CIN3 by genotype in a colposcopy referral population from Denmark and Italy. In total, 655 women were enrolled upon a referral to colposcopy after a positive screening sample. All samples were HPV analyzed using Onclarity HPV assay with extended genotyping and combined with the histology outcomes, a Bayesian probability modeling was used to determine the risk per genotype assessed. The combined data for this referral population showed that the ≥CIN2 risk of HPV16 was 69.1%, HPV31 at 63.3%, HPV33/58 at 52.7%, HPV18 at 46.6% and HPV52 at 40.8%. For ≥CIN3, the risks were 44.3%, 38.5%, 36.8%, 30.9% and 16.8% for HPV16, HPV31, HPV18, HPV33/58 and HPV52, respectively, indicating that the baseline risk of disease arising from HPV16 is, not surprisingly, the highest among the oncogenic HPV genotypes. We find that the HPV genotype‐specific ≥CIN2 and ≥CIN3 risk‐patterns are so distinct that, for example, 35/39/68 and 56/59/66 should be considered only for low intensive follow‐up, thereby proposing active use of this information in triage strategies for screening HPV‐positive women.

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Section: Discussionmentioning

confidence: 77%

Section: Discussionmentioning

confidence: 89%

Bayesian analysis of baseline risk of CIN2 and ≥CIN3 by HPV genotype in a European referral cohort

Bonde

Bottari

Parvu

et al. 2019

Intl Journal of Cancer

Self Cite

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“…The availability of reliable extended HPV genotyping tests has clarified the type-specific risks associated with some genotypes whose prevalence/virulence interactions historically have been averaged or masked in the absence of genotypic information. [44][45][46][47][48] In 2015, the cumulative incidence rates (CIRs) of ≥CIN3 during a 10-year prospective cohort study of women aged 30+ in the Kaiser Permanente Northern California (KPNC) health system with NILM cytology at baseline for HPV16/18 and a pool of 11 other hrHPV genotypes were 20.7, 17.7 and 1.5, respectively. 49 More recently, 3-year CIRs were reported for a cohort of women at KPNC using more extensive genotyping.…”

Section: Discussionmentioning

confidence: 99%

Approaches to triage optimization in HPV primary screening: Extended genotyping and p16/Ki‐67 dual‐stained cytology—Retrospective insights from ATHENA

Stoler

Baker

Boyle

et al. 2019

Intl Journal of Cancer

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The objective of our study was to assess the performance of different triage strategies for high‐risk human papillomavirus (hrHPV)‐positive results utilizing either extended genotyping or a p16/Ki‐67 dual‐stained cytology (DS) approach, with or without partial genotyping. A subset of women with hrHPV infections participating in the Addressing the Need for Advanced HPV Diagnostics (ATHENA) study were analyzed to determine the number of cervical intraepithelial neoplasia grade 3 or worse (≥CIN3) cases detected, and the absolute risk for ≥CIN3 of each genotype. A clinical utility table was constructed to compare the impact of different triage strategies. In all, 2,339 women with single‐genotype hrHPV infections were identified. Among these were 171 ≥CIN3 cases. The U.S. Food and Drug Administration (FDA)‐approved algorithm (HPV16/18 positive, or 12‐other hrHPV positive and Pap positive, i.e., ≥ atypical squamous cells of undetermined significance) for primary HPV screening detected 132/171 (77.2%) ≥CIN3 cases and required 964 colposcopies (colposcopies per ≥CIN3 ratio: 7.3). An approach that uses DS instead of cytology in the FDA‐approved algorithm detected 147/171 (86.0%) ≥CIN3 cases, requiring 1,012 colposcopies (ratio: 6.9). Utilizing DS for triage of all hrHPV‐positive women identified 126/171 (73.7%) ≥CIN3 cases, requiring 640 colposcopies (ratio: 5.1). A strategy that detected HPV16/18/31/33/35+ captured 130/171 (76.0%) ≥CIN3 cases, requiring 1,025 colposcopies (ratio: 7.9). Inclusion of additional genotypes resulted in greater disease detection at the expense of higher colposcopy ratios. Substituting cytology with a DS triage approach improved disease detection and the colposcopy detection rate. Further reduction of colposcopy rates can be achieved by using DS without partial genotyping. Extended genotyping strategies can identify a comparable number of cases but requires an increased number of colposcopies.

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“…The remaining HPV types are aggregated in three groups: 33/58, 35/39/68 and 56/59/66. The specific details of the assay have been published previously [14].…”

Section: Enrollment Visit Cytology and Hpv Testingmentioning

confidence: 99%

HPV infections and cytologic abnormalities in vaccinated women 21–34 years of age: Results from the baseline phase of the Onclarity trial

Parvu

Stoler

Kodsi

et al. 2019

Gynecologic Oncology

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The impact of HPV vaccination was determined in a cervical cancer screening population from the USA-based, Onclarity Trial. • HPV and cytology testing were determined in 14,153 women, 21-34 years; and compared by vaccination status. • The prevalence of overall HPV, and genotypes 16, 18, 31, and 33/58 were significantly lower in vaccinated women. • Prevalence of ≥LSIL cytology (for any HPV result), and ≥CIN2 (only for HPV 16+ or 18+ cases), was lower in vaccinated women. • Data in this article suggest that "catch-up" vaccination provides benefit for adolescents and young adults.

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Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples

Cited by 32 publications

References 25 publications

Bayesian analysis of baseline risk of CIN2 and ≥CIN3 by HPV genotype in a European referral cohort

Bayesian analysis of baseline risk of CIN2 and ≥CIN3 by HPV genotype in a European referral cohort

Approaches to triage optimization in HPV primary screening: Extended genotyping and p16/Ki‐67 dual‐stained cytology—Retrospective insights from ATHENA

HPV infections and cytologic abnormalities in vaccinated women 21–34 years of age: Results from the baseline phase of the Onclarity trial

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Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples

Cited by 32 publications

References 25 publications

Bayesian analysis of baseline risk of CIN2 and ≥CIN3 by HPV genotype in a European referral cohort

Bayesian analysis of baseline risk of CIN2 and ≥CIN3 by HPV genotype in a European referral cohort

Approaches to triage optimization in HPV primary screening: Extended genotyping and p16/Ki‐67 dual‐stained cytology—Retrospective insights from ATHENA

HPV infections and cytologic abnormalities in vaccinated women 21–34 years of age: Results from the baseline phase of the Onclarity trial

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Product

Resources

About

HPV infections and cytologic abnormalities in vaccinated women 21–34 years of age: Results from the baseline phase of the Onclarity trial