CoChat
Sign Up
Cited by 42Cervical Cancer and HPV ResearchReproductive tract infections researchWomen's cancer prevention and management

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

Open access
Ejegod, Ditte Møller, Junge, Jette, Franzmann, Maria, Kirschner, Benny, Bottari, Fabio, Sideri, Mario, Sandri, Maria-Teresa, Bonde, Jesper·2016·Papillomavirus Research
DOI 10.1016/j.pvr.2016.01.003PMC PMC5886872
Open this paper in CoChat — free accountOpen PDF

Abstract

BACKGROUND: HPV assay (Onclarity) on the BD Viper™ LT system (BD Diagnostics, Sparks, MD), detects E6/E7 DNA from 13 high-risk HPV genotypes and HPV66. We compared the analytical and clinical performance of the Onclarity Assay to that of Hybrid Capture 2 and LINEAR ARRAY using adjudicated histological outcomes from Danish women referred for colposcopy. METHODS: 276 women from Copenhagen, Denmark were referred for colposcopy with abnormal cytology and/or a positive HPV test. Two samples for HPV analysis were taken in BD SurePath™ and in the BD cervical brush diluent (CBD) media. ClinicalTrial gov. identifier: NCT01671462, Ethical Approval: H-4-2012-070. RESULTS: Histology was normal in 84 (31%) women, 70 (26%) had CIN1, 47 (17%) CIN2, and 68 (25%) had CIN3. The Onclarity assay detected 67 out of 68 (99%) ≥CIN3 and 113/115 (98%) ≥CIN2. The specificities for <CIN2 were 21%, 17%, and 22%, for HC2, Onclarity and LA, respectively. CONCLUSION: Overall, the Onclarity HPV assay performed well on SurePath LBC and CBD media, with clinical sensitivity and specificity matching those of HC2 and LA.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1016/j.pvr.2016.01.003

Cites

1 of 1 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Clinical validation of Onclarity and Anyplex has been performed in previous studies according to international guidelines.

    “Although clinical validation of Onclarity and Anyplex has been performed in previous studies according to the international guidelines for human papillomavirus DNA testing [13–17]”

    From Comparison of Seegene Anyplex II HPV28 assay with BD Onclarity HPV assay for human papillomavirus genotyping (2022) · cites this paper as [14]

    The Discussion (Comparison to the literature; page not provided) reports earlier clinical performance studies of Onclarity, and the References list prior Onclarity clinical-validation studies. This paper does not address Anyplex or establish that validation of both assays followed international guidelines. It also cautions that its own referral-population study cannot assess primary-screening performance. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • Differences in detection technologies between the assays (Onclarity targeting E6/E7 versus Anyplex targeting L1, different amplicon lengths, and Onclarity's bulk grouping versus Anyplex's individual genotyping) might affect the concordance between the assays.

    “Altogether, these differences in detection technologies might affect the concordance between the assays.”

    From Comparison of Seegene Anyplex II HPV28 assay with BD Onclarity HPV assay for human papillomavirus genotyping (2022) · cites this paper as [14]

    Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

    Experimental — accuracy not yet measured

  • Onclarity targets the E6/E7 gene of HPV, whereas Anyplex targets the L1 gene.

    “Although Onclarity targets the E6/E7 gene of HPV [14], Anyplex targets the L1 gene [36].”

    From Comparison of Seegene Anyplex II HPV28 assay with BD Onclarity HPV assay for human papillomavirus genotyping (2022) · cites this paper as [14]

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Research works printed but not linked: 26

  1. [1]zur Hausen H. Papillomaviruses in the causation of human cancers-a brief historical account Virology 384 2 2009 260 265 19135222
  2. [2]Bernard H.U. Burk R.D. Chen Z. van Doorslaer K. zur Hausen H. de Villiers E.M. Classification of papillomaviruses (PVs) based on 189 PV types and proposal of taxonomic amendments Virology 401 1 2010 70 79 20206957 PMC3400342
  3. [3]Bouvard V. Baan R. Straif K. Grosse Y. Secretan B. El Ghissassi F. Benbrahim-Tallaa L. Guha N. Freeman C. Galichet L. A review of human carcinogens--Part B: biological agents Lancet Oncol. 10 4 2009 321 322 19350698
  4. [4]Arbyn M. Snijders P.J. Meijer C.J. Berkhof J. Cuschieri K. Kocjan B.J. Poljak M. Which high-risk HPV assays fulfil criteria for use in primary cervical cancer screening? Clin. Microbiol. Infect.: Off. Publ. Eur. Soc. Clin. Microbiol. Infect. Dis. 21 9 2015 817 826 25936581
  5. [5]Cancer IAfRo: IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. In., vol. 100B. Lyon, France: WHO Press; 2012.
  6. [6]Kelly R.S. Patnick J. Kitchener H.C. Moss S.M. HPV testing as a triage for borderline or mild dyskaryosis on cervical cytology: results from the Sentinel Sites study Br. J. Cancer 105 7 2011 983 988 21897395 PMC3185942
  7. [7]Arbyn M. Ronco G. Anttila A. Meijer C.J. Poljak M. Ogilvie G. Koliopoulos G. Naucler P. Sankaranarayanan R. Peto J. Evidence regarding human papillomavirus testing in secondary prevention of cervical cancer Vaccine 30 Suppl 5 2012 F88 F99 23199969
  8. [8]Lynge E. Rygaard C. Baillet M.V. Dugue P.A. Sander B.B. Bonde J. Rebolj M. Cervical cancer screening at crossroads APMIS: Acta Pathol., Microbiol. Et. Immunol. Scand. 122 8 2014 667 673 25046198
  9. [10]Szarewski A. Mesher D. Cadman L. Austin J. Ashdown-Barr L. Ho L. Terry G. Liddle S. Young M. Stoler M. Comparison of seven tests for high-grade cervical intraepithelial neoplasia in women with abnormal smears: the Predictors 2 study J. Clin. Microbiol. 50 6 2012 1867 1873 22422852 PMC3372127
  10. [11]Cox J.T. Castle P.E. Behrens C.M. Sharma A. Wright T.C. Jr. Cuzick J. Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from the ATHENA HPV study Am. J. Obstet. Gynecol. 208 3 2013 184 e181 184 e111 23174289
  11. [12]Wright T.C. Jr. Stoler M.H. Behrens C.M. Apple R. Derion T. Wright T.L. The ATHENA human papillomavirus study: design, methods, and baseline results Am. Journal. Obstet. Gynecol. 206 1 2012 46 e41 46 e11 21944226
  12. [13]Cubie H.A. Cuschieri K. Understanding HPV tests and their appropriate applications Cytopathology 24 5 2013 289 308 23998275
  13. [14]Cuschieri K. Geraets D.T. Moore C. Quint W. Duvall E. Arbyn M. Clinical and Analytical Performance of the Onclarity HPV Assay Using the VALGENT Framework J. Clin. Microbiol. 53 10 2015 3272 3279 26246482 PMC4572536
  14. [16]Depuydt C.E. Boulet G.A. Horvath C.A. Benoy I.H. Vereecken A.J. Bogers J.J. Comparison of MY09/11 consensus PCR and type-specific PCRs in the detection of oncogenic HPV types J. Cell. Mol. Med. 11 4 2007 881 891 17760847 PMC3823264
  15. [17]Tjalma W.A. Depuydt C.E. Cervical cancer screening: which HPV test should be used-L1 or E6/E7? Eur. J. Obstet. Gynecol. Reprod. Biol. 170 1 2013 45 46 23932300
  16. [18]Huh W.K. Ault K.A. Chelmow D. Davey D.D. Goulart R.A. Garcia F.A. Kinney W.K. Massad L.S. Mayeaux E.J. Saslow D. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance Gynecol. Oncol. 136 2 2015 178 182 25579107
  17. [19]Kjaer S.K. Frederiksen K. Munk C. Iftner T. Long-term absolute risk of cervical intraepithelial neoplasia grade 3 or worse following human papillomavirus infection: role of persistence J. Natl. Cancer Inst. 102 19 2010 1478 1488 20841605 PMC2950170
  18. [20]Schiffman M. Glass A.G. Wentzensen N. Rush B.B. Castle P.E. Scott D.R. Buckland J. Sherman M.E. Rydzak G. Kirk P. A long-term prospective study of type-specific human papillomavirus infection and risk of cervical neoplasia among 20,000 women in the Portland Kaiser Cohort Study Cancer Epidemiol. Biomarkers Prev.: Publ. Am. Assoc. Cancer Res. Cosponsored Am. Soc. Prev. Oncol. 20 7 2011 1398 1409 PMC3156084 21602310
  19. [21]Wheeler C.M. Hunt W.C. Joste N.E. Key C.R. Quint W.G. Castle P.E. Human papillomavirus genotype distributions: implications for vaccination and cancer screening in the United States J. Natl. Cancer Inst. 101 7 2009 475 487 19318628 PMC2664090
  20. [22]Onyekwuluje J.M. Steinau M. Swan D.C. Unger E.R. A real-time PCR assay for HPV52 detection and viral load quantification Clin. Lab. 58 1–2 2012 61 66 22372346
  21. [24]Wright T.C. Jr. Stoler M.H. Agreda P.M. Beitman G.H. Gutierrez E.C. Harris J.M. Koch K.R. Kuebler M. LaViers W.D. Legendre B.L. Jr. Clinical performance of the BD Onclarity HPV assay using an adjudicated cohort of BD SurePath liquid-based cytology specimens Am. J. Clin. Pathol. 142 1 2014 43 50 24926084
  22. [25]Castle P.E. Gutierrez E.C. Leitch S.V. Maus C.E. McMillian R.A. Nussbaumer W.A. Vaughan L.M. Wheeler C.M. Gravitt P.E. Schiffman M. Evaluation of a new DNA test for detection of carcinogenic human papillomavirus J. Clin. Microbiol. 49 8 2011 3029 3032 21632892 PMC3147736
  23. [26]Castle P.E. Schiffman M. Burk R.D. Wacholder S. Hildesheim A. Herrero R. Bratti M.C. Sherman M.E. Lorincz A. Restricted cross-reactivity of hybrid capture 2 with nononcogenic human papillomavirus types Cancer Epidemiol. Biomarkers Prev.: Publ. Am. Assoc. Cancer Res. Cosponsored Am. Soc. Prev. Oncol. 11 11 2002 1394 1399 12433717
  24. [27]Castle P.E. Solomon D. Wheeler C.M. Gravitt P.E. Wacholder S. Schiffman M. Human papillomavirus genotype specificity of hybrid capture 2 J. Clin. Microbiol. 46 8 2008 2595 2604 18579716 PMC2519476
  25. [28]Hesselink A.T. Bulkmans N.W. Berkhof J. Lorincz A.T. Meijer C.J. Snijders P.J. Cross-sectional comparison of an automated hybrid capture 2 assay and the consensus GP5+/6+ PCR method in a population-based cervical screening program J. Clin. Microbiol. 44 10 2006 3680 3685 17021097 PMC1594747
  26. [29]Mesher D. Szarewski A. Cadman L. Austin J. Ashdown-Barr L. Ho L. Terry G. Young M. Stoler M. Bergeron C. Comparison of human papillomavirus testing strategies for triage of women referred with low-grade cytological abnormalities Eur. J Cancer 2013 23452990

Cited by

Sorted by citations

Authors
Ejegod, D. M., Junge, J., Franzmann, M., Kirschner, B., Bottari, F., Sideri, M., Sandri, M.-T., & Bonde, J.
Affiliations
  • Copenhagen University Hospital (DK)
  • European Institute of Oncology (IT)
Corresponding author
Bonde, Jesper
ORCID
Venue
Papillomavirus Research
Publisher
Elsevier BV
Published
2016-12
Volume
2
Pages
31-37
ISSN
2405-8521 (ISSN-L)
DOI
10.1016/j.pvr.2016.01.003
PMC
PMC5886872
OpenAlex
W2289646811
Cited by
42
References
1
Citations by year
2026: 3 · 2025: 4 · 2024: 5 · 2023: 5 · 2022: 4 · 2021: 2 · 2020: 3 · 2019: 9 · 2018: 6 · 2016: 1
FWCI
5.00
Type
journal article
Language
en
Open access
Licence
Locations
  • Papillomavirus Research (publishedVersion, cc-by-nc-nd)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
Gentofte Hospital
Topics
  • Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
  • Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
Keywords
HPV genotyping, cervical intraepithelial neoplasia, CIN2+ detection, Hybrid Capture 2, linear array, high-risk HPV genotypes, assay specificity, colposcopy referral, atypical cytology
MeSH terms
Adult, Aged, Uterine Cervical Dysplasia, Denmark, DNA, Viral, Female, Humans, Middle Aged, Oncogene Proteins, Viral, Sensitivity and Specificity, Molecular Diagnostic Techniques, Papillomavirus Infections, Young Adult

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review