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

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

Abstract

Background: The novel BD OnclarityTM 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.

Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

References

    1. zur Hausen H. Papillomaviruses in the causation of human cancers-a brief historical account. Virology. 2009;384(2):260–265.
    1. 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. 2010;401(1):70–79.
    1. 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. 2009;10(4):321–322.
    1. 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. 2015;21(9):817–826.

    1. Cancer IAfRo: IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. In., vol. 100B. Lyon, France: WHO Press; 2012.

    1. 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. 2011;105(7):983–988.
    1. 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. 2012;30(Suppl 5):F88–F99.
    1. 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. 2014;122(8):667–673.
    1. Cuzick J., Cadman L., Mesher D., Austin J., Ashdown-Barr L., Ho L., Terry G., Liddle S., Wright C., Lyons D. Comparing the performance of six human papillomavirus tests in a screening population. Br. J. Cancer. 2013;108(4):908–913.
    1. 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. 2012;50(6):1867–1873.
    1. 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. 2013;208(3):184 e181. 184 e111.
    1. 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. 2012;206(1):46 e41. 46 e11.
    1. Cubie H.A., Cuschieri K. Understanding HPV tests and their appropriate applications. Cytopathology. 2013;24(5):289–308.
    1. 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. 2015;53(10):3272–3279.
    1. Ejegod D.M., Serrano I., Cuschieri K.S., Nussbaumer W.A., Vaughan L.M., Ahmad A.S., Cuzick J., Bonde J. Clinical validation of the BD Onclarity HPV assay using a non-inferior test. J. Med. Microbiol. Diagn. 2013
    1. 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. 2007;11(4):881–891.
    1. 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. 2013;170(1):45–46.
    1. 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. 2015;136(2):178–182.
    1. 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. 2010;102(19):1478–1488.
    1. 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. 2011;20(7):1398–1409.
    1. 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. 2009;101(7):475–487.
    1. 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. 2012;58(1–2):61–66.

    1. Roche Molecular System I: Linear Array HPV Genotyping Test Package Insert. 2013.

    1. 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. 2014;142(1):43–50.
    1. 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. 2011;49(8):3029–3032.
    1. 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. 2002;11(11):1394–1399.
    1. 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. 2008;46(8):2595–2604.
    1. 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. 2006;44(10):3680–3685.
    1. 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

Source: PubMed

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