@article{296fdddf3ee447769f866db847152073,
title = "Onclarity Human Papillomavirus Extended Genotyping in the Management of Cervical Intraepithelial Neoplasia 2+ Lesions: Journal of Lower Genital Tract Disease",
abstract = "Objective Many methods are available today for human papillomavirus (HPV) testing; they differ for technology, targets, and information on the genotypes detected. In this study, we evaluated the performance of the Onclarity HPV assay in detection and follow-up of cervical preneoplastic lesions. Materials and Methods One hundred sixty-seven women referred to the European Institute of Oncology, Milan, for treatment of cervical lesions were enrolled. We investigated the utility of Onclarity extended genotyping HPV test in the management of cervical intraepithelial neoplasia (CIN) 2+ preneoplastic lesion. Results At baseline, the concordance was 92% (150/163) between Onclarity and Hybrid Capture 2 (HC2) and 93% (142/152) between Onclarity and linear array, respectively. At follow-up, the concordance between Onclarity and HC2 was 80%. Seven women relapsed: 6 had persistence of the same genotypes and 1 patient tested negative not only with Onclarity but also with HC2 for the presence of a low-risk genotype in the sample. Conclusions This study showed that the evaluation of the HPV genotype persistence may represent a valid option to monitor patients treated for CIN 2+ lesions, because relapses were detected only in patients with persistence of the same genotype detected at baseline. {\textcopyright} Lippincott Williams & Wilkins.",
keywords = "cervical intraepithelial neoplasia, follow-up, HPV, real-time polymerase chain reaction genotyping, adult, Article, cancer patient, cancer recurrence, controlled study, female, follow up, genotype, human, human tissue, low risk population, major clinical study, uterine cervix carcinoma in situ, classification, complication, disease management, evaluation study, genetics, genotyping technique, isolation and purification, Italy, middle aged, molecular diagnosis, Papillomaviridae, papillomavirus infection, procedures, prospective study, recurrent disease, virology, Adult, Cervical Intraepithelial Neoplasia, Disease Management, Female, Genotype, Genotyping Techniques, Humans, Middle Aged, Molecular Diagnostic Techniques, Papillomavirus Infections, Prospective Studies, Recurrence",
author = "F. Bottari and A.D. Iacobone and S. Boveri and E.P. Preti and D. Franchi and L. Mariani and M. Preti and F. Landoni and R. Passerini and M.T. Sandri",
note = "Cited By :1 Export Date: 26 February 2020 CODEN: JLGDF Correspondence Address: Bottari, F.; Division of Laboratory Medicine, European Institute of Oncology IRCCS, via Ripamonti 435, Italy; email: fabio.bottari@ieo.it Tradenames: Onclarity, Becton Dickinson Manufacturers: Becton Dickinson Funding text 1: 1Division of Laboratory Medicine, European Institute of Oncology IRCCS, Milan, Italy; 2Preventive Gynecology Unit, European Institute of Oncology IRCCS, Milan, Italy; 3Scientific Directorate, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy; 4HPV-Unit, Regina Elena National Cancer Institute, Rome, Italy; 5Department of Obstetrics and Gynecology, University of Torino, Turin, Italy; 6Gynecologic Oncology Unit, Department of Obstetrics and Gynecology, ASST-Monza, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy; and 7Clinical Analysis Laboratory, Humanitas Research Hospital, Rozzano, Milan, Italy Reprint requests to: Fabio Bottari, ScB, Division of Laboratory Medicine, European Institute of Oncology, via Ripamonti 435, 20141, Milan, Italy. E-mail: fabio.bottari@ieo.it The authors have declared they have no conflicts of interest. The funding for this study was provided by Becton Dickinson Diagnostics (BD Diagnostics, Sparks, MA) that supplied free kits for the assays. The funder had the right to read and comment upon the article, but without editorial rights, nor any role in the final interpretation of the data. The study was approved by the institutional ethical committee (European Institute of Oncology S544 study), and informed consent was obtained from all women at the entry of the study. {\textcopyright} 2018, ASCCP DOI: 10.1097/LGT.0000000000000441 References: Zur Hausen, H., Papillomaviruses in the causation of human cancers-a brief historical account (2009) Virology, 384, pp. 260-265; Kj{\ae}r, S.K., Frederiksen, K., Munk, C., Long-term absolute risk of cervical intraepithelial neoplasia grade 3 or worse following human papillomavirus infection: Role of persistence (2010) J Natl Cancer Inst, 102, pp. 1478-1488; Poljak, M., Kocjan, B.J., O{\v s}trbenk, A., Commercially available molecular tests for human papillomaviruses (HPV): 2015 update (2016) J Clin Virol, 76, pp. S3-13; Rijkaart, D.C., Berkhof, J., Rozendaal, L., Human papillomavirus testing for the detection of high-grade cervical intraepithelial neoplasia and cancer: Final results of the POBASCAMrandomised controlled trial (2012) Lancet Oncol, 13, pp. 78-88; Mariani, L., Sandri, M.T., Preti, M., HPV-testing in follow-up of patients treated for CIN2+ lesions (2016) J Cancer, 7, pp. 107-114; Paraskevaidis, E., Arbyn, M., Sotiriadis, A., The role of HPV DNAtesting in the follow-up period after treatment for CIN: A systematic review of the literature (2001) Cancer Treat Rev, 30, pp. 205-211; Castle, P.E., Sideri, M., Jeronimo, J., Risk assessment to guide the prevention of cervical cancer (2007) Am J Obstet Gynecol, 197, pp. 356e1-356e6; Wright, T.C., Jr., Stoler, M.H., Agreda, P.M., Clinical performance of the BD Onclarity HPVassay using an adjudicated cohort of BD SurePath liquid-based cytology specimens (2014) Am J Clin Pathol, 142, pp. 43-50; Bottari, F., Sideri, M., Gulmini, C., Comparison of onclarity human papillomavirus (HPV) assay with Hybrid Capture II HPV DNA Assay for detection of cervical intraepithelial neoplasia grade 2 and 3 lesions (2015) J Clin Microbiol, 53, pp. 2109-2114; Ejegod, D.M., Junge, J., Franzmann, M., Clinical and analytical performance of the BD Onclarity{\texttrademark} HPVassay for detection of CIN2+ lesions on SurePath samples (2016) Papillomavirus Res, 2, pp. 31-37; Demarco, M., Carter-Pokras, O., Hyun, N., Validation of a human papillomavirus (HPV) DNA cervical screening test that provides expanded HPV typing (2018) J ClinMicrobiol, 56. , pii: e01910-17; Kang, W.D., Oh, M.J., Kim, S.M., Significance of human papillomavirus genotyping with high-grade cervical intraepithelial neoplasia treated by a loop electrosurgical excision procedure (2010) Am J Obstet Gynecol, 203, pp. 72e1-72e6; Kocken, M., Uijterwaal, M.H., De Vries, A.L., Berkhof, J., Ket, J.C., Helmerhorst, T.J., Meijer, C.J., High-risk human papillomavirus testing versus cytology in predicting post-treatment disease in women treated for high-grade cervical disease: A systematic review and meta-analysis (2012) Gynecol Oncol, 125, pp. 500-507; S{\"o}derlund-Strand, A., Kjellberg, L., Dillner, J., Human papillomavirus type-specific persistence and recurrence after treatment for cervical dysplasia (2014) J Med Virol, 86, pp. 634-641; Bosch, F.X., Lorincz, A., Munoz, N., The causal relation between human papillomavirus and cervical cancer (2002) J Clin Pathol, 55, pp. 244-265",
year = "2019",
doi = "10.1097/LGT.0000000000000441",
language = "English",
volume = "23",
pages = "39--42",
journal = "J. Lower Genital Tract Dis.",
issn = "1089-2591",
publisher = "Lippincott Williams and Wilkins",
number = "1",
}