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human papillomavirus

  • Open Access
    Analytical and Clinical Sample Performance Characteristics of the Onclarity Assay for the Detection of Human Papillomavirus
    Virology
    Analytical and Clinical Sample Performance Characteristics of the Onclarity Assay for the Detection of Human Papillomavirus

    The objective of this study was to determine the result reproducibility and performance of the BD Onclarity human papillomavirus (HPV) assay (Onclarity) on the BD Viper LT platform using both contrived and clinical specimens. Reproducibility was assessed in BD SurePath liquid-based cytology (LBC) medium (SurePath) using contrived panels (HPV genotype 16 [HPV16] positive, HPV18 positive, or HPV45 positive) or clinical specimens (HPV16, -...

    Stephen Young, Laurence Vaughan, Karen Yanson, Karen Eckert, Aojun Li, James Harris, Aaron Ermel, James A. Williams, Mohammad Al-Ghoul, Catherine L. Cammarata, Stephanie N. Taylor, Ronald Luff, Charles K. Cooper, Barbara Van Der Pol
  • Open Access
    Evidence for Missing Positive Results for Human Papilloma Virus 45 (HPV-45) and HPV-59 with the SPF<sub>10</sub>-DEIA-LiPA<sub>25</sub> (Version 1) Platform Compared to Type-Specific Real-Time Quantitative PCR Assays and Impact on Vaccine Effectiveness Estimates
    Virology
    Evidence for Missing Positive Results for Human Papilloma Virus 45 (HPV-45) and HPV-59 with the SPF10-DEIA-LiPA25 (Version 1) Platform Compared to Type-Specific Real-Time Quantitative PCR Assays and Impact on Vaccine Effectiveness Estimates

    Human papillomavirus (HPV) epidemiological and vaccine studies require highly sensitive HPV detection systems. The widely used broad-spectrum SPF10-DEIA-LiPA25 (SPF10 method) has reduced sensitivity toward HPV-45 and -59. Therefore, anogenital samples from the PASSYON study were retrospectively analyzed with type-specific (TS) HPV-45 and -59 real-time quantitative PCR (qPCR) assays. The SPF10...

    Kahren van Eer, Suzan Leussink, Tim T. Severs, Naomi van Marm-Wattimena, Petra J. Woestenberg, Johannes A. Bogaards, Audrey J. King
  • Evaluation and Optimization of the Clinical Accuracy of Hybribio's 14 High-Risk HPV with 16/18 Genotyping Assay within the VALGENT-3 Framework
    Virology
    Evaluation and Optimization of the Clinical Accuracy of Hybribio's 14 High-Risk HPV with 16/18 Genotyping Assay within the VALGENT-3 Framework

    Hybribio’s 14 High-Risk HPV with 16/18 genotyping real-time PCR (HBRT-H14) is a human papillomavirus (HPV) assay with approval from the China Food and Drug Administration that is widely used in China. VALGENT (VALidation of HPV GENotyping Tests) is an established framework for evaluating HPV tests’ clinical performance relative to validated comparators. The aim of this study was to assess the clinical accuracy of HBRT-H14 following...

    Lan Xu, Anja Oštrbenk Valenčak, Mario Poljak, Marc Arbyn
  • Test Accuracy of Human Papillomavirus in Urine for Detection of Cervical Intraepithelial Neoplasia
    Epidemiology
    Test Accuracy of Human Papillomavirus in Urine for Detection of Cervical Intraepithelial Neoplasia

    The objective was to assess the diagnostic test accuracy of high-risk human papillomavirus (hrHPV) testing of self-collected urine and cervicovaginal samples for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+). We recruited a convenience sample of women 25 to 65 years of age who were undergoing clinically indicated colposcopy at two medical centers in North Carolina between November 2016 and January 2019....

    Eliane Rohner, Lisa Rahangdale, Busola Sanusi, Andrea K. Knittel, Laurence Vaughan, Kirsty Chesko, Brian Faherty, Samantha E. Tulenko, John W. Schmitt, LaHoma S. Romocki, Vijay Sivaraman, Julie A. E. Nelson, Jennifer S. Smith
  • Alinity m HR HPV Assay Fulfills Criteria for Human Papillomavirus Test Requirements in Cervical Cancer Screening Settings
    Virology
    Alinity m HR HPV Assay Fulfills Criteria for Human Papillomavirus Test Requirements in Cervical Cancer Screening Settings

    The Alinity m HR HPV assay (Alinity) is a novel human papillomavirus (HPV) assay that individually identifies genotypes HPV16, HPV18, and HPV45 while reporting on 11 other high-risk HPV (hrHPV) genotypes in two aggregates: HPV31/33/52/58 and HPV35/39/51/56/59/66/68. The clinical performance of Alinity for screening for cervical cancer was evaluated in population-based settings.

    Anja Oštrbenk Valenčak, Anja Šterbenc, Katja Seme, Mario Poljak
  • Clinical and Analytical Evaluation of the Anyplex II HPV HR Detection Assay within the VALGENT-3 Framework
    Virology
    Clinical and Analytical Evaluation of the Anyplex II HPV HR Detection Assay within the VALGENT-3 Framework

    In 2012, VALidation of human papillomavirus (HPV) GENotyping Tests (VALGENT) was initiated to provide a formalized and uniform study framework for comparison and validation of HPV assays with genotyping capability. In VALGENT-3, the clinical and analytical performance of Anyplex II HPV HR detection (Anyplex) was compared to that of the Hybrid Capture 2 HPV DNA test (hc2) and the cobas 4800 HPV test (cobas).

    Anja Oštrbenk, Lan Xu, Marc Arbyn, Mario Poljak
  • Open Access
    Virology
    Evaluation of the Clinical Performance of the HPV-Risk Assay Using the VALGENT-3 Panel
    N. J. Polman, A. Oštrbenk, L. Xu, P. J. F. Snijders, C. J. L. M. Meijer, M. Poljak, D. A. M. Heideman, M. Arbyn
  • Epidemiology
    Assessment of a New Lower-Cost Real-Time PCR Assay for Detection of High-Risk Human Papillomavirus: Useful for Cervical Screening in Limited-Resource Settings?
    Joel Fokom Domgue, Mark Schiffman, Nicolas H. Wentzensen, Julia C. Gage, Philip E. Castle, Tina R. Raine-Bennett, Barbara Fetterman, Thomas Lorey, Nancy E. Poitras, Brian Befano, Yi Xie, Lais S. Miachon, Michael Dean
  • Epidemiology
    Determinants of Viral Oncogene E6-E7 mRNA Overexpression in a Population-Based Large Sample of Women Infected by High-Risk Human Papillomavirus Types
    Paolo Giorgi Rossi, Simonetta Bisanzi, Elena Allia, Alessandra Mongia, Francesca Carozzi, Anna Gillio-Tos, Laura De Marco, Guglielmo Ronco, Daniela Gustinucci, Annarosa Del Mistro, Helena Frayle, Anna Iossa, Giulia Fantacci, Giampaolo Pompeo, Elena Cesarini, Simonetta Bulletti, Basilio Passamonti, Martina Rizzi, Maria Gabriella Penon, Alessandra Barca, Maria Benevolo
    and The NTCC2 Working Group
  • Open Access
    Virology
    Stability Study of Cervical Specimens Collected by Swab and Stored Dry Followed by Human Papillomavirus DNA Detection Using the cobas 4800 Test
    Chun-Qing Lin, Xi Zeng, Jian-Feng Cui, Guang-Dong Liao, Ze-Ni Wu, Qian-Qian Gao, Xun Zhang, Xiu-Zhang Yu, Wen Chen, Ming-Rong Xi, You-Lin Qiao
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