Validation of a Human Papillomavirus (HPV) DNA Cervical Screening Test That Provides Expanded HPV Typing

Journal of Clinical Microbiology
Maria DemarcoMark Schiffman

Abstract

As cervical cancer screening shifts from cytology to human papillomavirus (HPV) testing, a major question is the clinical value of identifying individual HPV types. We aimed to validate Onclarity (Becton Dickinson Diagnostics, Sparks, MD), a nine-channel HPV test recently approved by the FDA, by assessing (i) the association of Onclarity types/channels with precancer/cancer; (ii) HPV type/channel agreement between the results of Onclarity and cobas (Roche Molecular Systems, Pleasanton, CA), another FDA-approved test; and (iii) Onclarity typing for all types/channels compared to typing results from a research assay (linear array [LA]; Roche). We compared Onclarity to histopathology, cobas, and LA. We tested a stratified random sample (n = 9,701) of discarded routine clinical specimens that had tested positive by Hybrid Capture 2 (HC2; Qiagen, Germantown, MD). A subset had already been tested by cobas and LA (n = 1,965). Cervical histopathology was ascertained from electronic health records. Hierarchical Onclarity channels showed a significant linear association with histological severity. Onclarity and cobas had excellent agreement on partial typing of HPV16, HPV18, and the other 12 types as a pool (sample-weighted kappa value o...Continue Reading

References

Jul 23, 2002·Lancet·Attila T LorinczMark Schiffman
May 17, 2005·Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology·Philip E CastleAttila T Lorincz
Jun 27, 2008·Journal of Clinical Microbiology·Philip E CastleMark Schiffman
Jun 18, 2010·APMIS : Acta Pathologica, Microbiologica, Et Immunologica Scandinavica·Peter J F SnijdersChris J L M Meijer
Aug 31, 2010·American Journal of Obstetrics and Gynecology·Julia C GagePhilip E Castle
Oct 20, 2010·Expert Review of Anti-infective Therapy·Mario Poljak, Boštjan J Kocjan
Mar 19, 2011·The Journal of Infectious Diseases·Long Fu XiMark Schiffman
Mar 19, 2011·Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology·Philip E CastleRobert D Burk
May 24, 2011·Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology·Mark SchiffmanRobert D Burk
Nov 15, 2011·Journal of Clinical Microbiology·Julia C GageUNKNOWN PaP Cohort Study Group
Apr 4, 2013·Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology·Mark Schiffman, Nicolas Wentzensen
Dec 18, 2013·Vaccine·F Xavier BoschUNKNOWN ICO Monograph 'Comprehensive Control of HPV Infections and Related Diseases' Vaccine Volume 30, Supplement 5, 2012
Jun 14, 2014·American Journal of Clinical Pathology·Thomas C WrightLaurence M Vaughan
Jul 20, 2014·Journal of the National Cancer Institute·Julia C GageWalter K Kinney
Dec 3, 2014·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Wen ChenPhilip E Castle
Jun 20, 2015·Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology·Mark SchiffmanPhilip E Castle
Jul 8, 2015·Gynecologic Oncology·Mark SchiffmanNicolas Wentzensen
Aug 8, 2015·Journal of Clinical Microbiology·K CuschieriM Arbyn
Nov 3, 2015·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Marc ArbynWim Quint
Nov 27, 2015·BMC Infectious Diseases·Felipe A CastroNicolas Wentzensen
Aug 9, 2016·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Jack CuzickAnne Szarewski
Aug 11, 2016·International Journal of Cancer. Journal International Du Cancer·Mark SchiffmanNicolas Wentzensen
Jun 14, 2017·Gynecologic Oncology·Philip E CastleMark Schiffman
Jul 21, 2017·Journal of Clinical Microbiology·J U H LamJ Bonde

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Citations

Apr 4, 2020·Cancer Cytopathology·Carolann RisleyNicolas Wentzensen
Aug 8, 2020·The Tohoku Journal of Experimental Medicine·Iwao KukimotoUNKNOWN MINT Study II Group
Feb 27, 2021·Journal of Medical Virology·Hiroko KurokiToshiyuki Sasagawa

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