title: Clinical performance of the BD Onclarity HPV assay using an adjudicated cohort of BD SurePath liquid-based cytology specimens.
abstract: OBJECTIVE
  To compare the performance of the BD Onclarity HPV Assay (BD Diagnostics, Sparks, MD) in BD SurePath liquid-based cytology media with that of Hybrid Capture 2 (HC2, Qiagen, Germantown, MD) samples co-collected in specimen transport medium in an adjudicated patient cohort.
  
  
  METHODS
  The performance of the BD Onclarity HPV Assay using BD SurePath media was compared with that of HC2 samples co-collected in specimen transport medium using 541 archived samples from a multicenter US clinical trial with histologically adjudicated cervical biopsy specimens.
  
  
  RESULTS
  The sensitivity for cervical intraepithelial neoplasia (CIN) 2 positivity (n - 104) was 90.4% (95% confidence interval [CI], 83-95) and 93.3% (95% CI, 87-97) and specificity was 76.9% (95% CI, 73-81) and 77.8% (95% CI, 74-82) for the BD assay and HC2, respectively. Nine cases of CIN 2+ had results discordant with the high-risk HPV assay. All were found to have been correctly classified with the BD assay using a novel WAVE denaturing high-performance liquid chromatography double-stranded DNA sequencing method.
  
  
  CONCLUSIONS
  The clinical performance of The BD Onclarity HPV Assay with respect to histology end points was similar to HC2. Moreover, discordant analysis revealed improved performance of the BD assay with respect to ability to provide extended genotyping information and lack of cross-reactivity with low-risk HPV types associated with cellular abnormalities. The relative risks for CIN 3 disease for HPV 31 and HPV 33/58 (combined) were comparable to that of HPV 18 in this population, suggesting that these genotypes may warrant monitoring in future studies.
authors.affiliation: From the Department of Pathology, College of Physicians and Surgeons, Columbia University, NY;
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Wright
authors.affiliation: Department of Pathology, University of Virginia Health System, Charlottesville, VA;
authors.forename: Mark H
authors.initials: MH
authors.lastname: Stoler
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Agreda
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: Gerard H
authors.initials: GH
authors.lastname: Beitman
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: Erin C
authors.initials: EC
authors.lastname: Gutierrez
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: James M
authors.initials: JM
authors.lastname: Harris
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: Kristopher R
authors.initials: KR
authors.lastname: Koch
authors.affiliation: Transgenomic Inc, Omaha, NE.
authors.forename: Mindy
authors.initials: M
authors.lastname: Kuebler
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: William D
authors.initials: WD
authors.lastname: LaViers
authors.affiliation: Transgenomic Inc, Omaha, NE.
authors.forename: Benjamin L
authors.initials: BL
authors.lastname: Legendre
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: Sharon V
authors.initials: SV
authors.lastname: Leitch
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: Courtney E
authors.initials: CE
authors.lastname: Maus
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: Ray A
authors.initials: RA
authors.lastname: McMillian
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: William A
authors.initials: WA
authors.lastname: Nussbaumer
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: Marcus L R
authors.initials: ML
authors.lastname: Palmer
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Porter
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Richart
authors.affiliation: BD Diagnostics, Sparks, MD; and.
authors.forename: Ryan J
authors.initials: RJ
authors.lastname: Schwab
authors.affiliation: BD Diagnostics, Sparks, MD; and laurence_vaughan@bd.com.
authors.forename: Laurence M
authors.initials: LM
authors.lastname: Vaughan
mesh_terms: D000328:Adult; D002584:Cervix Uteri / Q000821:virology*; D004279:DNA, Viral / Q000032:analysis / Q000235:genetics; D005260:Female; D006801:Humans; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D011247:Pregnancy; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: BD Onclarity HPV Assay; Cervical cancer; High-risk HPV; Hybrid Capture 2 assay