title: Performance of the Roche cobas 4800 high-risk human papillomavirus test in cytologic preparations of squamous cell carcinoma of the head and neck.
abstract: BACKGROUND
  Determining high-risk human papillomavirus (HR-HPV) status of head and neck squamous cell carcinoma (HNSCC) defines a tumor subset with important clinical implications. Cytologic sampling often provides the sentinel or sole diagnostic specimen. The authors assessed the performance characteristics for the Roche cobas 4800 HPV real-time polymerase chain reaction (PCR)-based system (cobas) on cytologic specimens of HNSCC compared with standard methods of in situ hybridization (ISH) for HR-HPV and immunohistochemistry (IHC) for p16 on formalin-fixed, paraffin-embedded (FFPE) tissue.
  
  
  METHODS
  Samples of HNSCC were collected by fine-needle aspiration and from surgical biopsies or resections, fixed, and processed with the cobas system. Available corresponding FFPE samples were synchronously evaluated for HR-HPV using ISH and IHC. Discrepant cases underwent additional PCR studies for adjudication.
  
  
  RESULTS
  Thirty-six samples from 33 patients were analyzed. Forty-two percent (n = 15) of tumors were positive for HR-HPV according to cobas. Corresponding histology with ISH (n = 30) was concordant in 91% of samples. Compared with the adjudication PCR standard, there were 3 false-positive cases according to cobas. Ninety-two percent (n = 12) of cases were the HPV16 subtype. The overall sensitivity for the cobas system was 100%, and the specificity was 86%.
  
  
  CONCLUSIONS
  Concordance in HNSCC HR-HPV status between cobas and ISH/IHC was > 90%, and cobas demonstrated a sensitivity of 100% and a specificity of 86%, broadening options for HR-HPV testing of fine-needle aspiration samples. Advantages for this system include subtyping of HR-HPV and the ability to discern HR-HPV status earlier in a patient's treatment course.
authors.affiliation: Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
authors.forename: Darcy A
authors.initials: DA
authors.lastname: Kerr
authors.forename: Martha B
authors.initials: MB
authors.lastname: Pitman
authors.forename: Brenda
authors.initials: B
authors.lastname: Sweeney
authors.forename: Ronald N
authors.initials: RN
authors.lastname: Arpin
authors.forename: David C
authors.initials: DC
authors.lastname: Wilbur
authors.forename: William C
authors.initials: WC
authors.lastname: Faquin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044963:Biopsy, Fine-Needle; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000473:pathology / Q000821:virology*; D003584:Cytological Techniques; D004279:DNA, Viral / Q000032:analysis / Q000235:genetics*; D005260:Female; D006258:Head and Neck Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000821:virology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000453:epidemiology; D016133:Polymerase Chain Reaction / Q000379:methods*; D012189:Retrospective Studies; D018570:Risk Assessment; D012680:Sensitivity and Specificity
chemical_list: D004279:DNA, Viral
keywords: cobas; cytology; fine-needle aspiration; head and neck; human papillomavirus; polymerase chain reaction; squamous cell carcinoma