Performance of the roche cobas 4800 high-risk human papillomavirus test in cytologic preparations of squamous cell carcinoma of the head and neck

Darcy A. Kerr, Martha B. Pitman, Brenda Sweeney, Ronald N. Arpin, David C. Wilbur, William C. Faquin

Research output: Contribution to journalArticlepeer-review

41 Scopus citations


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, paraffinembedded (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 (n515) of tumors were positive for HRHPV according to cobas. Corresponding histology with ISH (n530) 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.

Original languageEnglish (US)
Pages (from-to)167-174
Number of pages8
JournalCancer Cytopathology
Issue number3
StatePublished - Mar 2014
Externally publishedYes


  • Cobas
  • Cytology
  • Fine-needle aspiration
  • Head and neck
  • Human papillomavirus
  • Polymerase chain reaction
  • Squamous cell carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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