title: Utility of the Roche Cobas 4800 for detection of high-risk human papillomavirus in formalin-fixed paraffin-embedded oropharyngeal squamous cell carcinoma.
abstract: Clinical laboratories are expected to reliably identify human papilloma virus (HPV) associated oropharyngeal squamous cell carcinoma (OPSCC) for prognostic and potential therapeutic applications. In addition to surrogate p16 immunohistochemistry (IHC) testing, DNA-based HPV-specific testing strategies are widely utilized. Recognizing the efficiency of the Roche Cobas 4800 platform for testing gynecological cytology specimens for high-risk HPV, we elected to evaluate the potential utility of this platform for testing formalin-fixed paraffin-embedded (FFPE) OPSCC tissue. Using the Roche Linear Array assay for comparison, we tested twenty-eight samples (16 primary OPSCC, 2 lymph node metastases from primary OPSCC, 1 oral tongue carcinoma, 3 benign squamous papillomas, and 3 non-oropharyngeal carcinoma tissues). Excluding two invalid results, the Roche Cobas 4800 testing resulted in excellent inter-assay concordance (25/26, 96.2%) and 100% concordance for HPV-16/HPV-18 positive samples. This data suggests that the Roche Cobas 4800 platform may be a cost-effective method for testing OPSCC FFPE tissues in a clinical molecular pathology laboratory setting.
authors.affiliation: Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States.
authors.forename: Jason R
authors.initials: JR
authors.lastname: Pettus
authors.affiliation: Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States.
authors.forename: Terri L
authors.initials: TL
authors.lastname: Wilson
authors.affiliation: Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States.
authors.forename: Heather B
authors.initials: HB
authors.lastname: Steinmetz
authors.affiliation: Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States.
authors.forename: Joel A
authors.initials: JA
authors.lastname: Lefferts
authors.affiliation: Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States. Electronic address: Laura.J.Tafe@Hitchcock.org.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Tafe
mesh_terms: D014408:Biomarkers, Tumor / Q000235:genetics / Q000378:metabolism; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis* / Q000378:metabolism / Q000821:virology; D019941:Cyclin-Dependent Kinase Inhibitor p16 / Q000378:metabolism; D004279:DNA, Viral / Q000235:genetics; D005557:Formaldehyde; D054884:Host-Pathogen Interactions; D061809:Human Papillomavirus DNA Tests / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D007150:Immunohistochemistry; D009959:Oropharyngeal Neoplasms / Q000175:diagnosis* / Q000378:metabolism / Q000821:virology; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics* / Q000502:physiology; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000378:metabolism / Q000821:virology; D016612:Paraffin Embedding; D015203:Reproducibility of Results; D012307:Risk Factors; D012680:Sensitivity and Specificity; D016707:Tissue Fixation / Q000379:methods
chemical_list: D014408:Biomarkers, Tumor; D019941:Cyclin-Dependent Kinase Inhibitor p16; D004279:DNA, Viral; D005557:Formaldehyde
keywords: HPV; Head and neck cancer; Oropharyngeal carcinoma; p16