title: Developing a new diagnostic algorithm for human papilloma virus associated oropharyngeal carcinoma: an investigation of HPV DNA assays.
abstract: BACKGROUND
  Human papilloma virus (HPV) has been implicated in the development of a large proportion of oropharyngeal squamous cell carcinoma (OPSCC). Current techniques used to diagnose HPV etiology require histopathologic analysis. We aim to investigate the diagnostic accuracy of a new application non-histopathologic diagnostic tests to help assist diagnosis of HPV-related oropharyngeal tumors.
  
  
  METHODS
  Patients with OPSCC with nodal metastasis were consecutively recruited from a multidisciplinary cancer clinic. Appropriate samples were collected and analyzed. The various tests examined included COBAS® 4800, Cervista® HR and Genotyping. These tests were compared to p16 staining, which was used as the diagnostic standard. StataIC 14.2 was used to perform analysis, including sensitivity, specificity and receiver operator characteristic [ROC] curves.
  
  
  RESULTS
  The COBAS® FNA (area under ROC 0.863) and saliva (area under ROC 0.847) samples performed well in diagnosing HPV positive and negative tumors. Samples tested with Cervista® did not corroborate p16 status reliably. We were able to increase the diagnostic yield of the COBAS® FNA samples by applying the results of the saliva test to negative FNA samples which correctly identified 11 additional p16 positive tumors (area under ROC 0.915).
  
  
  CONCLUSIONS
  Surrogate testing for HPV using alternate methods is feasible and closely predicts the results of standard diagnostic methods. In the future, these could minimize invasive procedures for diagnosing HPV-related oropharyngeal cancer, but also help to diagnose and treat patients with unknown primaries.
authors.affiliation: Department of Surgery, McMaster University, Hamilton, ON, Canada. natasha.cohen87@gmail.com.
authors.forename: Natasha
authors.initials: N
authors.lastname: Cohen
authors.affiliation: Department of Surgery, St Joseph's Healthcare, Hamilton, ON, Canada.
authors.forename: Michael
authors.initials: M
authors.lastname: Gupta
authors.affiliation: Department of Radiation Therapy, Juravinski Cancer Centre, Hamilton, ON, Canada.
authors.forename: Lilian
authors.initials: L
authors.lastname: Doerwald-Munoz
authors.affiliation: Department of Microbiology, St Joseph's Healthcare, Hamilton, ON, Canada.
authors.forename: Dan
authors.initials: D
authors.lastname: Jang
authors.affiliation: Department of Surgery, St Joseph's Healthcare, Hamilton, ON, Canada.
authors.forename: James Edward Massey
authors.initials: JE
authors.lastname: Young
authors.affiliation: Department of Surgery, St Joseph's Healthcare, Hamilton, ON, Canada.
authors.forename: Stuart
authors.initials: S
authors.lastname: Archibald
authors.affiliation: Department of Surgery, St Joseph's Healthcare, Hamilton, ON, Canada.
authors.forename: Bernard
authors.initials: B
authors.lastname: Jackson
authors.affiliation: Department of Microbiology, St Joseph's Healthcare, Hamilton, ON, Canada.
authors.forename: Jenny
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Microbiology, St Joseph's Healthcare, Hamilton, ON, Canada.
authors.forename: Max
authors.initials: M
authors.lastname: Chernesky
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D044963:Biopsy, Fine-Needle; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000821:virology*; D015331:Cohort Studies; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000821:virology*; D006801:Humans; D007150:Immunohistochemistry; D008297:Male; D008875:Middle Aged; D009864:Ontario; D009959:Oropharyngeal Neoplasms / Q000473:pathology / Q000821:virology*; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D011379:Prognosis; D012372:ROC Curve; D012189:Retrospective Studies; D018570:Risk Assessment; D000077195:Squamous Cell Carcinoma of Head and Neck
chemical_list: D004279:DNA, Viral
keywords: Diagnostic algorithm; Human papilloma virus; Oropharynx; Tonsillar cancer