title: An evaluation of the Qiagen HPV sign for the detection and genotyping of cervical lesions and oropharyngeal squamous cell carcinomas.
abstract: HPV genotyping is an important tool in the epidemiology and surveillance of HPV-associated cancers and for the risk-stratification of HPV infections. HPV sign Genotyping Test (QIAGEN) is a new pyrosequencing assay for the detection and genotyping of HPV. The sensitivity and comparative performance of HPV sign was determined using a sample panel derived from histologically confirmed cervical lesions (cervical intraepithelial neoplasia 2 or worse) and oropharyngeal squamous cell carcinomas. Comparative analysis showed that 80% of cervical intraepithelial neoplasia 2+ and 81% of oropharyngeal squamous cell carcinomas were HPV-positive by HPV sign compared to 100% of the cervical intraepithelial neoplasia 2+ and 81% of oropharyngeal squamous cell carcinomas by the digene HPV Genotyping RH Test (RH), and INNO-LiPA HPV Genotyping Extra assay, respectively. Fewer genotypes were detected overall by HPV sign than via the relevant comparator assays (10 vs 21 for cervical intraepithelial neoplasia 2+; 4 vs 9 for oropharyngeal squamous cell carcinomas) and also fewer multiple infections (9 vs 28 for cervical intraepithelial neoplasia 2+; 0 vs 4 for oropharyngeal squamous cell carcinomas). HPV sign results were more compatible with the comparator assay for the oropharyngeal squamous cell carcinoma samples (100%) than for the cervical samples (73%). These results suggest that HPV sign in its current form is suited to samples that harbour multiple infection.
authors.affiliation: Scottish Human Papillomavirus Reference Laboratory, Directorate of Laboratory Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, United Kingdom. Electronic address: Chris.Ward@nhslothian.scot.nhs.uk.
authors.forename: Chris
authors.initials: C
authors.lastname: Ward
authors.affiliation: Scottish Human Papillomavirus Reference Laboratory, Directorate of Laboratory Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, United Kingdom.
authors.forename: Johanna
authors.initials: J
authors.lastname: Pedraza
authors.affiliation: Department of Mathematics and Statistics, University of Strathclyde, Livingstone Tower, 26 Richmond Street, Glasgow G1 1XH, United Kingdom.
authors.forename: Kimberley
authors.initials: K
authors.lastname: Kavanagh
authors.affiliation: Edinburgh Specialist Virology Centre, Directorate of Laboratory Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, United Kingdom.
authors.forename: Ingolfur
authors.initials: I
authors.lastname: Johannessen
authors.affiliation: Scottish Human Papillomavirus Reference Laboratory, Directorate of Laboratory Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, United Kingdom.
authors.forename: Kate
authors.initials: K
authors.lastname: Cuschieri
mesh_terms: D002294:Carcinoma, Squamous Cell / Q000821:virology*; D005260:Female; D060005:Genotyping Techniques / Q000379:methods*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009959:Oropharyngeal Neoplasms / Q000821:virology*; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000821:virology*; D014773:Virology / Q000379:methods
keywords: Cervical; Genotyping; HPV; Oropharyngeal squamous cell carcinoma; Pyrosequencing