title: Digene HPV Genotyping RH Test RUO: comparative evaluation with INNO-LiPA HPV Genotyping Extra Test for detection of 18 high-risk and probable high-risk human papillomavirus genotypes.
abstract: BACKGROUND
  Standardized and validated methods for the specific detection and identification of a spectrum of high-risk (hr) HPV genotypes will be necessary if HPV genotyping gains an important role in the clinical management of HPV-related precancerous lesions and cancers.
  
  
  OBJECTIVE
  The first comparative evaluation of novel HPV genotyping Digene HPV Genotyping RH Test RUO (Qiagen, Hilden, Germany) with standard INNO-LiPA HPV Genotyping Extra CE assay (Innogenetics, Gent, Belgium).
  
  
  METHODS
  Seventy hr-HPV positive samples were tested in parallel with both genotyping assays. The results were interpreted taking into account 15 hr-HPV and 3 probable hr-HPV genotypes that can be identified by both assays (assay-common genotypes).
  
  
  RESULTS
  Concordant results (a complete match of assay-common genotypes or negative using both assays) and compatible results (at least one genotype in common) were obtained in 42 (60.0%) and 28 (40.0%) samples, respectively. No discordant results for assay-common genotypes were obtained. Of 42 samples with compatible results, the presence of at least one assay-common genotype was detected in 37 samples, while no HPV was detected in two samples by both assays and only a single low-risk HPV was detected by INNO-LiPA in three samples.
  
  
  CONCLUSIONS
  A novel Digene test is suitable for the detection of hr-HPV genotypes in clinical samples and it provides comparable results to the well established INNO-LiPA assay. Although INNO-LiPA identified significantly more samples with multiple HPV genotypes than the Digene test, the clinical benefit of such a difference is at present unclear.
authors.affiliation: Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
authors.forename: Katja
authors.initials: K
authors.lastname: Seme
authors.forename: Snjezana Zidovec
authors.initials: SZ
authors.lastname: Lepej
authors.forename: Maja M
authors.initials: MM
authors.lastname: Lunar
authors.forename: Janja
authors.initials: J
authors.lastname: Iscić-Bes
authors.forename: Ana
authors.initials: A
authors.lastname: Planinić
authors.forename: Bostjan J
authors.initials: BJ
authors.lastname: Kocjan
authors.forename: Adriana
authors.initials: A
authors.lastname: Vince
authors.forename: Mario
authors.initials: M
authors.lastname: Poljak
mesh_terms: D052685:Alphapapillomavirus / Q000145:classification / Q000235:genetics*; D002584:Cervix Uteri / Q000821:virology; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005838:Genotype; D006801:Humans; D009693:Nucleic Acid Hybridization / Q000379:methods*; D030361:Papillomavirus Infections / Q000821:virology*; D016133:Polymerase Chain Reaction; D011933:Reagent Kits, Diagnostic; D002577:Uterine Cervical Diseases / Q000821:virology*
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic