title: Universal human papillomavirus genotyping by the digene HPV Genotyping RH and LQ Tests.
abstract: BACKGROUND
  High-risk (hr)HPV testing plays an important role in primary cervical cancer screening. Subsequent hrHPV genotyping might contribute to better risk stratification. The majority of hrHPV tests do not include identification of individual hrHPV genotypes.
  
  
  OBJECTIVE
  The digene HPV Genotyping RH Test (strip-based) and LQ Test (xMAP-based) allow genotyping of GP5+/6+ amplimers, but their probes target a region in the L1 ORF, which is also amplified by other broad-spectrum hrHPV assays, e.g., the Roche Amplicor HPV Test (Amplicor) and the Roche Linear Array. The goal was to test whether the RH Test and LQ Test can be used as an universal hrHPV genotyping test.
  
  
  METHODS
  Self-collected cervico-vaginal specimens (n=416) from an epidemiologic study were analyzed with Amplicor. The amplimers obtained were also tested with the RH Test and LQ Test for identification of 18 HPV types, including the 13 hrHPVs targeted by Amplicor.
  
  
  RESULTS
  197 specimens were positive by Amplicor, in which the RH Test and LQ Test identified one of the 13 hrHPVs in 94.4% and 98.0%, respectively. In 219 specimens remaining negative by Amplicor, the RH Test and LQ Test, performed on the Amplicor amplification products, still detected one of the 13 hrHPVs in 3.7% and 5.5%, respectively, and include identification of HPV53, 66, and 82. Overall, the RH and LQ Tests demonstrated high concordance with Amplicor for hrHPV detection (κ=0.908 and κ=0.923, respectively).
  
  
  CONCLUSIONS
  The digene HPV Genotyping RH and LQ Tests can be directly used for amplimers generated by the Amplicor HPV Test.
authors.affiliation: DDL Diagnostic Laboratory, Fonteynenburghlaan 7, 2275 CX, Voorburg, The Netherlands. daan.geraets@ddl.nl
authors.forename: D T
authors.initials: DT
authors.lastname: Geraets
authors.forename: C H
authors.initials: CH
authors.lastname: Lenselink
authors.forename: R L M
authors.initials: RL
authors.lastname: Bekkers
authors.forename: L J
authors.initials: LJ
authors.lastname: van Doorn
authors.forename: W G V
authors.initials: WG
authors.lastname: Quint
authors.forename: W J G
authors.initials: WJ
authors.lastname: Melchers
mesh_terms: D000293:Adolescent; D000328:Adult; D019411:Clinical Laboratory Techniques; D004279:DNA, Viral / Q000235:genetics*; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D005838:Genotype; D006801:Humans; D008403:Mass Screening / Q000379:methods; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000821:virology*; D016133:Polymerase Chain Reaction; D011933:Reagent Kits, Diagnostic; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000821:virology; D014626:Vaginal Smears; D055815:Young Adult
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic