title: Hybrid capture 2 human papillomavirus DNA testing for women with atypical squamous cells of undetermined significance Papanicolaou results in SurePath and ThinPrep specimens.
abstract: BACKGROUND
  Human papillomavirus (HPV) DNA testing using Hybrid Capture 2 assay with ThinPrep Papanicolaou (Pap) collection is the only US Food and Drug Administration-approved method for the triage of women with atypical squamous cells of undetermined significance (ASCUS). Although SurePath Pap collection has been used for Hybrid Capture 2 HPV DNA testing, clinical validation of this method has been scarce.
  
  
  METHODS
  From a cervical cancer-screening program in Mississippi, we analyzed data from screenings of 8380 women with ASCUS Pap results who underwent reflex Hybrid Capture 2 HPV DNA tests during a course of 4 years. Of these, 4145 were screened with the ThinPrep collection system, and 4235 were screened with SurePath. Results of follow-up biopsies within 3 months of Pap tests were available for the ThinPrep group (229 cases) and the SurePath group (455 cases). Hybrid Capture 2 positive rates and the follow-up biopsy results from both groups were compared.
  
  
  RESULTS
  Hybrid Capture 2 detected high-risk HPV DNA in 68.8% of ThinPrep and 66.7% of SurePath-collected specimens (P = .37). Detection rates for CIN2+ and CIN3+ were also comparable between ThinPrep (21.4%, 3.1%) and SurePath (15.4%, 4.2%) using Hybrid Capture 2 (P = .06, P = .45). In ThinPrep-collected specimens, 4.4% were quantitatively insufficient for Hybrid Capture 2 testing. Significantly more equivocal Hybrid Capture 2 results were observed in SurePath (11.4%) than in ThinPrep specimens (3.2%). However, 67.4% of women with equivocal Hybrid Capture 2 results had negative 1-year Pap cytology follow-up in the SurePath group.
  
  
  CONCLUSIONS
  Hybrid Capture 2 positive rates and CIN2-3 detection rates were comparable for the SurePath and ThinPrep Pap collection systems, thus supporting the use of SurePath for Hybrid Capture 2 testing.
authors.affiliation: Department of Pathology, University of Mississippi Medical Center, Jackson, Mississippi, USA.
authors.forename: Anwer
authors.initials: A
authors.lastname: Siddiqi
authors.forename: Michael
authors.initials: M
authors.lastname: Spataro
authors.forename: Holly
authors.initials: H
authors.lastname: McIntire
authors.forename: Israh
authors.initials: I
authors.lastname: Akhtar
authors.forename: Mithra
authors.initials: M
authors.lastname: Baliga
authors.forename: Rhyne
authors.initials: R
authors.lastname: Flowers
authors.forename: E
authors.initials: E
authors.lastname: Lin
authors.forename: Ming
authors.initials: M
authors.lastname: Guo
mesh_terms: D052685:Alphapapillomavirus / Q000235:genetics*; D001706:Biopsy; D004279:DNA, Viral / Q000032:analysis*; D005260:Female; D005500:Follow-Up Studies; D016591:Histocytological Preparation Techniques; D006801:Humans; D065006:Papanicolaou Test; D030361:Papillomavirus Infections / Q000175:diagnosis*; D014626:Vaginal Smears; D014773:Virology / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000821:virology*
chemical_list: D004279:DNA, Viral