title: Invader human papillomavirus (HPV) type 16 and 18 assays as adjuncts to HPV screening of cervical papanicolaou smears with atypical squamous cells of undetermined significance.
abstract: BACKGROUND
  High-risk (HR) human papillomavirus (HPV) testing is standard practice for triaging women who have Papanicolaou (Pap) smears with atypical squamous cells of undetermined significance (ASC-US), however, only 5% to 17% of these women have underlying cervical intraepithelial neoplasia 2 (CIN-2)/CIN-3. Recent reports have demonstrated that the presence of either HPV type 16 (HPV-16) or HPV-18 confers an elevated risk for CIN-2/CIN-3. The current study was designed to determine the prevalence of HPV-16 and HPV-18 in ASC-US Pap smears and to determine whether further typing would enhance the risk stratification of patients for CIN-2/CIN-3.
  
  
  METHODS
  One hundred seventy-eight Pap smears with ASC-US were screened retrospectively for HR HPV by using the proprietary Invader screening assay followed by typing for HPV-16 and HPV-18 by using Invader type-specific probes on 100 of the samples. Clinical follow-up results were correlated with HPV types.
  
  
  RESULTS
  Fifty-one percent of the ASC-US samples were positive for HR HPV, the majority of which (70%) harbored non-HPV-16/HPV-18 HR HPV types; 27% were associated with HPV-16, whereas only 3% contained HPV-18. The screening assay indicated that 46% of women who had Pap smears with ASC-US were in need of further HPV-16/HPV-18 typing. Testing for HPV-16 stratified women with ASC-US into 3 groups: 1) 14% of women were positive for HPV-16 and had a high risk (54%) of CIN-2/CIN-3 on follow-up biopsy, 2) 35% of women were positive for non-HPV-16 HPV types and had an intermediate risk (9%), and 3) 51% of women were negative for HPV and had a negligible risk for CIN-2/CIN-3.
  
  
  CONCLUSIONS
  The combined application of a proprietary screening assay and a type-specific HPV-16 assay demonstrated global potential for the development of tailored management protocols for women who have Pap smears with ASC-US.
authors.affiliation: Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, California 90048, USA.
authors.forename: Anna K
authors.initials: AK
authors.lastname: Wong
authors.forename: Raymond C
authors.initials: RC
authors.lastname: Chan
authors.forename: W Stephen
authors.initials: WS
authors.lastname: Nichols
authors.forename: Shikha
authors.initials: S
authors.lastname: Bose
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005500:Follow-Up Studies; D052162:Human papillomavirus 16 / Q000302:isolation & purification*; D052161:Human papillomavirus 18 / Q000302:isolation & purification*; D006801:Humans; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D009367:Neoplasm Staging; D018307:Neoplasms, Squamous Cell / Q000150:complications / Q000175:diagnosis* / Q000821:virology; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D012189:Retrospective Studies; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014626:Vaginal Smears; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000821:virology
chemical_list: D004279:DNA, Viral