title: Intracellular human papillomavirus E6, E7 mRNA quantification predicts CIN 2+ in cervical biopsies better than Papanicolaou screening for women regardless of age.
abstract: BACKGROUND
  Cervical cancer screening in women younger than 30 years relies on cervical cytology because of the poor performance of human papillomavirus (HPV) DNA testing in this age group.
  
  
  OBJECTIVE
  To determine the performance of in-cell HPV E6, E7 mRNA quantification (HPV OncoTect) for the detection of high-grade cervical intraepithelial neoplasia in women younger than 30 years.
  
  
  METHODS
  We analyzed 3133 cytology specimens from a screening population of women aged 19-75 years investigate HPV OncoTect as a triage/secondary screening test for atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesion (LSIL) cytology in women younger than 30 years. Test results were compared to histology in 246 cases.
  
  
  RESULTS
  The sensitivity of E6, E7 mRNA was 89% for CIN 2+ and 100% for CIN 3+ lesions in women 30 years and older. In women younger than 30 years, the sensitivity of E6, E7 mRNA for CIN 2+ lesions was 88% for CIN 2+ and 92% for CIN 3+ lesions. Abnormal cytology (≥ASCUS) exhibited a sensitivity of 89% for CIN 2+ and 100% for CIN 3+ in women 30 years and older and 96% sensitivity for CIN 2+ and 93% sensitivity for CIN 3+ in women younger than 30. The specificity of E6, E7 mRNA was >80% for CIN 2+ and CIN 3+ in both groups of women compared to a specificity of abnormal cytology of <10% for CIN 2+ and CIN 3+ in both groups.
  
  
  CONCLUSIONS
  HPV OncoTect demonstrates a performance that would be effective for ASCUS/LSIL triage in women including those younger than 30 years.
authors: Clinical Pathology Department, Hunter Laboratories Inc, Campbell, CA 95008, USA. dpierry@hunterlabs.com
authors: Deirdre
authors: D
authors: Pierry
authors: Gerald
authors: G
authors: Weiss
authors: Benjamin
authors: B
authors: Lack
authors: Victor
authors: V
authors: Chen
authors: Judy
authors: J
authors: Fusco
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D001706:Biopsy; D002584:Cervix Uteri / Q000378:metabolism* / Q000473:pathology / Q000821:virology; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D052689:Gammapapillomavirus / Q000378:metabolism*; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques; D060787:Neoplasm Grading; D009856:Oncogene Proteins, Viral / Q000235:genetics / Q000378:metabolism*; D065006:Papanicolaou Test; D050725:Papillomavirus E7 Proteins / Q000235:genetics / Q000378:metabolism; D011446:Prospective Studies; D012333:RNA, Messenger / Q000378:metabolism; D012367:RNA, Viral / Q000378:metabolism*; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000378:metabolism / Q000473:pathology / Q000821:virology; D014626:Vaginal Smears; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000378:metabolism / Q000473:pathology / Q000821:virology
chemical_list: D009856:Oncogene Proteins, Viral; D050725:Papillomavirus E7 Proteins; D012333:RNA, Messenger; D012367:RNA, Viral