title: Age-stratified performance of the Cervista HPV 16/18 genotyping test in women with ASC-US cytology.
abstract: BACKGROUND
  The objective of this study was to evaluate the clinical performance of the Cervista HPV 16/18 genotyping test for detection of human papilloma virus (HPV) 16 and 18 in cervical cytology specimens in women stratified by age.
  
  
  METHODS
  In a multicenter, prospective clinical study, ThinPrep specimens were tested for the presence of HPV 16 and 18 using the HPV 16/18 genotyping test. Genotyping results from women with atypical squamous cells of undetermined significance or greater cytology were compared with local colposcopy and/or histology results. Sensitivity, specificity, and negative and positive predictive values (NPV and PPV) were determined.
  
  
  RESULTS
  The prevalence of cervical intraepithelial neoplasia (CIN) 2(+) in subjects positive for HPV 16/18 was 6.6% and 4.1% for women <30 and ≥30 years of age, respectively. The sensitivity of the test was 70.0% (95% CI: 54.6-81.9) and 66.7% (95% CI: 46.7-82.0) in women <30 and ≥30 years, respectively. The NPV was 95.5% (95% CI: 93.4-97.6) in women <30 years and 96.6% (95% CI: 94.8-98.5) in women ≥30 years. Specificity was higher in women ≥30 years (79.9%; 95% CI: 74.9-84.2) than women <30 years (61.9%; 95% CI: 57.1-66.4). The PPV was 15.2% (95% CI: 12.7-19.1) in women <30 years and 21.9% (95% CI: 17.0-30.7) in women ≥30 years.
  
  
  CONCLUSIONS
  The performance of the Cervista HPV 16/18 genotyping test for predicting ≥CIN 2 is what would be expected across the key ≥CIN 2 age strata.
  
  
  CONCLUSIONS
  HPV 16/18 genotyping may help further stratify women with a greater potential to develop cervical cancer.
authors.affiliation: Albert Einstein College of Medicine and Albert Einstein Cancer Center, Montefiore Medical Center, Bronx, NY 10461, USA. meinstei@montefiore.org
authors.forename: Mark H
authors.initials: MH
authors.lastname: Einstein
authors.forename: Francisco A R
authors.initials: FA
authors.lastname: Garcia
authors.forename: Amy L
authors.initials: AL
authors.lastname: Mitchell
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Day
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000235:genetics / Q000821:virology*; D016022:Case-Control Studies; D002584:Cervix Uteri / Q000473:pathology*; D015331:Cohort Studies; D003127:Colposcopy; D003581:Cytodiagnosis; D004279:DNA, Viral / Q000235:genetics; D005260:Female; D005500:Follow-Up Studies; D052162:Human papillomavirus 16 / Q000235:genetics / Q000302:isolation & purification; D052161:Human papillomavirus 18 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000235:genetics / Q000821:virology*; D011379:Prognosis; D011446:Prospective Studies; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000235:genetics / Q000821:virology*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000235:genetics / Q000821:virology*
chemical_list: D004279:DNA, Viral