title: The reliability of high-risk human papillomavirus detection by Aptima HPV assay in women with ASC-US cytology.
abstract: BACKGROUND
  The Aptima HPV assay (AHPV) for high-risk human papillomavirus (hrHPV), and the Aptima HPV 16 18/45 Genotype assay (AHPV GT) for HPV16 and for HPV18 and/or HPV45 (HPV18/45) genotypes are approved for cervical cancer screening by the U.S. Food and Drug Administration. There are limited data on the reliability of these tests for detection of hrHPV, HPV16, and HPV18/45.
  
  
  OBJECTIVE
  To assess the reliability of AHPV and AHPV GT on paired specimens from women with atypical squamous cells of undetermined significance (ASC-US) cytology.
  
  
  METHODS
  In a population of women with ASC-US cytology (n=988), cervical specimens were collected at a routine screening baseline visit and at the colposcopy visit that occurred a median of 29 days later. Specimens were tested by AHPV and if positive, by AHPV GT.
  
  
  RESULTS
  There was no significant difference in the percent AHPV positive between the colposcopy and baseline specimens (41.9% vs. 43.0%, respectively, p=0.3). The percent agreement, percent positive agreement, and the kappa value were 88.6%, 76.3%, and 0.766, respectively. There were no significant differences between AHPV testing of the colposcopy and baseline specimen in the sensitivity (95.2% vs. 92.9%, respectively, p=1) and specificity (60.5% vs. 59.2%, respectively, p=0.3) for CIN3+. Comparing the hierarchical AHPV and AHPV GT results on the two specimens, the percent exact agreement was 86.2%, the percent positive agreement was 68.4%, and the kappa value was 0.746.
  
  
  CONCLUSIONS
  AHPV and AHPV GT demonstrated good reliability for hrHPV detection and risk stratification.
authors.affiliation: Albert Einstein College of Medicine, Bronx, NY, USA.
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
authors.affiliation: Hologic, Inc., San Diego, CA, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Reid
authors.affiliation: Hologic, Inc., San Diego, CA, USA.
authors.forename: Janel
authors.initials: J
authors.lastname: Dockter
authors.affiliation: Hologic, Inc., San Diego, CA, USA. Electronic address: damon.getman@hologic.com.
authors.forename: Damon
authors.initials: D
authors.lastname: Getman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D065309:Atypical Squamous Cells of the Cervix / Q000473:pathology* / Q000821:virology*; D003127:Colposcopy; D004279:DNA, Viral / Q000302:isolation & purification; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D005838:Genotype; D061809:Human Papillomavirus DNA Tests / Q000592:standards*; D052162:Human papillomavirus 16 / Q000235:genetics / Q000302:isolation & purification; D052161:Human papillomavirus 18 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology*; D015203:Reproducibility of Results; D014481:United States; D002583:Uterine Cervical Neoplasms / Q000821:virology; D014626:Vaginal Smears; D055815:Young Adult
chemical_list: D004279:DNA, Viral
keywords: Atypical squamous cells of undetermined significance (ASC-US); Cervical cancer; Cervical intraepithelial neoplasia (CIN); Human papillomavirus (HPV); Pap