title: Detection of human papillomavirus 16, 18, and 45 in women with ASC-US cytology and the risk of cervical precancer: results from the CLEAR HPV study.
abstract: OBJECTIVE
  The Aptima human papillomavirus (HPV) 16 18/45 Genotype (GT) assay (AHPV-GT) is a qualitative E6/ E7 oncogene messenger RNA test that detects HPV 16 and a pool of HPV 18 and 45. The CLEAR (Clinical Evaluation of APTIMA mRNA) study was the pivotal, prospective, multicenter US clinical study to validate the Aptima HPV (AHPV) assays.
  
  
  METHODS
  In this analysis, we evaluated the clinical performance of AHPV and AHPV-GT assays for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2 +) and grade 3 (CIN3) or adenocarcinoma in situ in 912 women with atypical squamous cells of undetermined significance (ASC-US) Papanicolaou result. The AHPV-GT assay was performed on high-risk HPV (hrHPV) positives as determined by the AHPV assay.
  
  
  RESULTS
  Overall, the percent positive for hrHPV was 38.8% (354/912), of which 34.2% (121/354) were GT positive. Among hrHPV-positive women, the risks of CIN2 + were 37.0% for HPV 16 positives, 15.9% for HPV 18/45 positives, 14.3% for other hrHPV positives, and 2.2% for AHPV negatives. The risks of CIN3 + were 20.5% for HPV 16 positives, 9.1% for HPV 18/45 positives, 4.3% for other hrHPV positives, and 0.7% for HPV negatives.
  
  
  CONCLUSIONS
  We demonstrated that AHPV-GT is a reliable and effective test for cervical cancer risk stratification in women with an ASC-US cytology diagnosis.
authors.affiliation: From the Albert Einstein College of Medicine, Bronx, NY;
authors.forename: Phillip E
authors.initials: PE
authors.lastname: Castle
authors.affiliation: Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary School of Medicine, London, England;
authors.forename: Jack
authors.initials: J
authors.lastname: Cuzick
authors.affiliation: Department of Pathology, University of Virginia Health System, Charlottesville;
authors.forename: Mark H
authors.initials: MH
authors.lastname: Stoler
authors.affiliation: Department of Pathology, Columbia University School of Medicine, New York, NY; and.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Wright
authors.affiliation: Hologic, San Diego, CA.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Reid
authors.affiliation: Hologic, San Diego, CA.
authors.forename: Janel
authors.initials: J
authors.lastname: Dockter
authors.affiliation: Hologic, San Diego, CA.
authors.forename: Cristina
authors.initials: C
authors.lastname: Giachetti
authors.affiliation: Hologic, San Diego, CA. damon.getman@hologic.com.
authors.forename: Damon
authors.initials: D
authors.lastname: Getman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D065309:Atypical Squamous Cells of the Cervix; D005260:Female; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis*; D012367:RNA, Viral / Q000032:analysis*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014626:Vaginal Smears; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology
chemical_list: D012367:RNA, Viral
keywords: ASC-US; Aptima; Cervical cancer; Cervical intraepithelial neoplasia; E6/E7 mRNA; Genotyping; HPV