title: Aptima HPV Assay versus Hybrid Capture®2 HPV test for primary cervical cancer screening in the HPV FOCAL trial.
abstract: Cervical cancer screening programs are switching from Pap screening to high-risk HPV testing.
  
  
  
  To compare the Aptima HPV Assay (AHPV) with the Hybrid Capture®2 High-Risk HPV DNA Test®(HC2) for primary cervical screening.
  
  
  
  HPV FOCAL is a randomized trial comparing HC2 to liquid-based cytology (LBC) for screening women aged 25-65. AHPV and HC2 were compared at the baseline screen (n=3473). Genotyping was by the Aptima HPV 16 18/45 Genotype Assay. We assessed HPV genotyping and reflex LBC for colposcopy triage.
  
  
  
  AHPV/HC2 agreement was 96.5% (kappa 0.76); positive agreement was 77.4%. The AHPV positive rate was 7.2% vs. 8.4% for HC2 (p=0.06). Based on HC2 screening, round 1 CIN2 and CIN3+ rates were 9.2/1000 and 5.2/1000 respectively. Using HC2 as the comparator test, AHPV CIN2+ and CIN3+ relative sensitivities were 0.96 and 1.00 (p=1.00) respectively. High-grade reflex LBC and HPV 16 infection were significantly associated with CIN3+. AHPV specificity was 0.94 vs. 0.93 (p=0.05) for HC2. Compared with triage of HC2+ with abnormal cytology or HPV persistence for 12 months, colposcopy referral would be significantly reduced (38.3/1000 vs. 60.8/1000; p<0.001) if AHPV+ women with abnormal LBC and HPV 16/18/45 were referred at baseline. CIN2+ and CIN3+ detection rates were not significantly different for the two strategies.
  
  
  
  AHPV vs. HC2 screening had equivalent CIN2+ and CIN3+ detection. Triage of AHPV+ by abnormal reflex LBC and the presence of HPV 16/18/45 would result in a significantly lower colposcopy referral rate with similar CIN2+ and CIN3+ detection rates as the overall HC2+ referral algorithm.
authors.affiliation: BC Cancer Agency, 675 West 10th Ave, Vancouver, BC, V5Z 1L3, Canada; BC Centre for Disease Control, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada.
authors.forename: Darrel A
authors.initials: DA
authors.lastname: Cook
authors.affiliation: BC Cancer Agency, 675 West 10th Ave, Vancouver, BC, V5Z 1L3, Canada.
authors.forename: Laurie W
authors.initials: LW
authors.lastname: Smith
authors.affiliation: Lower Mainland Laboratories, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Law
authors.affiliation: Lower Mainland Laboratories, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada.
authors.forename: Wendy
authors.initials: W
authors.lastname: Mei
authors.affiliation: BC Cancer Agency, 675 West 10th Ave, Vancouver, BC, V5Z 1L3, Canada; Lower Mainland Laboratories, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada; University of British Columbia, Faculty of Medicine, 2329 West Mall, Vancouver, BC, V6T 1Z4, Canada.
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: van Niekerk
authors.affiliation: BC Cancer Agency, 675 West 10th Ave, Vancouver, BC, V5Z 1L3, Canada; Lower Mainland Laboratories, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada; University of British Columbia, Faculty of Medicine, 2329 West Mall, Vancouver, BC, V6T 1Z4, Canada.
authors.forename: Kathy
authors.initials: K
authors.lastname: Ceballos
authors.affiliation: BC Cancer Agency, 675 West 10th Ave, Vancouver, BC, V5Z 1L3, Canada.
authors.forename: Lovedeep
authors.initials: L
authors.lastname: Gondara
authors.affiliation: McGill University, Division of Cancer Epidemiology, 546 Pine Ave W, Montreal, QC, H2W 1S6, Canada.
authors.forename: Eduardo L
authors.initials: EL
authors.lastname: Franco
authors.affiliation: BC Cancer Agency, 675 West 10th Ave, Vancouver, BC, V5Z 1L3, Canada; University of British Columbia, Faculty of Medicine, 2329 West Mall, Vancouver, BC, V6T 1Z4, Canada.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Coldman
authors.affiliation: BC Centre for Disease Control, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada; University of British Columbia, Faculty of Medicine, 2329 West Mall, Vancouver, BC, V6T 1Z4, Canada.
authors.forename: Gina S
authors.initials: GS
authors.lastname: Ogilvie
authors.affiliation: McMaster University/St. Joseph's Healthcare, 50 Charlton Ave E, Hamilton, ON, L8N 4A6, Canada.
authors.forename: Dan
authors.initials: D
authors.lastname: Jang
authors.affiliation: McMaster University/St. Joseph's Healthcare, 50 Charlton Ave E, Hamilton, ON, L8N 4A6, Canada.
authors.forename: Max
authors.initials: M
authors.lastname: Chernesky
authors.affiliation: BC Centre for Disease Control, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada; Lower Mainland Laboratories, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada; University of British Columbia, Faculty of Medicine, 2329 West Mall, Vancouver, BC, V6T 1Z4, Canada. Electronic address: mel.krajden@bccdc.ca.
authors.forename: Mel
authors.initials: M
authors.lastname: Krajden
mesh_terms: D000328:Adult; D000368:Aged; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000150:complications*; D016032:Randomized Controlled Trials as Topic; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*
keywords: Cervical cancer screening tests; Cervical intraepithelial neoplasia; Colposcopy triage; Human papillomavirus tests; Papanicolaou test