title: The Role of Human Papillomavirus Genotyping in Cervical Cancer Screening: A Large-Scale Evaluation of the cobas HPV Test.
abstract: BACKGROUND
  The cobas HPV Test ("cobas"; Roche Molecular Systems) detects HPV16 and HPV18 individually, and a pool of 12 other high-risk (HR) HPV types. The test is approved for (i) atypical squamous cells of undetermined significance (ASC-US) triage to determine need for colposcopy, (ii) combined screening with cytology ("cotesting"), and (iii) primary HPV screening.
  
  
  METHODS
  To assess the possible value of HPV16/18 typing, >17,000 specimens from a longitudinal cohort study of initially HPV-positive women (HC2, Qiagen) were retested with cobas. To study accuracy, cobas genotyping results were compared with those of an established method, the Linear Array HPV Genotyping Test (LA, Roche Molecular Systems). Clinical value of the typing strategy was evaluated by linking the cobas results (supplemented by other available typing results) to 3-year cumulative risks of CIN3+.
  
  
  RESULTS
  Grouped hierarchically (HPV16, else HPV18, else other HR types, else negative), the κ statistic for agreement between cobas and LA was 0.86 [95% confidence interval (CI), 0.86-0.87]. In all three scenarios, HPV16-positive women were at much higher 3-year risk of CIN3+ than HPV16-negative women: women ages 21 and older with ASC-US (14.5%; 95% CI, 13.5%-15.5% vs. 3.5%; 95% CI, 3.3-3.6); women ages 30 years and older that were HPV-positive cytology-negative (10.3%; 95% CI, 9.6-11.1 vs. 2.3%; 95% CI, 2.2-2.4); and all women 25 years and older that were HPV-positive (18.5%; 95% CI, 17.8-19.2 vs. 4.3%; 95% CI, 4.2-4.4).
  
  
  CONCLUSIONS
  The cobas and LA results show excellent agreement. The data support HPV16 typing.
  
  
  CONCLUSIONS
  HPV16 typing is useful in the management of HPV-positive/cytology-negative women in cotesting, of all HPV-positive women in primary HPV testing, and perhaps in the management of HPV-positive women with ASC-US. Cancer Epidemiol Biomarkers Prev; 24(9); 1304-10.
authors.affiliation: National Cancer Institute, Bethesda, Maryland. schiffmm@mail.nih.gov.
authors.forename: Mark
authors.initials: M
authors.lastname: Schiffman
authors.affiliation: Roche Molecular Systems, Pleasanton, California.
authors.forename: Sean
authors.initials: S
authors.lastname: Boyle
authors.affiliation: Kaiser Permanente Northern California, Oakland, California.
authors.forename: Tina
authors.initials: T
authors.lastname: Raine-Bennett
authors.affiliation: National Cancer Institute, Bethesda, Maryland.
authors.forename: Hormuzd A
authors.initials: HA
authors.lastname: Katki
authors.affiliation: National Cancer Institute, Bethesda, Maryland.
authors.forename: Julia C
authors.initials: JC
authors.lastname: Gage
authors.affiliation: National Cancer Institute, Bethesda, Maryland.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Wentzensen
authors.affiliation: Roche Molecular Systems, Pleasanton, California.
authors.forename: Janet R
authors.initials: JR
authors.lastname: Kornegay
authors.affiliation: Roche Molecular Systems, Pleasanton, California.
authors.forename: Raymond
authors.initials: R
authors.lastname: Apple
authors.affiliation: Roche Molecular Systems, Pleasanton, California.
authors.forename: Carrie
authors.initials: C
authors.lastname: Aldrich
authors.affiliation: Roche Molecular Systems, Pleasanton, California.
authors.forename: Henry A
authors.initials: HA
authors.lastname: Erlich
authors.affiliation: Roche Molecular Systems, Pleasanton, California.
authors.forename: Thanh
authors.initials: T
authors.lastname: Tam
authors.affiliation: Information Management Services, Calverton, Maryland.
authors.forename: Brian
authors.initials: B
authors.lastname: Befano
authors.affiliation: Albert Einstein College of Medicine, The Bronx, New York.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Burk
authors.affiliation: Department of Epidemiology and Population Health, Albert Einstein College of Medicine, The Bronx, New York. Global Coalition Against Cervical Cancer, Arlington, Virginia.
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D065309:Atypical Squamous Cells of the Cervix / Q000473:pathology* / Q000821:virology; D015331:Cohort Studies; D055088:Early Detection of Cancer; D005260:Female; D060005:Genotyping Techniques; D052162:Human papillomavirus 16 / Q000235:genetics*; D052161:Human papillomavirus 18 / Q000235:genetics*; D006801:Humans; D008875:Middle Aged; D012307:Risk Factors; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology