title: The concordance of HPV DNA detection by Hybrid Capture 2 and careHPV on clinician- and self-collected specimens.
abstract: BACKGROUND
  careHPV is a new, lower-cost DNA test for human papillomavirus (HPV). There are limited analytic comparisons of careHPV against a referent HPV DNA test like Hybrid Capture 2 (HC2).
  
  
  OBJECTIVE
  To assess the test agreement between careHPV and HC2 on self- and clinician-collected specimens.
  
  
  METHODS
  In a population of 7541 women living in rural China, women provided a self-collected (sc) and two clinician-collected (cc) specimens and underwent visual inspection after acetic acid (VIA). The sc specimen and one cc specimen were tested by careHPV and HC2; a random subset of specimens was tested for HPV genotypes.
  
  
  RESULTS
  The percent positive on cc specimens and sc specimens was 14.69% and 14.97% for careHPV, respectively, and 15.05% and 18.53% for HC2, respectively; HC2 testing of sc specimens was more likely to test positive than other combinations of tests and specimens (p<0.0001 for all comparisons). The agreement between different tests on the same specimens (kappa=0.787 and 0.691 for cc and sc specimens, respectively) was better than the same test on different specimens (kappa=0.653 and 0.649 for HC2 and careHPV, respectively). Disagreement between the same test on different specimens increased with increasing participant age (ptrend=0.0001 for HC2 and 0.002 for careHPV). HC2-positive/careHPV-negative specimens were more likely to test positive for non-carcinogenic HPV genotype than test HPV negative whereas the converse was true for HC2-negative/careHPV-positive specimens.
  
  
  CONCLUSIONS
  The agreement for HPV DNA detection between careHPV and HC2 was good to very good.
authors.affiliation: Department of Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Wen
authors.initials: W
authors.lastname: Chen
authors.affiliation: PATH, Seattle, WA, USA.
authors.forename: Jose
authors.initials: J
authors.lastname: Jeronimo
authors.affiliation: Department of Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Fang-Hui
authors.initials: FH
authors.lastname: Zhao
authors.affiliation: Department of Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: You-Lin
authors.initials: YL
authors.lastname: Qiao
authors.affiliation: PATH, Seattle, WA, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Valdez
authors.affiliation: Department of Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Xun
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Le-Ni
authors.initials: LN
authors.lastname: Kang
authors.affiliation: PATH, Seattle, WA, USA.
authors.forename: Pooja
authors.initials: P
authors.lastname: Bansil
authors.affiliation: PATH, Seattle, WA, USA.
authors.forename: Proma
authors.initials: P
authors.lastname: Paul
authors.affiliation: Department of Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Ping
authors.initials: P
authors.lastname: Bai
authors.affiliation: PATH, Seattle, WA, USA.
authors.forename: Roger
authors.initials: R
authors.lastname: Peck
authors.affiliation: Department of Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Feng
authors.initials: F
authors.lastname: Chen
authors.affiliation: Department of Pathology, University of Virginia, Charlottesville, VA, USA.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Stoler
authors.affiliation: Global Coalition Against Cervical Cancer, Arlington, VA, USA. Electronic address: castle.philip@gmail.com.
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
mesh_terms: D000328:Adult; D002681:China; D004279:DNA, Viral / Q000235:genetics / Q000302:isolation & purification*; D005260:Female; D005838:Genotype; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D012424:Rural Population; D013048:Specimen Handling / Q000379:methods*
chemical_list: D004279:DNA, Viral
keywords: Cervical cancer; Cervical intraepithelial neoplasia (CIN); Human papillomavirus (HPV); Visual inspection after acetic acid (VIA)