title: [High-risk human papilloma virus DNA detection kit (cervista HPV HR) should be highly validated clinically in cervical cancer screening programs].
abstract: OBJECTIVE
  The aim of this study is to evaluate the clinical significance of High-risk Human Papilloma virus DNA Detection Kit (Cervista HPV HR) designed to the utilized in cervical cancer screening programs.
  
  
  METHODS
  The investigation for Cervista HPV HR test is designed to detect 437 residual liquid-based cytology specimens collected during routine liquid-based Pap tests at standard care vistis and to identify the presence of HR HPV. We compared Cervista HPV HR Test against standard PCR, in order to examine the performance of Cervista HPV HR Test in populations with cervical intraepithelial neoplasia grade 2+ (CIN 2, CIN 3 and Cancer, CIN 2+), and the capabilities of A5/A6, A7, A9 oligonucleotides of Cervista for predicting CIN2+.
  
  
  RESULTS
  The accuracy of Cervista compared to PCR with bi-directional sequencing was 88.26%. The positive percent of Cervista HPV HR Test and PCR were 38.96% and 29.08%, respectively. The sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of Cervista HPV HR Test for the detection of CIN2+ were 98.46%, 58.49%, 99.54% and 29.68%, respectively. The A9 oligonucleotides positivity percent was significantly higher in CIN2 + (odds ratio: 24.037, 95% CI: 10.086 - 57.283).
  
  
  CONCLUSIONS
  The Cervista HPV HR test can be clinically used for detecting HR HPV types during routine cervical cancer screening. A9 oligonucleotides were also strongly associated with CIN2+ diagnosis, which is improtant in cervical cancer screening for triage to colposcopy.
authors.affiliation: Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing 100034, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Zhao
authors.forename: Xiao-guang
authors.initials: XG
authors.lastname: Zhang
authors.forename: Rui
authors.initials: R
authors.lastname: Chen
authors.forename: Hui
authors.initials: H
authors.lastname: Bi
authors.forename: Xu
authors.initials: X
authors.lastname: Wang
authors.forename: Gui-wen
authors.initials: GW
authors.lastname: Liu
authors.forename: Dian-xin
authors.initials: DX
authors.lastname: Yao
authors.forename: Yi
authors.initials: Y
authors.lastname: Zong
authors.forename: Qin-ping
authors.initials: QP
authors.lastname: Liao
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D052685:Alphapapillomavirus / Q000235:genetics / Q000302:isolation & purification*; D004279:DNA, Viral / Q000235:genetics; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D011933:Reagent Kits, Diagnostic; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D055815:Young Adult
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic