title: An Evaluation of the Cobas4800 HPV Test on Cervico-Vaginal Specimens in Liquid versus Solid Transport Media.
abstract: OBJECTIVE
  Determine the ability of the Cobas 4800 assay to detect high-risk human papillomavirus (HrHPV) and high-grade cervical lesions when using cervico-vaginal samples applied to liquid medium and solid media cards compared to a direct cervical sample.
  
  
  METHODS
  Two cervico-vaginal specimens (pseudo self-collected) were obtained from 319 women. One was applied to an iFTA Card (FTA) then the brush placed in liquid-based medium (LSELF); the other was applied to a new solid media: POI card (POI). The clinical performance of Cobas4800 assay using the three aforementioned specimens was compared to direct collected endocervical specimens in liquid media (LDOC).
  
  
  RESULTS
  The overall agreements of HrHPV detection were 84.2% (LSELF vs. LDOC), 81.0% (FTA vs. LDOC), and 82.3% (POI vs. LDOC). LSELF, FTA and POI identified 98.0%, 79.6%, and 97.5% positive cases of LDOC. Sensitivity to identify CIN2+ were 98.4% (LSELF), 73.8% (FTA), 95.1% (POI), and 93.4% (LDOC) respectively. FTA had 78.1% and 90.4% agreement with the LSELF samples for all HrHPV and HPV16/18 detection respectively, while POI had 91.6% for both.
  
  
  CONCLUSIONS
  Cobas4800 HPV test combined with cervico-vaginal specimens applied to both liquid media and POI solid card are accurate to detect HrHPV infection and high-grade cervical lesions as compared with direct endocervical samples in liquid media.
authors.affiliation: Department of obstetrics/gynaecology, Peking University Shenzhen Hospital, Shenzhen, PR China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Hongxue
authors.initials: H
authors.lastname: Luo
authors.affiliation: Department of obstetrics/gynaecology, Peking University Shenzhen Hospital, Shenzhen, PR China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Hui
authors.initials: H
authors.lastname: Du
authors.affiliation: Gynecologic Oncology Division, Women's Health Institute, Cleveland Clinic, Cleveland, Ohio, United States of America.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Maurer
authors.affiliation: Gynecologic Oncology Division, Women's Health Institute, Cleveland Clinic, Cleveland, Ohio, United States of America.|Preventive Oncology International, Cleveland Heights, Ohio, United States of America.
authors.forename: Jerome L
authors.initials: JL
authors.lastname: Belinson
authors.affiliation: Department of obstetrics/gynaecology, Peking University Shenzhen Hospital, Shenzhen, PR China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Guixiang
authors.initials: G
authors.lastname: Wang
authors.affiliation: Department of obstetrics/gynaecology, Peking University Shenzhen Hospital, Shenzhen, PR China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Zhihong
authors.initials: Z
authors.lastname: Liu
authors.affiliation: Department of obstetrics/gynaecology, Peking University Shenzhen Hospital, Shenzhen, PR China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Lijie
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Department of obstetrics/gynaecology, Peking University Shenzhen Hospital, Shenzhen, PR China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Yanqiu
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: Department of obstetrics/gynaecology, Peking University Shenzhen Hospital, Shenzhen, PR China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Chun
authors.initials: C
authors.lastname: Wang
authors.affiliation: Department of obstetrics/gynaecology, Peking University Shenzhen Hospital, Shenzhen, PR China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Jinlong
authors.initials: J
authors.lastname: Tang
authors.affiliation: Preventive Oncology International, Cleveland Heights, Ohio, United States of America.
authors.forename: Xinfeng
authors.initials: X
authors.lastname: Qu
authors.affiliation: Department of obstetrics/gynaecology, Peking University Shenzhen Hospital, Shenzhen, PR China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Ruifang
authors.initials: R
authors.lastname: Wu
mesh_terms: D000328:Adult; D000368:Aged; D001681:Biological Assay; D002584:Cervix Uteri / Q000473:pathology / Q000821:virology*; D003470:Culture Media; D019937:Diagnostic Techniques and Procedures; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics / Q000502:physiology*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D014621:Vagina / Q000473:pathology / Q000821:virology*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000473:pathology / Q000821:virology
chemical_list: D003470:Culture Media
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