title: Evaluation of a new solid media specimen transport card for high risk HPV detection and cervical cancer prevention.
abstract: BACKGROUND
  Solid media transport can be used to design adaptable cervical cancer screening programs but currently is limited by one card with published data.
  
  
  OBJECTIVE
  To develop and evaluate a solid media transport card for use in high-risk human papillomavirus detection (HR-HPV).
  
  
  METHODS
  The Preventative Oncology International (POI) card was constructed using PK 226 paper(®) treated with cell-lysing solution and indicating dye. Vaginal samples were applied to the POI card and the indicating FTA (iFTA) elute card. A cervical sample was placed in liquid media. All specimens were tested for HR-HPV. Color change was assessed at sample application and at card processing. Stability of the POI card and iFTA elute card was tested at humidity.
  
  
  RESULTS
  319 women were enrolled. Twelve women had at least one insufficient sample with no difference between media (p=0.36). Compared to liquid samples, there was good agreement for HR-HPV detection with kappa of 0.81 (95% CI 0.74-0.88) and 0.71 (95% CI 0.62-0.79) for the POI and iFTA elute card respectively. Sensitivity for ≥CIN2 was 100% (CI 100-100%), 95.1% (CI 92.7-97.6%), and 93.5% (CI 90.7-96.3%) for the HR-HPV test from the liquid media, POI card, and iFTA elute card respectively. There was no color change of the POI card noted in humidity but the iFTA elute card changed color at 90% humidity.
  
  
  CONCLUSIONS
  The POI card is suitable for DNA transport and HR-HPV testing. This card has the potential to make cervical cancer screening programs more affordable worldwide.
authors.affiliation: Gynecologic Oncology Division, Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA. Electronic address: maurerk@ccf.org.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Maurer
authors.affiliation: Department of Ob/Gyn, Peking University Shenzhen Hospital, Shenzhen, PR China.
authors.forename: Hongxue
authors.initials: H
authors.lastname: Luo
authors.affiliation: Hyde Biomedical Corporation, Wuhu City, Anhui, PR China.
authors.forename: Zhiyong
authors.initials: Z
authors.lastname: Shen
authors.affiliation: Department of Ob/Gyn, Peking University Shenzhen Hospital, Shenzhen, PR China.
authors.forename: Guixiang
authors.initials: G
authors.lastname: Wang
authors.affiliation: Department of Ob/Gyn, Peking University Shenzhen Hospital, Shenzhen, PR China.
authors.forename: Hui
authors.initials: H
authors.lastname: Du
authors.affiliation: Department of Ob/Gyn, Peking University Shenzhen Hospital, Shenzhen, PR China.
authors.forename: Chun
authors.initials: C
authors.lastname: Wang
authors.affiliation: Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Xiaobo
authors.initials: X
authors.lastname: Liu
authors.affiliation: BGI Clinical Laboratories, Shenzhen, PR China.
authors.forename: Xiamen
authors.initials: X
authors.lastname: Wang
authors.affiliation: BGI Clinical Laboratories, Shenzhen, PR China; Preventive Oncology International, Cleveland Heights, OH, USA.
authors.forename: Xinfeng
authors.initials: X
authors.lastname: Qu
authors.affiliation: Department of Ob/Gyn, Peking University Shenzhen Hospital, Shenzhen, PR China.
authors.forename: Ruifang
authors.initials: R
authors.lastname: Wu
authors.affiliation: Gynecologic Oncology Division, Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA; Preventive Oncology International, Cleveland Heights, OH, USA.
authors.forename: Jerome
authors.initials: J
authors.lastname: Belinson
mesh_terms: D000328:Adult; D004279:DNA, Viral; D055088:Early Detection of Cancer / Q000191:economics; D005260:Female; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000191:economics / Q000379:methods / Q000592:standards*; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control*; D014621:Vagina / Q000821:virology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000517:prevention & control*
chemical_list: D004279:DNA, Viral
keywords: Cervical cancer screening; High risk HPV testing; Solid media transport