title: Feasibility and accuracy evaluation of three human papillomavirus assays for FTA card-based sampling: a pilot study in cervical cancer screening.
abstract: BACKGROUND
  Liquid-state specimen carriers are inadequate for sample transportation in large-scale screening projects in low-resource settings, which necessitates the exploration of novel non-hazardous solid-state alternatives. Studies investigating the feasibility and accuracy of a solid-state human papillomavirus (HPV) sampling medium in combination with different down-stream HPV DNA assays for cervical cancer screening are needed.
  
  
  METHODS
  We collected two cervical specimens from 396 women, aged 25-65 years, who were enrolled in a cervical cancer screening trial. One sample was stored using DCM preservative solution and the other was applied to a Whatman Indicating FTA Elute® card (FTA card). All specimens were processed using three HPV testing methods, including Hybrid capture 2 (HC2), careHPV™, and Cobas®4800 tests. All the women underwent a rigorous colposcopic evaluation that included using a microbiopsy protocol.
  
  
  RESULTS
  Compared to the liquid-based carrier, the FTA card demonstrated comparable sensitivity for detecting high grade Cervical Intraepithelial Neoplasia (CIN) using HC2 (91.7 %), careHPV™ (83.3 %), and Cobas®4800 (91.7 %) tests. Moreover, the FTA card showed a higher specificity compared to a liquid-based carrier for HC2 (79.5 % vs. 71.6 %, P = 0.015), comparable specificity for careHPV™ (78.1 % vs. 73.0 %, P > 0.05), but lower specificity for the Cobas®4800 test (62.4 % vs. 69.9 %, P = 0.032). Generally, the FTA card-based sampling medium's accuracy was comparable with that of liquid-based medium for the three HPV testing assays.
  
  
  CONCLUSIONS
  FTA cards are a promising sample carrier for cervical cancer screening. With further optimization, it can be utilized for HPV testing in areas of varying economic development.
authors.affiliation: Cancer Institute/Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, P.O. Box 2258, 17 South Panjiayuan Lane, Beijing, 100021, China. wangshaoming@cicams.ac.cn.
authors.forename: Shao-Ming
authors.initials: SM
authors.lastname: Wang
authors.affiliation: Cancer Institute/Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, P.O. Box 2258, 17 South Panjiayuan Lane, Beijing, 100021, China. shangyinghu@cicams.ac.cn.
authors.forename: Shang-Ying
authors.initials: SY
authors.lastname: Hu
authors.affiliation: Cancer Institute/Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, P.O. Box 2258, 17 South Panjiayuan Lane, Beijing, 100021, China. chenwen@cicams.ac.cn.
authors.forename: Wen
authors.initials: W
authors.lastname: Chen
authors.affiliation: Cancer Institute/Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, P.O. Box 2258, 17 South Panjiayuan Lane, Beijing, 100021, China. chenfeng915@tom.com.
authors.forename: Feng
authors.initials: F
authors.lastname: Chen
authors.affiliation: Cancer Institute/Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, P.O. Box 2258, 17 South Panjiayuan Lane, Beijing, 100021, China. zhaofangh@cicams.ac.cn.
authors.forename: Fang-Hui
authors.initials: FH
authors.lastname: Zhao
authors.affiliation: Cancer Institute/Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, P.O. Box 2258, 17 South Panjiayuan Lane, Beijing, 100021, China. 545875763@qq.com.
authors.forename: Wei
authors.initials: W
authors.lastname: He
authors.affiliation: Cancer Institute/Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, P.O. Box 2258, 17 South Panjiayuan Lane, Beijing, 100021, China. maxinming2009@163.com.
authors.forename: Xin-Ming
authors.initials: XM
authors.lastname: Ma
authors.affiliation: Cancer Institute/Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, P.O. Box 2258, 17 South Panjiayuan Lane, Beijing, 100021, China. yqzhang2010@hotmail.com.
authors.forename: Yu-Qing
authors.initials: YQ
authors.lastname: Zhang
authors.affiliation: Cancer Institute/Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, P.O. Box 2258, 17 South Panjiayuan Lane, Beijing, 100021, China. 591430941@qq.com.|Beijing Municipal Institute of Labour Protection, Beijing, 100021, China. 591430941@qq.com.
authors.forename: Jian
authors.initials: J
authors.lastname: Wang
authors.affiliation: Cancer Institute/Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, P.O. Box 2258, 17 South Panjiayuan Lane, Beijing, 100021, China. priyagsiva@gmail.com.|Vanderbilt University School of Medicine, Nashville, TN, 37212, USA. priyagsiva@gmail.com.
authors.forename: Priya
authors.initials: P
authors.lastname: Sivasubramaniam
authors.affiliation: Cancer Institute/Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, P.O. Box 2258, 17 South Panjiayuan Lane, Beijing, 100021, China. qiaoy@cicams.ac.cn.
authors.forename: You-Lin
authors.initials: YL
authors.lastname: Qiao
mesh_terms: D000328:Adult; D000368:Aged; D004279:DNA, Viral / Q000235:genetics*; D055088:Early Detection of Cancer / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005838:Genotype; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D010865:Pilot Projects; D015203:Reproducibility of Results; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology
chemical_list: D004279:DNA, Viral