title: Evaluation of human papillomavirus detection by Abbott m2000 system on samples collected by FTA Elute™ Card in a Chinese HIV-1 positive population.
abstract: HIV+/AIDS women have an increased risk of developing into CIN and cervical cancer compared to the general population. Limited medical resource and the lack of AIDS relevant knowledge impair the coverage and efficiency of cervical cancer screening.
  
  
  
  To compare the clinical performance of self-collected dry storage medium (FTA Elute card) and physician-collected PreservCyt medium in detection of high risk human papillomavirus (HR HPV) among HIV-1 positive population.
  
  
  
  Three hundred HIV-1 positive women (aged 25-65) were recruited from Yunnan infectious hospital. Two cervicovaginal samples were collected from each participant: one was collected by the women themselves and applied on a FTA Elute card; the other one was collected by a physician and stored in PreservCyt solution. All the samples were tested for 14 HR HPV using Abbott RealTime High Risk HPV assay. Biopsies were taken for histological diagnosis if any abnormal impression was noticed under colposcopy.
  
  
  
  291 (97.0%) of participants were eligible for this study. 101 (34.70%) participants were found HR HPV positive in both FTA card and PreservCyt samples, and 19 (6.53%) women were diagnosed as CIN2+. The HR HPV positive rate on samples collected by FTA Elute card and PreservCyt solution was 42.61% and 39.86%, respectively. The overall agreement was 87% (kappa=0.731) between FTA card and PreservCyt. The clinical sensitivity and specificity of FTA card and PreservCyt were 100%, 61.39% and 100%, 64.33%, respectively.
  
  
  
  In this study, FTA Elute card demonstrated a good performance on self-collected sample for HR HPV detection in HIV-1 positive population. For the women from low-resource area with HIV-1 infection, FTA Elute card could be an attractive sample collection method for cervical cancer screening.
authors.affiliation: Department of Epidemiology, Public Health College, Dalian Medical University, Dalian, Liaoning Province, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Qin
authors.affiliation: Gynecology Department, the First Affiliated Hospital, Kunming Medical College, Kunming, Yunnan Province, China.
authors.forename: Hongyun
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Research and Development Department, Abbott Molecular, Des Plaines, USA.
authors.forename: Natalia
authors.initials: N
authors.lastname: Marlowe
authors.affiliation: Department of Epidemiology, National Cancer Center, Cancer Hospital & Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Mandong
authors.initials: M
authors.lastname: Fei
authors.affiliation: Research and Development Department, Abbott Molecular, Des Plaines, USA.
authors.forename: Judy
authors.initials: J
authors.lastname: Yu
authors.affiliation: Department of Epidemiology, National Cancer Center, Cancer Hospital & Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Xiaoqin
authors.initials: X
authors.lastname: Lei
authors.affiliation: Department of Epidemiology, National Cancer Center, Cancer Hospital & Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Lulu
authors.initials: L
authors.lastname: Yu
authors.affiliation: Department of Epidemiology, National Cancer Center, Cancer Hospital & Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Jia
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Research and Development Department, Abbott Molecular, Des Plaines, USA.
authors.forename: Di
authors.initials: D
authors.lastname: Cao
authors.affiliation: Department of Epidemiology, Public Health College, Dalian Medical University, Dalian, Liaoning Province, China.
authors.forename: Li
authors.initials: L
authors.lastname: Ma
authors.affiliation: Department of Epidemiology, National Cancer Center, Cancer Hospital & Chinese Academy of Medical Sciences, Beijing, China. Electronic address: chenwen@cicams.ac.cn.
authors.forename: Wen
authors.initials: W
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D002584:Cervix Uteri / Q000821:virology; D002681:China; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000150:complications*; 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*; D016353:Self-Examination / Q000379:methods; D013048:Specimen Handling / Q000379:methods*; D014621:Vagina / Q000821:virology
keywords: Cervical cancer; FTA card; HIV positive; HPV