title: Self-test device for cytology and HPV testing in rural Appalachian women: an evaluation.
abstract: OBJECTIVE
  To determine the efficacy of a self-test device for obtaining vaginal/cervical samples for HPV DNA and cytologic testing.
  
  
  METHODS
  We recruited 878 Appalachian women; 775 were able to submit a self-test sample and a provider-collected sample. Each specimen was assessed for cytologic abnormalities and for high-risk HPV infection.
  
  
  RESULTS
  Specimen adequacy: 869 of 878 (99%) women had sufficient material for cytologic analysis in provider-collected samples compared to 771 of 775 (99%) self-collected specimens (p = NS). There was sufficient cellular material (DNA) for HPV testing in 724 of 834 (87%) provider-collected samples compared to 690 of 736 (94%) self-collected specimens (p <0.04). In the provider-collected samples, 654 of 869 (75%) women had endocervical cells compared to 103 of 771 (13%) self-collected specimens (p <0.001). HPV assessment: 142 (19%) had high-risk HPV DNA detected. Of those women, 28 (20%) had HPV infection detected on the provider-collected specimen only, 51 (36%) on the self-collected specimen only, and 63 (44%) had HPV DNA on both specimens.
  
  
  CONCLUSIONS
  Our device is sufficient to obtain an adequate number of epithelial cells for cytologic and HPV testing.
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT 84132, USA. andrew.soisson@hsc.utah.edu
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Soisson
authors.forename: Eddie
authors.initials: E
authors.lastname: Reed
authors.forename: Pamela
authors.initials: P
authors.lastname: Brown
authors.forename: Barbara
authors.initials: B
authors.lastname: Ducatman
authors.forename: Julie
authors.initials: J
authors.lastname: Armistead
authors.forename: Stephanie
authors.initials: S
authors.lastname: Kennedy
authors.forename: Weixen
authors.initials: W
authors.lastname: Wang
authors.forename: Paul
authors.initials: P
authors.lastname: Kramer
authors.forename: Susan
authors.initials: S
authors.lastname: Rose
mesh_terms: D000328:Adult; D001061:Appalachian Region; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000295:instrumentation*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D019035:Rural Health Services; D016353:Self-Examination / Q000295:instrumentation*; D014626:Vaginal Smears / Q000295:instrumentation*