title: Validation of a low-cost, liquid-based screening method for cervical intraepithelial neoplasia.
abstract: OBJECTIVE
  The objective of the study was to validate a low-cost, liquid-based method for cervical cancer screening.
  
  
  METHODS
  We conducted a retrospective, split-sample comparison of 300 liquid-based cervical cytology samples from a group of 150 human immunodeficiency virus-seropositive women and 150 women from low-risk general gynecology clinics whose specimens were screened via standard liquid-based methodology as part of routine care. Residual samples from each specimen were used to prepare a slide using a novel, inexpensive manual membrane method of liquid-based cytology. These slides were screened by a cytotechnologist and abnormal cases were reviewed by a pathologist. Final diagnoses from the manual membrane method of liquid-based cytology slides were compared with the original diagnoses and available cervical biopsy data.
  
  
  RESULTS
  There was good overall agreement between the manual membrane method of liquid-based cytology and original cytology diagnoses (76.3% agreement; kappa = 0.52, 95% confidence interval 0.44 to 0.59). Using available biopsy data to determine the accuracy of each method to identify high-grade squamous intraepithelial lesions, the manual membrane method of liquid-based cytology method was found to have a higher sensitivity (71.4% versus 57.1%) and lower specificity (82.1% versus 89.7%). The slightly higher referral rate to colposcopy using the manual membrane method of liquid-based cytology method was limited to women from the low-risk general gynecology clinics (16.7% versus 12.0%, P = .05).
  
  
  CONCLUSIONS
  The low-cost manual membrane method of liquid-based cytology cervical cytology method is comparable with a standard commercial method. Consequently, it may be of value in alternative screening strategies in resource-limited settings.
authors.affiliation: Department of Gynecology and Obstetrics, Division of Gynecologic Specialties, The Johns Hopkins University School of Medicine, Baltimore, MD, USA. jleeg@jhmi.edu
authors.forename: Judy M
authors.initials: JM
authors.lastname: Lee
authors.forename: Deidra
authors.initials: D
authors.lastname: Kelly
authors.forename: Patti E
authors.initials: PE
authors.lastname: Gravitt
authors.forename: Zoya
authors.initials: Z
authors.lastname: Fansler
authors.forename: John A
authors.initials: JA
authors.lastname: Maksem
authors.forename: Douglas P
authors.initials: DP
authors.lastname: Clark
mesh_terms: D003581:Cytodiagnosis / Q000191:economics / Q000379:methods*; D005260:Female; D006679:HIV Seropositivity; D017048:Health Care Costs; D006801:Humans; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*