title: Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study.
abstract: Self-sampling could increase cervical cancer screening uptake. While methods have been identified for human papillomavirus (HPV) testing, to date, self-sampling has not provided adequate specimens for cytology. We piloted the validity and reliability of using a self-lavaging device for cervical cytology and HPV testing. We enrolled 198 women in New York City in 2008-2009 from three ambulatory clinics where they received cervical cancer screening. All were asked to use the Delphi Screener™ to self-lavage 1-3 months after clinician-collected index cytological smear (100 normal; 98 abnormal). Women with abnormal cytology results from either specimen underwent colposcopy; 10 women with normal results from both specimens also underwent colposcopy. We calculated sensitivity of self-collected cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results. One hundred and ninety-seven (99.5%) women self-collected a lavage. Seventy-five percent had moderate to excellent cellularity, two specimens were unsatisfactory for cytology. Seven of 167 (4%) women with definitive results had CIN2+; one had normal and six abnormal cytology results with the self-lavage (sensitivity = 86%, 95% Confidence Interval, CI: 42, 100). The kappa for paired cytology was low (0.36; 95% CI: 0.25, 0.47) primarily due to clinician specimens with atypical squamous cells of undetermined significance (ASC-US) and low grade squamous intraepithelial lesion (LSIL) coded as normal using Screener specimens. However, three cases of HSIL were coded as ASC-US and one as normal using Screener specimens. Seventy-three women had paired high-risk HPV tests with a kappa of 0.66 (95% CI: 0.49, 0.84). Based on these preliminary findings, a larger study to estimate the performance of the Screener for co-testing cytology and HPV or for HPV testing with cytology triage is warranted.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00702208.
authors.affiliation: Department of Obstetrics & Gynecology, Columbia University Medical Center, New York, New York, United States of America ; Epidemiology & Biostatistics Program, City University of New York School of Public Health and Hunter College, New York, New York, United States of America.
authors.forename: Heidi E
authors.initials: HE
authors.lastname: Jones
authors.affiliation: Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York, United States of America.
authors.forename: Mahesh M
authors.initials: MM
authors.lastname: Mansukhani
authors.affiliation: Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York, United States of America.
authors.forename: Guo-Xia
authors.initials: GX
authors.lastname: Tong
authors.affiliation: Department of Obstetrics & Gynecology, Columbia University Medical Center, New York, New York, United States of America.
authors.forename: Carolyn L
authors.initials: CL
authors.lastname: Westhoff
mesh_terms: D000328:Adult; D003581:Cytodiagnosis / Q000295:instrumentation*; D003710:Demography; D055088:Early Detection of Cancer / Q000295:instrumentation* / Q000379:methods*; D005260:Female; D006801:Humans; D009518:New York; D009519:New York City / Q000453:epidemiology; D027383:Papillomaviridae / Q000302:isolation & purification*; D010865:Pilot Projects; D012680:Sensitivity and Specificity; D013048:Specimen Handling; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000453:epidemiology / Q000473:pathology* / Q000821:virology*; D044364:Vaginal Douching / Q000295:instrumentation*