Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study

PLoS One. 2013 Dec 20;8(12):e82115. doi: 10.1371/journal.pone.0082115. eCollection 2013.

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.

Trial registration: ClinicalTrials.gov NCT00702208.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adult
  • Cytodiagnosis / instrumentation*
  • Demography
  • Early Detection of Cancer / instrumentation*
  • Early Detection of Cancer / methods*
  • Female
  • Humans
  • New York
  • New York City / epidemiology
  • Papillomaviridae / isolation & purification*
  • Pilot Projects
  • Sensitivity and Specificity
  • Specimen Handling
  • Uterine Cervical Neoplasms / diagnosis
  • Uterine Cervical Neoplasms / epidemiology
  • Uterine Cervical Neoplasms / pathology*
  • Uterine Cervical Neoplasms / virology*
  • Vaginal Douching / instrumentation*

Associated data

  • ClinicalTrials.gov/NCT00702208

Grants and funding

Delphi Bioscience (Scherpenzeel, Netherlands) funded this study as a research grant to Columbia University, including salary support for HEJ. Delphi staff commented on study design but had no role in data collection and analysis, decision to publish, or preparation of the manuscript.