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

• Published in: PloS one 2013-12, Vol.8 (12), p.e82115-e82115
• Main Authors: Jones, Heidi E, Mansukhani, Mahesh M, Tong, Guo-Xia, Westhoff, Carolyn L
• Format: Article
• Language: English
• Subjects: Adult; Cancer; Cancer research; Cancer screening; Cellular biology; Cervical cancer; Cervix; Colposcopy; Confidence intervals; Cytodiagnosis - instrumentation; Cytology; Demography; Early Detection of Cancer - instrumentation; Early Detection of Cancer - methods; Female; Gynecology; Histology; Human papillomavirus; Humans; Identification methods; Irrigation; Laboratories; Lesions; Medical screening; New York; New York City - epidemiology; Obstetrics; Papillomaviridae - isolation & purification; Pilot Projects; Reliability; Sample size; Sampling; Screening; Sensitivity; Sensitivity and Specificity; Smear; Specimen Handling; Squamous cells; Uterine Cervical Neoplasms - diagnosis; Uterine Cervical Neoplasms - epidemiology; Uterine Cervical Neoplasms - pathology; Uterine Cervical Neoplasms - virology; Vaginal Douching - instrumentation; Womens health
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0082115

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. ClinicalTrials.gov NCT00702208.