Comparison of self-collected vaginal, vulvar and urine samples with physician-collected cervical samples for human papillomavirus testing to detect high-grade squamous intraepithelial lesions

Background: Certain types of human papillomavirus (HPV) in cervical samples are strongly associated with squamous intraepithelial lesions (SIL) and in vasive cervical carcinoma. We determined and compared the test characterist ics of testing for HPV with samples obtained by patients and with samples o btained by their physicians. Methods: In a consecutive series of women referred to a colposcopy clinic a t a teaching hospital because of abnormalities on cervical cytologic screen ing, 200 agreed to collect vulvar, vaginal and urine samples for HPV testin g. The physician then collected cervical samples for HPV testing, and colpo scopy, with biopsy as indicated, was performed. Presence of HPV was evaluat ed using the hybrid capture II assay (Digene Corp., Silver Spring, Md.) wit h a probe cocktail for 13 carcinogenic types. Cervical specimens were also tested for HPV by polymerase chain reaction and hybridization with type-spe cific probes. Cervical smears for cytologic examination were obtained from all women. Results: High-grade lesions (high-grade squamous intraepithelial lesions [H SIL], equivalent to cervical intraepithelial neoplasia [CIN] grade 2 or 3, and adenocarcinoma) were found in 58 (29.0%) of the 200 women. Carcinogenic types of HPV were detected in the self-collected vaginal samples of 50 (86 .2%) of these 58 women, in the self-collected vulvar samples of 36 (62.1%) and in the self-collected urine samples of 26 (44.8%). Carcinogenic types o f HPV were detected in the cervical samples collected by physicians for 57 (98.3%) of these 58 women. The remaining 142 women (71.0%) had normal findi ngs or low-grade squamous intraepithelial lesions (LSIL, CIN grade 1). Test results were negative or noncarcinogenic types of HPV were detected in the self-collected vaginal samples of 76 (53.5%) of these 142 women, in the se lf-collected vulvar samples of 89 (62.7%) and in the self-collected urine s amples of 99 (69.7%). The sensitivity for self-collected samples ranged fro m 44.8% to 86.2%, and the specificity from 53.5% to 69.7%. For the samples collected by physicians, the sensitivity was 98.3% and the specificity 52.1 %. The self-sampling methods were generally acceptable to the women: 98.4% of respondents (126/128) deemed urine sampling acceptable, 92.9% (118/127) found vulvar sampling acceptable, and 88.2% (112/127) found vaginal samplin g acceptable. Interpretation: Self-collection of samples for HPV testing was acceptable t o women attending a colposcopy clinic for investigation of suspected cervic al lesions and shows sufficient sensitivity to warrant further evaluation a s a screening test for cervical cancer prevention programs.