Self-administered home cervicovaginal lavage: a novel tool for the clinical-epidemiologic investigation of genital human papillomavirus infections.

Abstract

Our objective was to evaluate a self-administered cervicovaginal irrigation apparatus (MY-PAP, Medtech, Bohemia, N.Y.) for the detection of cervicovaginal human papillomavirus infection. Twenty-five women referred to a colposcopy clinic because of a recent abnormal Papanicolaou smear were studied. Human papillomavirus infection test results detected by Southern blot hybridization and polymerase chain reaction from physician-administered and MY-PAP self-administered cervicovaginal lavage were paired for comparison. Seventeen (68%) patients returned home samples by mail a mean of 13 days after the clinic visit. All clinic samples and 16 of 17 (94%) home samples yielded adequate deoxyribonucleic acid for human papillomavirus infection analyses. Human papillomavirus infection was detected by polymerase chain reaction in 14 of 16 (88%) samples with complete concordance of viral detection in paired samples from the clinic and home. Southern blot detected human papillomavirus infection in 13 of 25 clinic samples (52%) and 7 of 16 home samples (44%), with concordance in 12 of 16 paired samples (75%). Specific viral type was the same in all positive paired samples (6/6). Concordance was high when the initial sample had a strong (2+ to 4+) human papillomavirus infection signal (5/6, 83%) or a negative result (5/6) or when a dysplastic (cervical intraepithelial neoplasia grade 1 to 3) lesion (9/11, 82%) was seen on cervical biopsy. Self-administered lavage represents an extremely promising technique for obtaining cervicovaginal lavage samples for human papillomavirus infection analyses.