Collection devices for human papillomavirus

BACKGROUND. Human papillomavirus (HPV) testing has relied to date on sample s collected by experienced health professionals. Self-administered testing devices could allow HPV testing to occur in large-scale epidemiologic studi es of primary care screening populations. The purpose of this study is to d etermine whether a self-collection device for cervicovaginal HPV infection could be developed. METHODS. A prospective randomized trial of a consecutive sampling of 93 wom en, 18 years or older, receiving routine cervical cancer screening and colp oscopy in the urban gynecologic clinics in Philadelphia, Pennsylvania, were randomized into 2 arms. Women in arm 1 used a self-administered tampon bef ore the physician-directed swabs of the cervix; in arm 2, women underwent t he physician-directed swab testing before using the self-administered tampo n. The concordance of HPV DNA positivity between sampling methods detected by a Hybrid Capture HPV tube test for both low- and high-risk types of HPV was the main outcome measure. RESULTS. The concordance rate (ie, women whose cultures were classified as negative on both tests or positive on both tests) for arms 1 and 2 were sim ilar: 78.3% and 80.9%, respectively. CONCLUSIONS. The tampon was equivalent to the physician-directed swab in HP V detection and suggests its feasibility in long-term primary care studies of screening populations.