Collection devices for human papillomavirus.
BACKGROUND
Human papillomavirus (HPV) testing has relied to date on samples collected by experienced health professionals. Self-administered testing devices could allow HPV testing to occur in large-scale epidemiologic studies of primary care screening populations. The purpose of this study is to determine whether a self-collection device for cervicovaginal HPV infection could be developed.


METHODS
A prospective randomized trial of a consecutive sampling of 93 women, 18 years or older, receiving routine cervical cancer screening and colposcopy in the urban gynecologic clinics in Philadelphia, Pennsylvania, were randomized into 2 arms. Women in arm 1 used a self-administered tampon before the physician-directed swabs of the cervix; in arm 2, women underwent the physician-directed swab testing before using the self-administered tampon. 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 similar: 78.3% and 80.9%, respectively.


CONCLUSIONS
The tampon was equivalent to the physician-directed swab in HPV detection and suggests its feasibility in long-term primary care studies of screening populations.
Harper
D M
DM
Dartmouth Medical School, Norris Cotton Cancer Center, Hanover, New Hampshire, USA. Diane.M.Harper@Dartmouth.edu
Hildesheim
A
A
Cobb
J L
JL
Greenberg
M
M
Vaught
J
J
Lorincz
A T
AT
D000293:Adolescent; D000328:Adult; D000368:Aged; D004279:DNA, Viral / Q000302:isolation & purification; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000175:diagnosis*; D011446:Prospective Studies; D015203:Reproducibility of Results; D012646:Self Administration; D012680:Sensitivity and Specificity; D012703:Serotyping; D013630:Tampons, Surgical; D014412:Tumor Virus Infections / Q000175:diagnosis*; D014626:Vaginal Smears / Q000295:instrumentation* / Q000379:methods / Q000592:standards
D004279:DNA, Viral