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Department of Human Genetics, Roche Molecular Systems, Alameda, California 94501 [P. E. G., J. R. K.]; Environmental Epidemiology Branch, National Cancer Institute, Rockville, Maryland 20852-7234 [P. E. G., J. V. L., L. A. B., A. H.]; Lombardi Cancer Center, Georgetown University, Washington, DC 20057 [W. A. B.]; Graduate Hospital, Philadelphia, Pennsylvania 19146 [M. D. G.]; Westat, Inc., Rockville, Maryland 20850 [S. M. G.]; Yale University School of Medicine, New Haven, Connecticut 06520 [O. C. H., P. E. S.]; George Washington University, Washington, DC 20052 [L. M.]; and Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033 [R. M., R. Z.]
As human papillomavirus (HPV) becomes accepted as the central cause of
cervical cancer, longitudinal studies are shifting focus away from
causality to a more detailed investigation of the natural history of
HPV infections. These studies commonly require repeated samples for HPV
testing over several years, usually collected during a pelvic
exam, which is inconvenient to the participants and costly to the
study. To alleviate the inconvenience and cost of repeated clinic
visits, it has been proposed that women collect cervicovaginal cells
themselves, hopefully increasing participation in the natural history
studies. We evaluated the technical feasibility of self-collection of
cervicovaginal cells using a Dacron swab for HPV DNA detection. We
compared the self-collected swab sample and two clinician-administered
swab samples (one from the endocervix and another from the ectocervix)
from a total of 268 women participating in a case-control study of
adenocarcinoma and squamous cell carcinomas of the uterine cervix (111
cases and 157 controls). HPV DNA was detected and genotyped using an L1
consensus PCR assay. The overall agreement between the clinician- and
self-collected swabs was excellent [88.1%; 
= 0.73 (95%
confidence interval (CI), 0.61–0.85)]. The correlation was highest
between the two clinician-administered swabs [ = 0.81 (95%
CI, 0.69–0.93)] but was still excellent when comparing either
clinician-administered swab to the self-administered sample [
= 0.75 (95% CI, 0.63–0.87) and 0.67 (95% CI, 0.55–0.79) for
ectocervix and endocervix, respectively]. The type-specific agreement
between samples was higher for high-risk, or cancer-associated, HPV
genotypes than for low risk, noncancer-associated HPV genotypes when
comparing the self-administered swab sample to the
clinician-administered swab sample ( = 0.78 for high-risk
versus 0.66 for low-risk HPV infections,
t = -1.45, P = 0.15). The
decrease in agreement for low risk types was largely attributable to an
increased detection of these types in the self-administered sample
(McNemar’s 
2 = 6.25, P = 0.01
for clinician- versus self-administered swab
comparisons). The agreement did not vary significantly by age,
menopausal status, case status, or clinic center. We have demonstrated
that a self-collected Dacron swab sample of cervicovaginal cells is a
technically feasible alternative to clinician-administered cervical
cell collection in natural history studies of HPV and cervical cancer.
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