title: Evaluation of self-collected cervicovaginal cell samples for human papillomavirus testing by polymerase chain reaction.
abstract: 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%; kappa = 0.73 (95% confidence interval (CI), 0.61-0.85)]. The correlation was highest between the two clinician-administered swabs [kappa = 0.81 (95% CI, 0.69-0.93)] but was still excellent when comparing either clinician-administered swab to the self-administered sample [kappa = 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 (kappa = 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 chi2 = 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.
authors.affiliation: Department of Human Genetics, Roche Molecular Systems, Alameda, California 94501, USA. gravittp@mail.nih.gov
authors.forename: P E
authors.initials: PE
authors.lastname: Gravitt
authors.forename: J V
authors.initials: JV
authors.lastname: Lacey
authors.forename: L A
authors.initials: LA
authors.lastname: Brinton
authors.forename: W A
authors.initials: WA
authors.lastname: Barnes
authors.forename: J R
authors.initials: JR
authors.lastname: Kornegay
authors.forename: M D
authors.initials: MD
authors.lastname: Greenberg
authors.forename: S M
authors.initials: SM
authors.lastname: Greene
authors.forename: O C
authors.initials: OC
authors.lastname: Hadjimichael
authors.forename: L
authors.initials: L
authors.lastname: McGowan
authors.forename: R
authors.initials: R
authors.lastname: Mortel
authors.forename: P E
authors.initials: PE
authors.lastname: Schwartz
authors.forename: R
authors.initials: R
authors.lastname: Zaino
authors.forename: A
authors.initials: A
authors.lastname: Hildesheim
mesh_terms: D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000368:Aged; D016022:Case-Control Studies; D016001:Confidence Intervals; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000453:epidemiology; D010358:Patient Participation; D016133:Polymerase Chain Reaction / Q000379:methods*; D015995:Prevalence; D012307:Risk Factors; D012494:Sampling Studies; D012680:Sensitivity and Specificity; D014412:Tumor Virus Infections / Q000175:diagnosis* / Q000453:epidemiology; D014626:Vaginal Smears / Q000379:methods*
chemical_list: D004279:DNA, Viral