title: Prevalence of type-specific human papillomavirus in endocervical, upper and lower vaginal, perineal and vaginal self-collected specimens: Implications for vaginal self-collection.
abstract: To determine why a vaginal self-collection tested for high-risk human papillomavirus (HR-HPV) by Hybrid Capture 2(R) (hc2) has lower sensitivity and specificity for cervical intraepithelial neoplasia Grade 2 or worse (> or = CIN 2), we collected 5 specimens (endocervix, upper and lower vagina, perineum, vaginal self-collection) from 2,625 women. Endocervical and self-collected specimens had HR-HPV tests by hc2. All 5 anogenital specimens were tested for 37 HPV genotypes [Linear Array(R), (LA)] from 397 women hc2 positive in endocervical or self-collected specimens and for a randomly selected 71 of 2,228 women hc2 negative on both specimens. Three hundred nintey-five women who screened positive by hc2 or had abnormal cytology underwent colposcopic evaluation. Of 47 women with > or = CIN 2, hc2 was positive in 97.9% (46/47) of endocervical and 80.9% (38/47), p = 0.008 of self-collected specimens. Seven of 9 women with > or = CIN 2 and negative self-collected hc2 tests were positive for HR-HPV by LA. Of 2,578 women without > or = CIN 2, hc2 was positive in 9.8% (253/2,578) of endocervical and 11.4% (294/2,578), p = 0.001 of self-collected specimens. Of the 41 more women without > or = CIN 2 that tested hc2 positive on the self-collected but negative on endocervical specimen, LA tested positive for HR-HPV in 24, negative for HPV in 11 and negative for HR-HPV but positive for low-risk HPV in 6. Lower sensitivity of self-collected specimens is secondary to lower levels of vaginal HR-HPV. The principal cause of the lower specificity of self-collected specimens is HR-HPV present solely in the vagina, which is not associated with > or = CIN 2.
authors.affiliation: Department of Gynecology, The Cleveland Clinic Foundation, Cleveland, OH, USA.
authors.forename: Jerome L
authors.initials: JL
authors.lastname: Belinson
authors.forename: Shangying
authors.initials: S
authors.lastname: Hu
authors.forename: Mayineur
authors.initials: M
authors.lastname: Niyazi
authors.forename: Robert G
authors.initials: RG
authors.lastname: Pretorius
authors.forename: He
authors.initials: H
authors.lastname: Wang
authors.forename: Chen
authors.initials: C
authors.lastname: Wen
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Smith
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Taddeo
authors.forename: Raoul J
authors.initials: RJ
authors.lastname: Burchette
authors.forename: You-Lin
authors.initials: YL
authors.lastname: Qiao
mesh_terms: D000293:Adolescent; D000328:Adult; D002584:Cervix Uteri / Q000821:virology*; D003127:Colposcopy; D003430:Cross-Sectional Studies; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000453:epidemiology / Q000821:virology*; D011237:Predictive Value of Tests; D015995:Prevalence; D012680:Sensitivity and Specificity; D013048:Specimen Handling; D002583:Uterine Cervical Neoplasms / Q000453:epidemiology / Q000821:virology*; D014621:Vagina / Q000821:virology*; D014626:Vaginal Smears / Q000379:methods; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000453:epidemiology / Q000821:virology*
chemical_list: D004279:DNA, Viral