title: Improved sensitivity of vaginal self-collection and high-risk human papillomavirus testing.
abstract: Self-collected vaginal specimens tested for high-risk human papillomavirus (HR-HPV) have been shown to be less sensitive for the detection of cervical intraepithelial neoplasia or cancer (≥CIN 3) than physician-collected endocervical specimens. To increase the sensitivity of self-collected specimens, we studied a self-sampling device designed to obtain a larger specimen from the upper vagina (POI/NIH self-sampler) and a more sensitive polymerase chain reaction (PCR)-based HR-HPV assay. Women (10,000) were screened with cervical cytology and HR-HPV testing of vaginal self-collected and endocervical physician-collected specimens. Women were randomly assigned to use either a novel self-collection device (POI/NIH self-sampler) or conical-shaped brush (Qiagen). The self-collected and clinician-collected specimens were assayed by Cervista (Hologic) and the research only PCR-based matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF). Women with any abnormal screening test underwent colposcopy and biopsy. Women (8,556), mean age of 38.9, had complete data; 1.6% had ≥ CIN 3. For either HR-HPV assay, the sensitivity was similar for the two self-collection devices. Tested with Cervista, the sensitivity for ≥CIN 3 of self-collected specimens was 70.9% and for endocervical specimens was 95.0% (p = 0.0001). Tested with MALDI-TOF, the sensitivity for ≥CIN 3 of self-collected specimens was 94.3% and for endocervical specimens was also 94.3% (p = 1.0). A self-collected sample using a PCR-based assay with the capability of very high throughput has similar sensitivity as a direct endocervical specimen obtained by a physician. Large population-based screening "events" in low-resource settings could be achieved by promoting self-collection and centralized high-throughput, low-cost testing by PCR-based MALDI-TOF.
authors.affiliation: Preventive Oncology International, Inc. Cleveland Heights, OH, USA. jlb@poiinc.org
authors.forename: Jerome L
authors.initials: JL
authors.lastname: Belinson
authors.forename: Hui
authors.initials: H
authors.lastname: Du
authors.forename: Bin
authors.initials: B
authors.lastname: Yang
authors.forename: Ruifang
authors.initials: R
authors.lastname: Wu
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Belinson
authors.forename: Xinfeng
authors.initials: X
authors.lastname: Qu
authors.forename: Robert G
authors.initials: RG
authors.lastname: Pretorius
authors.forename: Xin
authors.initials: X
authors.lastname: Yi
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
mesh_terms: D000328:Adult; D052685:Alphapapillomavirus / Q000235:genetics / Q000302:isolation & purification; D003127:Colposcopy; D003430:Cross-Sectional Studies; D005260:Female; D005838:Genotype; D006801:Humans; D008403:Mass Screening / Q000295:instrumentation / Q000379:methods; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology*; D016133:Polymerase Chain Reaction; D015203:Reproducibility of Results; D012307:Risk Factors; D012680:Sensitivity and Specificity; D013048:Specimen Handling; D019032:Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000821:virology; D014621:Vagina / Q000821:virology; D014626:Vaginal Smears / Q000295:instrumentation* / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000821:virology