Improved sensitivity of vaginal self-collection and high-risk human papillomavirus testing

Int J Cancer. 2012 Apr 15;130(8):1855-60. doi: 10.1002/ijc.26202. Epub 2011 Aug 16.


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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Alphapapillomavirus / genetics
  • Alphapapillomavirus / isolation & purification
  • Cervical Intraepithelial Neoplasia / diagnosis
  • Cervical Intraepithelial Neoplasia / virology
  • Colposcopy
  • Cross-Sectional Studies
  • Female
  • Genotype
  • Humans
  • Mass Screening / instrumentation
  • Mass Screening / methods
  • Middle Aged
  • Papillomavirus Infections / diagnosis*
  • Papillomavirus Infections / virology*
  • Polymerase Chain Reaction
  • Reproducibility of Results
  • Risk Factors
  • Sensitivity and Specificity
  • Specimen Handling
  • Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization
  • Uterine Cervical Neoplasms / diagnosis
  • Uterine Cervical Neoplasms / virology
  • Vagina / virology
  • Vaginal Smears / instrumentation*
  • Vaginal Smears / methods*