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

Jerome L. Belinson, Hui Du, Bin Yang, Ruifang Wu, Suzanne E. Belinson, Xinfeng Qu, Robert G. Pretorius, Xin Yi, Philip E. Castle

Research output: Contribution to journalArticlepeer-review

80 Scopus citations


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 (≤yen;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 ≤yen; CIN 3. For either HR-HPV assay, the sensitivity was similar for the two self-collection devices. Tested with Cervista, the sensitivity for ≤yen;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 ≤yen;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.

Original languageEnglish (US)
Pages (from-to)1855-1860
Number of pages6
JournalInternational Journal of Cancer
Issue number8
StatePublished - Apr 15 2012
Externally publishedYes


  • HPV
  • cervical cancer
  • screening
  • self-collection

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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