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

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

• Book ID: 102865477
• Publisher: John Wiley and Sons
• Year: 2011
• Tongue: French
• Weight: 858 KB
• Volume: 130
• Category: Article
• ISSN: 0020-7136
• DOI: 10.1002/ijc.26202

✦ Synopsis

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.