Self‐obtained vaginal samples for HPV DNA testing to detect HPV‐related cervical disease

Objective To investigate if a self‐obtained vaginal sample (SOVAS) contains sufficient DNA for a human papillomavirus (HPV) test and if the results are comparable to those obtained via cervical samples (CS) collected by a physician. Methods One hundred and fifty‐one women who had abnormal cervical smears or who were HPV‐positive were enrolled. Self‐sampling was done after reading instructions and watching a 2‐min‐long video, whereas CS was obtained with a cervical cytobrush during a gynecologic examination. Results A multiplex real‐time polymerase chain reaction‐based assay detected the prevalence of any type of HPV to be 67.5% in the SOVAS and 57.4% in the CS, and that of high‐risk (HR‐) HPV to be 58.7% in the SOVAS and 48.6% in the CS. The sensitivity of detection of HR‐HPV in the SOVAS was 100% (95% confidence interval [CI] –0.09 to 0.32) for high‐grade squamous intraepithelial lesion, 78% (95% CI –0.09 to 0.13) for atypical squamous cells of undetermined significance or worse, and 95% (95% CI –0.01 to 0.25) for low‐grade squamous intraepithelial lesion or worse, which was statistically within the non‐inferiority margin compared with that of CS. Conclusion Our study shows that the collection of a SOVAS is feasible and it is comparable to a CS for HPV DNA testing. Future studies are required to investigate the feasibility and cost‐effectiveness of a mail‐delivered SOVAS for cervical cancer screening.