1. Self-obtained vaginal samples for HPV DNA testing to detect HPV-related cervical disease
- Author
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Beob-Jong Kim, Moon-Hong Kim, Sang-Il Park, and Hee Jung Jung
- Subjects
Adult ,medicine.medical_specialty ,Cost-Benefit Analysis ,Uterine Cervical Neoplasms ,Cervical disease ,Real-Time Polymerase Chain Reaction ,Gastroenterology ,Sensitivity and Specificity ,law.invention ,Human Papillomavirus DNA Tests ,Specimen Handling ,03 medical and health sciences ,0302 clinical medicine ,law ,Internal medicine ,medicine ,Humans ,Multiplex ,030212 general & internal medicine ,Human papillomavirus ,Papillomaviridae ,Polymerase chain reaction ,Early Detection of Cancer ,Cervical cancer ,Vaginal Smears ,030219 obstetrics & reproductive medicine ,business.industry ,Papillomavirus Infections ,Obstetrics and Gynecology ,General Medicine ,Middle Aged ,medicine.disease ,Confidence interval ,Hpv testing ,Squamous intraepithelial lesion ,Self-Testing ,DNA, Viral ,Female ,business - Abstract
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.
- Published
- 2020