Cross-Sectional Study on the Detection of HPV Infections for Cervical Cancer Screening Using a Self-Sampling Device.

OBJECTIVES

This study evaluates a new vaginal self-sampling device for high-risk human papillomavirus (HR-HPV) detection compared to clinician-collected samples using real-time polymerase chain reaction (PCR).

METHODS

A total of 345 women aged between 23 and 72 were enrolled in this study. After receiving information about the study, women were provided with a vaginal collecting device to collect self-sample, and then a medical professional collected the cervical sample. All the clinician-collected samples were processed using the Cobas 4800 HPV assay, and the self-samples were processed with the automated MAIS extraction system. These results were used to compare the new device's performance to the clinician-collected cervical samples. All the clinician-collected samples were also analyzed with a new HPV screening assay to compare the performance of this assay on 2 different types of samples.

RESULTS

Overall agreement for detecting any HR-HPV between clinician-collected samples and self-samples was 93.7% with a Cohen κ coefficient of 0.842. As both assays allow to identify genotypes 16, 18 and to detect the same 12 HR-HPV genotypes in a pool, the authors analyzed the agreement between self- and clinician-collected samples by genotypes and it was shown to be also excellent for HPV16 and the pool of other HR-HPV.

CONCLUSIONS

This self-sampling device has demonstrated detection rates that are comparable to those of samples collected by clinicians.