Comparison of Different Self-Sampling Devices for Molecular Detection of Human Papillomavirus (HPV) and Other Sexually Transmitted Infections (STIs): A Pilot Study

Abstract

Background: Cervical cancer is the fourth most common cancer in women, and it is well known that high-risk human papillomavirus (hrHPV) infections are the necessary carcinogenic factors for the development of cervical tumors. Moreover, the interaction between HPV and other sexually transmitted infections (STIs) may increase the risk of cancer progression. Self-sampling has been demonstrated to represent a valid and well-accepted alternative, favoring women's participation in screening programs. This study aimed to investigate the use of FLOQSwabs^® (FS) as compared to two other vaginal self-collection devices for the detection of hrHPV and other sexually transmitted infections.

Methods: Cervical and vaginal self-samples were collected, using two different combinations of vaginal self-sampling devices, from 40 women referred to colposcopy for a documented abnormal Pap smear. All samples were tested for hrHPV and seven STI pathogens using two commercial molecular assays.

Results: Data on hrHPV detection from the first group of women showed an almost perfect agreement (kappa: 0.89) between cervical vs. FS vaginal self-samples, and a substantial agreement (kappa: 0.79) between cervical and HerSwab™ (HS) samples. In the second group of women, an almost perfect agreement (kappa: 0.90) was demonstrated in the detection of hrHPV between cervical samples vs. FS, and a moderate agreement (kappa: 0.60) for cervical vs. Evalyn^®Brush (EB) self-collected samples. STI detections showed a very good agreement (kappa: 0.89 and kappa: 1.00) both among FS vs. HS and FS vs. EB, respectively. There was no statistically significant difference between the different devices used. The most frequently detected hrHPV genotypes in the studied population were HPV 16, 31, 35, 51, and 56; whilst the most frequently identified STI pathogens were Ureaplasma parvum and Mycoplasma hominis. Overall, investigated women did not report any discomfort in using the different vaginal self-collection devices.

Conclusion: Evaluation of the three different vaginal self-collection devices confirmed their overall good acceptability by the studied population, as well as a similar agreement for hrHPV detection as compared to cervical samples. Our study indicated that the use of self-collected samples offers an alternative strategy to improve women's participation in cervical cancer screening programs, but also underlined the importance of evaluating the concordance in hrHPV detection of collection devices in combination with the molecular hrHPV assay.

Keywords: HPV (human papillomavirus); acceptability; clinical accuracy; high-risk human papillomavirus (hrHPV); self-collected samples; sexually transmitted infections (STIs); vaginal self-sampling devices.

Figure 1

Summary of the work (flow chart).

Figure 2

Prevalence of hrHPV genotypes from cervical samples and vaginal self-samples collected using FLOQSwabs^® (FS) and HerSwab™ (HS).

Figure 3

Prevalence of hrHPV genotypes for cervical samples and vaginal self-samples collected using FLOQSwabs^® (FS) and Evalyn^®Brush (EB).

Figure 4

Prevalence of STI pathogens in cervical samples and vaginal self-samples collected using FLOQSwabs^® (FS) and HerSwab™ (HS). Seven STI pathogens were detected: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), Mycoplasma hominis (MH), Mycoplasma genitalium (MG), Ureaplasma urealyticum (UU), and Ureaplasma parvum (UP).

Figure 5

Prevalence of STIs pathogens in cervical samples and vaginal self-samples collected using FLOQSwabs^® (FS) and Evalyn^®Brush (EB). Seven STI pathogens were detected: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), Mycoplasma hominis (MH), Mycoplasma genitalium (MG), Ureaplasma urealyticum (UU), and Ureaplasma parvum (UP).