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.

Evaluation of BD Onclarity™ HPV Assay on Self-Collected Vaginal and First-Void Urine Samples as Compared to Clinician-Collected Cervical Samples: A Pilot Study

“…Nowadays, several devices for self-sampling are commercially available, with different performances in sample collection [ 24 , 25 , 26 ]. The majority of HPV molecular assays are validated on cervical samples, the gold standard in cervical cancer screening [ 27 ].…”

Innovations in healthcare delivery: Human papilloma virus self sampling diagnostics and participatory innovations for CCS

“…Evidence suggests that the implementation and utilization of the HerSwab sampling test will be successful in increasing CCS patronage, early detection of CC lesions, and reducing mortalities associated with CC. 37,45,46 For instance, a study conducted among women in New Zealand on HPV self-sampling acceptability reported that 78% indicated a preference for self-sample, compared to 22% who preferred a physician-collected sample. 29 Furthermore, research done in Canada among under-screened women from Rural Ontario discovered that women who received HPV self-sampling kits were 3.7 times more likely to screen than Physician collected samples.…”

“…49 It was also suggested the need to evaluate newly developed vaginal self-screening devices to increase their accessibility by women and also to identify and solve barriers that may hinder their implementation. 46 More randomized control trial studies are therefore needed across various countries to evaluate the effectiveness, acceptability, and anticipated and unanticipated challenges of implementing HerSwab tests nationwide. This new technology should be evaluated in less advanced countries such as those in Sub-Saharan Africa (SSA) to detect how well it could be introduced and well implemented in these countries.…”

“…Some authors have reported that countries like Japan that have not adopted HPV self‐sampling method have commenced clinical trial studies to evaluate its effectiveness and subsequent adoption 49 . It was also suggested the need to evaluate newly developed vaginal self‐screening devices to increase their accessibility by women and also to identify and solve barriers that may hinder their implementation 46 . More randomized control trial studies are therefore needed across various countries to evaluate the effectiveness, acceptability, and anticipated and unanticipated challenges of implementing HerSwab tests nationwide.…”

Age-specific and genotype-specific carcinogenic human papillomavirus prevalence in a country with a high cervical cancer burden: results of a cross-sectional study in Estonia

“…Improving the participation of non-attenders in CC screening programmes should be a public health priority. HPV self-sampling method proved to have a good acceptability of HPV testing, and positive attitudes towards HPV diagnostic procedures by the women, and good concordance in the detection of carcinogenic HPVs compared with cervical samples 11–13. Also, several studies have shown that offering self-sampling can lead to increased participation rates in CC screening and has been implemented already in many countries (eg, the Netherlands, Australia, Finland) 14.…”