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Randomized Controlled Trial
. 2021 Apr;30(4):661-668.
doi: 10.1158/1055-9965.EPI-20-1226. Epub 2021 Jan 29.

A Randomized Comparison of Different Vaginal Self-sampling Devices and Urine for Human Papillomavirus Testing-Predictors 5.1

Louise Cadman  1 , Caroline Reuter  1 , Mark Jitlal  1 , Michelle Kleeman  1   2 , Janet Austin  1 , Tony Hollingworth  1 , Anna L Parberry  3 , Lesley Ashdown-Barr  1 , Deepali Patel  1   2 , Belinda Nedjai  1 , Attila T Lorincz  1 , Jack Cuzick  4
Affiliations
Randomized Controlled Trial

A Randomized Comparison of Different Vaginal Self-sampling Devices and Urine for Human Papillomavirus Testing-Predictors 5.1

Louise Cadman et al. Cancer Epidemiol Biomarkers Prev. 2021 Apr.

Abstract

Background: Human papillomavirus (HPV)-based screening is rapidly replacing cytology as the cervical screening modality of choice. In addition to being more sensitive than cytology, it can be done on self-collected vaginal or urine samples. This study will compare the high-risk HPV positivity rates and sensitivity of self-collected vaginal samples using four different collection devices and a urine sample.

Methods: A total of 620 women referred for colposcopy were invited to provide an initial stream urine sample collected with the Colli-Pee device and take two vaginal self-samples, using either a dry flocked swab (DF) and a wet dacron swab (WD), or a HerSwab (HS) and Qvintip (QT) device. HPV testing was performed by the BD Onclarity HPV Assay.

Results: A total of 600 vaginal sample pairs were suitable for analysis, and 505 were accompanied by a urine sample. Similar positivity rates and sensitivities for CIN2+ and CIN3+ were seen for DF, WD, and urine, but lower values were seen for QT and HS. No clear user preferences were seen between devices, but women found urine easiest to collect, and were more confident they had taken the sample correctly. The lowest confidence in collection was reported for HS.

Conclusions: Urine, a DF swab, and WD swab all performed well and were well received by the women, whereas the Qvintip and HerSwab devices were less satisfactory.

Impact: This is the first study to compare five self-sampling methods in the same women taken at the same time. It supports wider use of urine or vaginal self-sampling for cervical screening.

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Conflict of interest statement

Disclosure of potential conflicts of interest

Jack Cuzick – Support to my institution from Becton Dickinson, Qiagen and Genefirst has been provided for this, and for related studies from Genera Biosystems, Hologic, and Trovagene. I have no personal conflicts to disclose. No potential conflicts of interest were disclosed by the other authors.

Figures

Figure 1
Figure 1
Study flowchart for Predictors 5.1 trial. WD: digene® Female Swab Specimen Collection Kit; DF: FLOQswab; QT: Qvintip; HS: HerSwab; 1st: first sample collected, 2nd: second sample collected
Figure 2
Figure 2
Cellularity of samples by device type. The cellularity is represented by the Ct values of the internal control (β-globin). A low Ct value indicates a higher cellularity and the vertical scale is ordered by decreasing Ct values.
See this image and copyright information in PMC

References

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