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J Clin Virol. 2016 Sep;82:46-50. doi: 10.1016/j.jcv.2016.06.016. Epub 2016 Jun 28.

Direct comparison of two vaginal self-sampling devices for the detection of human papillomavirus infections.

Author information

1
Department of Gynaecology and Obstetrics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany. Electronic address: Jentschke.Matthias@mh-hannover.de.
2
Department of Gynaecology and Obstetrics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany; Department of Gynaecology and Obstetrics, Tongji Hospital, Tongji University, Xin Cun Road 389#, 200065 Shanghai, China.
3
Scientific Institute of Public Health (WIV-ISP), 14, Rue Juliette Wytsman, 1050 Brussels, Belgium.
4
Department of Gynaecology and Obstetrics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.

Abstract

BACKGROUND AND OBJECTIVES:

Two devices for vaginal self-sampling of dry cell material (Evalyn Brush, Rovers Medical Devices; Qvintip, Aprovix) were compared using the Abbott RealTime High Risk HPV test.

STUDY DESIGN:

Both self-sampling devices (change of order with every patient) including instructions for use and a questionnaire were handed to 146 patients in a colposcopy clinic prior to scheduled colposcopies with collection of cervical reference specimens by gynaecologists using a broom-like device. Matched self-collected and physician collected specimens were transferred to ThinPrep medium and tested for the presence of hr-HPV. Biopsies were taken if indicated by colposcopy.

RESULTS:

Evaluation of 136 patients with complete data (136/146; 93.2%) showed high agreement of overall hr-HPV detection rates between self-collected and clinician-collected specimens (Evalyn: 91.2% [kappa 0.822]; Qvintip: 89.0% [kappa 0.779]). Colposcopy and histological evaluation revealed 55 women without cervical intraepithelial neoplasia (CIN), 32 CIN1, 34 CIN2, 14 CIN3 and one adenocarcinoma in situ. Hr-HPV testing detected all CIN3+ cases on the clinician-taken or Evalyn self-samples (14/14) and 93% of them on the Qvintip samples (13/14). There was no significant difference regarding the sensitivity for CIN2+ or CIN3+ and specificity of hr-HPV testing on self- vs. clinician samples and on Evalyn vs. Qvintip. Based on signal intensities of β-globin, the observed DNA concentration with Evalyn samples (mean CN: 22.0; 95%-CI: 21.5-22.6) was found to be significantly higher compared to that of Qvintip samples (mean CN: 23.8; 95%-CI 23.2-24.4), regardless of the order of self-sampling (p<0.0001). Most women considered self-sampling easy and comfortable. Qvintip was considered easier than the Evalyn Brush to understand (p<0.001) and to use (p=0.002).

DISCUSSION:

This study confirms that hr-HPV testing with a clinically validated PCR-based HPV assay is as accurate on self-samples as on clinician-samples without significant difference between both self-sampling devices.

KEYWORDS:

Cervical cancer screening; Human papillomavirus; Self-sampling

PMID:
27434147
DOI:
10.1016/j.jcv.2016.06.016
[Indexed for MEDLINE]

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