M Jentschke1, K Chen2, M Arbyn3, B Hertel4, M Noskowicz4, P Soergel4, P Hillemanns4. 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.
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.
Authors: Luana L S Rodrigues; Mariza G Morgado; Vikrant V Sahasrabuddhe; Vanessa S De Paula; Nathália S Oliveira; Elena Chavez-Juan; Diane M Da Silva; W Martin Kast; Alcina F Nicol; José H Pilotto Journal: Gynecol Oncol Date: 2018-08-04 Impact factor: 5.482
Authors: Jessica Yasmine Islam; Michael M Mutua; Emmanuel Kabare; Griffins Manguro; Michael G Hudgens; Charles Poole; Andrew F Olshan; Stephanie B Wheeler; R Scott McClelland; Jennifer S Smith Journal: Sex Transm Dis Date: 2020-07 Impact factor: 3.868
Authors: Sarah Gupta; Christina Palmer; Elisabeth M Bik; Juan P Cardenas; Harold Nuñez; Laurens Kraal; Sara W Bird; Jennie Bowers; Alison Smith; Nathaniel A Walton; Audrey D Goddard; Daniel E Almonacid; Susan Zneimer; Jessica Richman; Zachary S Apte Journal: Front Public Health Date: 2018-04-09