Excellent analytical and clinical performance of a dry self‐sampling device for human papillomavirus detection in an urban Chinese referral population. Issue 12 (20th September 2016)

• Record Type: Journal Article
• Authors: Chen, KeWei; Ouyang, YiQin; Hillemanns, Peter; Jentschke, Matthias
• Is Part Of: Journal of obstetrics and gynaecology research. Volume 42:Issue 12(2016)
• Page Start: 1839
• Page End: 1845
• Publication Date: 2016-09-20
• Subjects: cervical cancer screening -- human papillomavirus -- cervical dysplasia -- self‐sampling; Gynecology -- Periodicals; Obstetrics -- Periodicals; 618.1005
• DOI: 10.1111/jog.13132
• Languages: English
• ISSNs: 1341-8076

Abstract

Abstract: Aim: To evaluate the analytical and clinical effectiveness of cervicovaginal self‐sampling with a dry sampling device (Evalyn Brush) for high‐risk human papillomavirus (hr‐HPV) testing and detection of cervical disease. Methods: The study population consisted of 101 patients from a large gynecological outpatient clinic in Shanghai referred for abnormal cervical screening results and 101 women without cervical lesions. Self‐samples obtained in the clinic and physician‐collected cervical specimens (reference) were stored at −20 °C for 16–18 weeks and then transferred to 20 ml of ThinPrep medium and tested for hr‐HPV using a multiplex real time polymerase chain reaction assay. All women had a colposcopic examination with a Pap smear and directed or random biopsies. Results: High risk‐HPV was detected in 92 patients (45.5%) with the self‐collected cervicovaginal specimens and in 93 (46.0%) with the physician‐collected cervical specimens, resulting in an agreement of 97.5% and a Kappa of 0.95 (95% confidence interval 0.91–0.99). Among all of the included women, 46 (22.8%) had cervical intraepithelial neoplasia grade 3 or worse (cervical intraepithelial neoplasia 3+). Hr‐HPV was found in 43 of these patients (93.5%) with self‐sampling and in 44 (95.7%) with the physician‐collected specimens. Conclusions: Self‐collected dry cervicovaginal samples transferred to ThinPrep medium and tested for hr‐HPV using a clinically validated polymerase chain reaction assay showed very good agreement with physician‐collected cervical specimens and a very high hr‐HPV positivity rate for cervical intraepithelial neoplasia 3 +.