Evaluation of a novel vaginal cells self‐sampling device for human papillomavirus testing in cervical cancer screening: A clinical trial assessing reliability and acceptability,Bioengineering & Translational Medicine

当前位置： X-MOL 学术 › Bioeng. Transl. Med. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

Evaluation of a novel vaginal cells self‐sampling device for human papillomavirus testing in cervical cancer screening: A clinical trial assessing reliability and acceptability
Bioengineering & Translational Medicine ( IF 7.4 ) Pub Date : 2024-03-13 , DOI: 10.1002/btm2.10653
Chung‐Yao Yang, Ting‐Chang Chang, Hung‐Hsueh Chou, Angel Chao, Shih‐Tien Hsu, Yu‐Hsiang Shih, Huei‐Jean Huang, Cheng‐Tao Lin, Min‐Yu Chen, Lou Sun, Kuan‐Gen Huang, Kai‐Yun Wu, Wu‐Chiao Hsieh, Yi‐Ting Huang, Liang‐Hsuan Chen, Chien‐Hsing Lu, Hao Lin, Chao‐Min Cheng

Cervical cancer is a significant public health concern, particularly in low‐ and middle‐income countries where resources for prevention and treatment are limited. Routine screening, such as the Papanicolaou test (Pap smears) and human papillomavirus (HPV) testing, plays a crucial role in the early detection and prevention of cervical cancer. However, the participation rate in cervical cancer screening programs remains below optimal levels due to various factors. This study aimed to evaluate the reliability and acceptability of the HygeiaTouch Self Sampling Kit for Women in collecting vaginal samples for HPV typing, comparing the results with samples collected by physicians. The study included 1210 women aged 21–65 from three medical centers in Taiwan. The findings indicated that the self‐sampling kit was as effective as physician‐collected specimens in terms of obtaining valid samples and identifying HPV. The agreement between the two methods was 88%, with a κ value of 0.75. Furthermore, the study assessed the mechanical characteristics of the self‐sampling applicator through tensile, bending, and torque tests, and determined that it was safe for intravaginal use. Additionally, the study evaluated the safety and satisfaction of self‐sampling and found a low rate of adverse events (0.7%) and high levels of satisfaction (over 90%) among participants. Overall, we demonstrated that the HygeiaTouch Self Sampling Kit for Women is a reliable and acceptable device for HPV testing and cervical screening, providing a convenient, safe, and effective alternative for women.

更新日期：2024-03-13

点击分享查看原文

点击收藏

公开下载

阅读更多本刊最新论文

全部期刊列表>>