评估用于宫颈癌筛查中人类乳头瘤病毒检测的新型阴道细胞自采样装置:评估可靠性和可接受性的临床试验

IF 6.1 2区 医学 Q1 ENGINEERING, BIOMEDICAL Bioengineering & Translational Medicine 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
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引用次数: 0

摘要

宫颈癌是一个重大的公共卫生问题,尤其是在中低收入国家,因为这些国家用于预防和治疗的资源有限。常规筛查,如巴氏涂片检查(Papanicolaou test)和人类乳头瘤病毒(HPV)检测,在早期发现和预防宫颈癌方面发挥着至关重要的作用。然而,由于各种因素的影响,宫颈癌筛查项目的参与率仍未达到最佳水平。本研究旨在评估 HygeiaTouch 女性自我采样套件在采集阴道样本进行 HPV 分型时的可靠性和可接受性,并将结果与医生采集的样本进行比较。研究对象包括来自台湾三家医疗中心的 1210 名 21-65 岁女性。研究结果表明,在获取有效样本和鉴定 HPV 方面,自我采样工具包与医生采集的样本同样有效。两种方法的一致性为 88%,κ值为 0.75。此外,该研究还通过拉伸、弯曲和扭矩测试评估了自采样涂抹器的机械特性,并确定其在阴道内使用是安全的。此外,该研究还评估了自我采样的安全性和满意度,发现不良事件发生率低(0.7%),参与者满意度高(超过 90%)。总之,我们证明了 HygeiaTouch 女性自我采样套件是一种可靠、可接受的 HPV 检测和宫颈筛查设备,为女性提供了一种方便、安全、有效的选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Evaluation of a novel vaginal cells self-sampling device for human papillomavirus testing in cervical cancer screening: A clinical trial assessing reliability and acceptability

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.

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来源期刊
Bioengineering & Translational Medicine
Bioengineering & Translational Medicine Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
8.40
自引率
4.10%
发文量
150
审稿时长
12 weeks
期刊介绍: Bioengineering & Translational Medicine, an official, peer-reviewed online open-access journal of the American Institute of Chemical Engineers (AIChE) and the Society for Biological Engineering (SBE), focuses on how chemical and biological engineering approaches drive innovative technologies and solutions that impact clinical practice and commercial healthcare products.
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