[Construction and application of home self-sampling processes for cervical human papillomavirus detection]

Zhonghua Yu Fang Yi Xue Za Zhi. 2021 Sep 6;55(9):1145-1148. doi: 10.3760/cma.j.cn112150-20210126-00080.
[Article in Chinese]

Abstract

To construct and develop the home self-sampling processes of cervical human papillomavirus (HPV) detection and evaluate its application effect. An integrated HPV self-sampling detection platform is scheduled to include three terminals: a user terminal, a detection terminal and a medical terminal. It covers a wide range of functions of self-sampling kit acquisition of user, sample logistics tracking, inspection services, report query, medical consultation, health management, and follow-up tracking. A total of 8 053 users applied for self-sampling kits and all completed online user information registration from January to November 2020. The average age of users ranged from 17 to 84 with a median age of 42 years old. Registered users of the platform were distributed in Jiangsu, Jiangxi, Hebei, Shanxi, Shanghai, Ningxia, Anhui, Zhejiang, Inner Mongolia, Beijing and Xinjiang. 8 045 users completed self-sampling with a kit return rate of 99.9%. Six users lost the kits during the express delivery, and 2 users had the kits contaminated due to improper application; The amount of exfoliated cells collected from 8 045 cases in the sample kits were all within the endogenous internal standard of the nucleic acid kit, and the qualified rate of kits was 100%. The proportion of test report issued by the detection platform within 3 d accounts for 96.93% (7 799/8 054). Among the 763 positive users, 742 completed 6-month reexamination, with a reexamination rate of 97.25%. Unfortunately, 21 cases were lost to follow-up. Taken together, HPV home-based self-sampling is simple, convenient and efficient in use. It can expand the coverage of cervical cancer screening and may help promote HPV screening.

探索构建宫颈人乳头状瘤病毒(HPV)检测居家自采样流程并评价其应用效果。搭建一体化的HPV自采样检测平台,此平台有用户端、检测端、医护端3个端口,包含用户获取自采样工具、样本物流跟踪、检验服务、报告查询、医疗咨询、健康管理、随访跟踪等功能。2020年1至11月,平台共有8 053位用户申请自采样标本盒并完成线上信息注册,用户的年龄范围17~84岁、中位年龄42岁。平台注册用户分布在江苏、江西、河北、山西、上海、宁夏回族自治区、安徽、浙江、内蒙古自治区、北京、新疆维吾尔自治区。8 045位用户完成自采样,标本盒回收率99.9%,6位用户因快递运输遗失标本盒,2位用户因使用不当致取样器污染;8 045例标本盒内样本采集到的脱落细胞量均在核酸试剂盒内源性内标之内,标本盒的合格率为100%。平台出具检测报告时间在3 d内的占96.93%(7 799/8 054)。763位阳性用户中742位完成6个月的复查,复查率97.25%,21位失访。综上分析,HPV检测居家自采样流程简单、便捷、高效,可以扩大宫颈癌筛查的覆盖面,可能有助于推进HPV筛查。.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Alphapapillomavirus*
  • China
  • Early Detection of Cancer
  • Female
  • Humans
  • Middle Aged
  • Papillomaviridae
  • Papillomavirus Infections* / diagnosis
  • Uterine Cervical Neoplasms* / diagnosis
  • Young Adult