Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Clin Microbiol Infect. 2020 Sep;26(9):1144-1150. doi: 10.1016/j.cmi.2020.03.033. Epub 2020 Apr 2.
Molecular tests for detection of human papillomaviruses (HPVs) play a crucial role in the prevention of cervical cancer, including recently announced elimination efforts. HPV testing is a recommended approach for cervical cancer screening of women over 30 and for management of those with precancerous cervical lesions. In addition, they are widely used in epidemiological studies, HPV surveillance and vaccination impact monitoring.
The aim was to provide an updated 2020 inventory of commercial molecular HPV tests available on the market.
Data were retrieved from internal files, and a detailed search using Medline/Pubmed, Web of Science, Scopus, Google Scholar, Google and Bing, without language or period restrictions, was performed in September 2019 and again in January 2020.
We identified 254 distinct commercial HPV tests and at least 425 test variants available on the global market in 2020, which represents a 31% and 235% increase in the number of distinct tests and variants, respectively, compared with the previous inventory performed in 2015. Although the proportion of commercially available HPV tests with at least one peer-reviewed publication has increased over the past decade, 60% of the HPV tests on the global market are still without a single peer-reviewed publication. Furthermore, 82% of tests lack any published analytical and/or clinical evaluation, and over 90% are not evaluated in line with consensus requirements that ensure safe use in clinical settings.
Significant challenges and scope for improvement still exist for both the HPV scientific community and the manufacturers of HPV tests. The latter must put more effort into validating their products, in agreement with standardized procedures, including all steps of HPV testing and various clinical specimens. High throughput capacity and point-of-care HPV tests are needed, both with affordable prices.
人乳头瘤病毒（HPV）的分子检测在宫颈癌的预防中起着至关重要的作用，包括最近宣布的消除努力。HPV 检测是 30 岁以上女性宫颈癌筛查和管理癌前宫颈病变的推荐方法。此外，它们广泛用于流行病学研究、HPV 监测和疫苗接种效果监测。
本研究旨在提供一份 2020 年更新的市售商业分子 HPV 检测试剂清单。
数据来自内部文件，并于 2019 年 9 月和 2020 年 1 月使用 Medline/Pubmed、Web of Science、Scopus、Google Scholar、Google 和 Bing 进行了详细搜索，没有语言或时间限制。
我们确定了 2020 年全球市场上 254 种不同的商业 HPV 检测试剂和至少 425 种检测试剂变体，与 2015 年的上一次清单相比，不同的检测试剂和变体的数量分别增加了 31%和 235%。尽管过去十年中具有至少一篇同行评议出版物的商业 HPV 检测试剂的比例有所增加，但全球市场上仍有 60%的 HPV 检测试剂没有一篇同行评议的出版物。此外，82%的检测试剂缺乏任何已发表的分析和/或临床评估，超过 90%的检测试剂没有按照确保在临床环境中安全使用的共识要求进行评估。
HPV 科学界和 HPV 检测试剂制造商都面临着重大挑战和改进的空间。后者必须更加努力地按照标准化程序验证其产品，包括 HPV 检测的所有步骤和各种临床标本。需要高通量能力和即时护理 HPV 检测，同时价格也需要合理。
